IRMS Product Complaints Guide · IRMS Users Guide A more advanced, detailed guide explaining how to...

IRMS-5.8.4.0c-Product Complaints Guide.doc Last Update: (25-Nov-2009)

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Product Complaints Guide

IRMS-5.8.4.0c-Product Complaints Guide.doc

01.0

November 2, 2009


ii IRMS-5.8.4.0c-Product Complaints Guide.doc

9018 Heritage Parkway Suite 600 Woodridge, IL 60517

Phone: 630-243-9810 Fax: 630-243-9811 E-mail: [email protected] Web: http://www.IRMSOnline.com

The information in this document is proprietary. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Online Business Applications, Inc.

Information in this document is subject to change without notice. The companies, names, and data used in examples herein are fictitious unless otherwise noted.

2009 Online Business Applications, Inc. All rights reserved.

This document was produced using Microsoft Word.

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mailto:[email protected]�

http://www.irmsonline.com/�


IRMS-5.8.4.0c-Product Complaints Guide.doc iii

Table of Contents Chapter 1 Introduction ______________________________ 1-1

Welcome to IRMS ......................................................................... 1-1

Document Contents.................................................................................. 1-1 Additional Guides Available from Online Business Applications, Inc. .. 1-1

Communicating with Online Business Applications ................ 1-2

Via Phone................................................................................................. 1-2 Via Internet .............................................................................................. 1-2 Via Fax..................................................................................................... 1-2

Reporting a Problem to Online Business Applications............ 1-2

The Best Way to Report a Problem ......................................................... 1-2

How to Use this Guide ................................................................. 1-3

What this guide includes.......................................................................... 1-3 How this guide is setup............................................................................ 1-3

Chapter 2 System Administration _____________________ 2-1

Getting Started with Product Complaints ................................................ 2-1

Table Setup - General .................................................................. 2-1

Overview.................................................................................................. 2-1 PC Batch Segment ................................................................................... 2-1 PC Complaint Type.................................................................................. 2-2 PC Criticality ........................................................................................... 2-2 PC Investigation Tracking Department ................................................... 2-3 PC Justification ........................................................................................ 2-3 PC Manufacturer...................................................................................... 2-3 PC Origin of Report ................................................................................. 2-4 PC QC Confirmed Reason ....................................................................... 2-5 PC QC Investigation Reason ................................................................... 2-5 PC Reason Sample was Not Returned ..................................................... 2-6 PC Reason there was no Response to Customer...................................... 2-6 PC Reimbursement Reason...................................................................... 2-7 PC Replacement Reason .......................................................................... 2-7 PC Retrieval Package............................................................................... 2-8 PC Tracking Activity Type...................................................................... 2-8

Table Setup – QC Site Maintenance ........................................... 2-9

Overview.................................................................................................. 2-9 QC Site Maintenance screen shot ............................................................ 2-9 Entering Information into the QC Site Maintenance table ...................... 2-9

Division Parameters................................................................... 2-10


iv IRMS-5.8.4.0c-Product Complaints Guide.doc

Client Data Fields .................................................................................. 2-10 Required Fields ...................................................................................... 2-11 Required Fields tab – PC sub tab screen shot ........................................ 2-12 Required Fields tab – PC Activity sub tab screen shot.......................... 2-12 Required Fields tab - PC Invst/Corr sub tab screen shot ....................... 2-13 Other Tab of Division Parameters ......................................................... 2-14 Overview................................................................................................ 2-14 Other tab screen shot.............................................................................. 2-14 Other tab field definitions ...................................................................... 2-14 Parameter Pick List for Product Complaints ......................................... 2-14

Group Security ........................................................................... 2-15

Overview................................................................................................ 2-15 Group Security screen shot .................................................................... 2-15 Setup Group Security for Product Complaints ...................................... 2-15 Case Options Section ............................................................................. 2-15

Chapter 3 Product Complaints Entry __________________ 3-1

Launching Product Complaints...................................................................... 3-1 Overview........................................................................................................ 3-1

Step 1 – Starting a Product Complaint....................................... 3-2

Product Complaint Entry toolbar ............................................................. 3-3

Step 2 – General Info Tab ............................................................ 3-4

Overview.................................................................................................. 3-4 General Info tab screen shot .................................................................... 3-4 Entering Information into the General Info Tab ...................................... 3-4

Step 3 – General Activity tab....................................................... 3-9

Overview.................................................................................................. 3-9 General Activity tab screen shot .............................................................. 3-9 Entering Information into the General Activity Tab................................ 3-9

Step 4 – Investigation Tab......................................................... 3-13

Overview................................................................................................ 3-13 Investigation tab screen shot.................................................................. 3-13 Entering Information into the Investigation Tab ................................... 3-13

Step 5 – Investigation Tracking Tab......................................... 3-15

Overview................................................................................................ 3-15 Investigation Tracking tab screen shot .................................................. 3-15 Entering Information into the Investigation Tracking Tab .................... 3-15

Step 6 – Correspondence Tab................................................... 3-17

Overview................................................................................................ 3-17 Correspondence tab screen shot............................................................. 3-17


IRMS-5.8.4.0c-Product Complaints Guide.doc v

Entering Information into the Correspondence Tab .............................. 3-17

Step 7 – Client Data Tab ............................................................ 3-19

Overview................................................................................................ 3-19 Client Data tab screen shot .................................................................... 3-19 Entering Information into the Client Data Tab ...................................... 3-19

Step 8 – Exiting the Product Complaint Entry Screen............ 3-20

Other Toolbars............................................................................ 3-21

Case Correspondence............................................................................. 3-21

Chapter 4 Case Query_______________________________ 4-1

Finding Product Complaints Using Case Query...................................... 4-1 Product Complaint tab, General Information sub tab screen shot ........... 4-2 Product Complaint tab, General Activity sub tab screen shot ................. 4-2 Product Complaint tab, Investigation/Tracking sub tab screen shot........ 4-3 Product Complaint tab, Correspondence screen shot .............................. 4-3

Chapter 5 Reporting ________________________________ 5-1

Overview.................................................................................................. 5-1 Reports Based On Table Listings ............................................................ 5-1 Reports Using the IRMS Reporting Module ........................................... 5-2 Case Snapshot .......................................................................................... 5-3 Product Complaint Worksheet................................................................. 5-4 Product Complaint Worksheet Toolbar ................................................... 5-5 Product Complaint Worksheet................................................................. 5-5

Chapter 6 Merge Fields______________________________ 6-1

Overview.................................................................................................. 6-1

Chapter 7 Field Definitions___________________________ 7-1

Chapter 8 Index ____________________________________ 8-1

Revision History ........................................................................... 8-3

IRMS-5.8.4.0c-Product Complaints Guide.doc 1-1

Chapter 1 Introduction

Welcome to IRMS This document describes version 5 of the Information Request Management System from Online Business Applications, Inc. For up-to-date information, be sure to visit the Support area of our web site as described below.

Document Contents

IRMS Product Complaints Guide

A detailed guide explaining how to use the Product Complaints module of IRMS.

Additional Guides Available from Online Business Applications, Inc.

IRMS Administration Guide

A detailed guide explaining how to administer IRMS (adding users, setting system options, defining supporting table values, etc.).

IRMS Adverse Events Guide

A detailed guide explaining how to use the Adverse Events module of IRMS.

IRMS Document Management Guide

A detailed guide explaining how to add new documents, maintain documents, and to understand the relationship between documents and response letters.

IRMS How To Guide A short, simple guide explaining how to log into IRMS, enter new cases, create letters, and process letters.

IRMS Merge Fields Guide

A guide containing a complete listing of all the merge fields in IRMS and a complete listing of all the replacement fields in IRMS.

IRMS Reporting Guide

A detailed guide explaining how to capture the appropriate data within IRMS for reporting purposes.

IRMS Users Guide A more advanced, detailed guide explaining how to launch IRMS, enter cases, create letters, process letters, find information, and more.


Introduction

1-2 IRMS-5.8.4.0c-Product Complaints Guide.doc

Communicating with Online Business Applications

Via Phone

For technical support, phone 630.243.9810 and select extension 250.

Via Internet

Our web site at www.IrmsOnline.com contains updates, release notes, and other information.

For further information, please visit the IRMS Knowledge Base at www.IrmsOnline.com. The IRMS Knowledge Base is located under the Support drop down menu.

E-mail us at [email protected].

Via Fax

Our fax number is 630-243-9811.

Reporting a Problem to Online Business Applications It is important to notify Online Business Applications of problems. Any information provided (screen name, action being taken, etc.) will help to eliminate these issues in future releases of IRMS. Serious problems affecting the operation of IRMS will be addressed as soon as possible.

The Best Way to Report a Problem

When problems are found in IRMS, they should be reported to Online Business Applications with as much detail as possible. In many cases a printout of the screen can be very useful to us. This can be done by…

1. With the error displayed on the screen, press the Print Screen key located on the top row of the keyboard.

2. Activate Microsoft Word and start a new document.

3. Perform a Paste. (Choosing Edit from the menu bar and then choosing Paste from the options presented.)

4. If manually faxing a bug report, print the document and fax it to 630-243-9811. If electronically faxing or e-mailing, save the document to a file to be attached to the message or use File Send to [email protected].

5. Call our support staff at 630-243-9810 extension 250.






Introduction


How to Use this Guide

What this guide includes

This guide includes all the documentation needed to setup, administer and operate all the features and functionality of the Product Complaints Module. Throughout the guide, there are references to other guides for additional information outside the IRMS Product Complaints Module. Other guides that may serve as references are the IRMS Administration Guide, the IRMS Reporting Guide, and the IRMS User’s Guide.

How this guide is setup

Getting started with the Product Complaints module begins with Chapter 2 – System Administration. This chapter walks the individual through the setup of the Tables, Division Parameters and Group Security that are related to Product Complaints.

The next chapter, Chapter 3 – Product Complaint Entry walks the individual through the process of entering, tracking, recording and reporting the Product Complaint. New information on the complaint can be added at a later date. Follow-up reminders can be setup and are also discussed in this chapter.

The next two chapters, Chapter 4 – Case Query and Chapter 5 – Reporting discusses how to access and print the Product Complaint information that has been entered. The information can be queried, previewed, or printed as needed.

The next two chapters list information about the fields. Chapter 6 – Merge Fields provides a list of the Merge Fields available in Product Complaints along with an explanation of how to use the Merge Fields. Chapter 7 – Field Definitions provides an alphabetical listing of all the fields used in Product Complaints that defines what, where and how fields are used.


Chapter 2 System Administration

Getting Started with Product Complaints

This chapter explains the Administration functions that are used in the Product Complaints module. These functions include Table Setup, Division Parameters, and Group Security. These functions should be setup by an administrator with the appropriate security rights prior to using the Product Complaints module.

Table Setup - General

Overview

This section explains the pick lists values used for the Product Complaints module. For a further explanation of other Table values, refer to the General Table Maintenance section in the IRMS Administration Guide.

PC Batch Segment

The PC Batch Segment is the number assigned to the part of the batch that produced the sample in the complaint. The PC Batch Segment is entered on the General Info tab of the Product Complaint Entry screen. To enter the PC Batch Segment, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many Batch Segments as needed. A sample screen is shown below.


System Administration


PC Complaint Type

The PC Complaint Type is a brief description that summarizes the complaint. The PC Complaint Type is entered in the Complaint Description section on the General Info tab of the Product Complaint Entry screen. To enter the PC Complaint Type, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many Complaint Types as needed. A sample screen is displayed below.

PC Criticality

The PC Criticality is a brief explanation of the critical nature of the product complaint that can be assigned in Product Complaint cases. The PC Criticality is entered in the Criticality field on the General Info tab of the Product Complaint Entry screen. To enter the PC Criticality, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many criticalities as needed. A sample screen is displayed below.




PC Investigation Tracking Department

The PC Investigation Tracking Department is a description of the departments that can be assigned to work on Product Complaint cases. The PC Investigation Tracking Department is entered in the Department field on the Investigation Tracking tab of the Product Complaint Entry screen. To enter the PC Investigation Tracking Department, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many Departments as needed. A sample screen is displayed below.

PC Justification

The PC Justification is a brief explanation if the product complaint was justified. The PC Justification is entered in the Justified? field on the Ivestifation tab of the Product Complaint Entry screen. To enter the PC Justification, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many justifications as needed. A sample screen is displayed below.

PC Manufacturer

The PC Manufacturer is the name of the facility that manufactures the product involved in the Product Complaint. The PC Manufacturer is entered on the General Info tab of the Product Complaint Entry screen. To enter the PC Manufacturer, click the pick list arrow for Table




Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many Manufacturers as needed. A sample screen is displayed below.

PC Origin of Report

The PC Origin of Report is a description of where the complaint originated at. The PC Origin of Report is entered in the Origin of Complaint section on the General Info tab on the Product Complaint Entry screen. To enter the PC Origin of Report description, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many Origins as needed. A sample screen is displayed below.




PC QC Confirmed Reason

The PC QC Confirmed Reason is a brief description entered when an investigation does not confirm the complaint. For example, the product was beyond its expiration date. The PC QC Confirmed Reason is entered in the Investigation tab on the Product Complaint Entry screen. To enter the PC QC Confirmed Reason description, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many reasons as needed. A sample screen is displayed below.

PC QC Investigation Reason

The PC QC Investigation Reason is a brief description entered when an investigation will not be completed for the complaint. For example, the product was produced by another company. The PC QC Investigation Reason is entered in the Investigation tab on the Product Complaint Entry screen. To enter the PC QC Investigation Reason description, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many reasons as needed. A sample screen is displayed below.




PC Reason Sample was Not Returned

The PC Reason Sample was Not Returned is a brief description entered when a sample is not returned. For example, the product was already disposed of. The PC Reason Sample was Not Returned is entered in the Reason field in the Sample section of the General Activity tab on the Product Complaint Entry screen. To enter the PC Reason Sample was Not Returned, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many reasons as needed. A sample screen is displayed below.

PC Reason there was no Response to Customer

The PC Reason there was no Response to Customer is a brief description entered when a customer is not sent a response. For example, the customer is no longer at the contact phone number. The PC Reason there was no Response to Customer is entered in the Reason field in the Response to Customer section on the General Activity tab on the Product Complaint Entry screen. To enter the PC Reason there was no Response to Customer, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many reasons as needed. A sample screen is displayed below.




PC Reimbursement Reason

The PC Reimbursement Reason is a brief description entered when a reimbursement is not given to the customer. For example, the product will be replaced. The PC Reimbursement Reason is entered in the Reason field in the Reimbursement section on the General Activity tab on the Product Complaint Entry screen. To enter the PC Reimbursement Reason, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many reasons as needed. A sample screen is displayed below.

PC Replacement Reason

The PC Replacement Reason is a brief description entered when a replacement is not given to the customer. For example, the customer was reimbursed for the product. The PC Replacement Reason is entered in the Reason field in the Replacement section on the General Activity tab on the Product Complaint Entry screen. To enter the PC Replacement Reason, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many reasons as needed. A sample screen is displayed below.




PC Retrieval Package

The PC Retrieval Package is a brief description of the package sent to the customer to return the sample product. The PC Retrieval Package is entered on the General Activity tab on the Product Complaint Entry screen. To enter the PC Replacement Reason, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many retrieval packages as needed. A sample screen is displayed below.

PC Tracking Activity Type

The PC Tracking Activity Type is a description of the function performed as part of a tracking step. The PC Tracking Activity Type is entered on the Investigation Tracking tab on the Product Complaint Entry screen. To enter the PC Tracking Activity Type, click the pick list arrow for Table Name and select the table. The cursor will highlight the first entry for the table. Tab to the description and enter as many activities as needed. A sample screen is displayed below.




Table Setup – QC Site Maintenance

Overview

The QC Site Maintenance table creates and maintains Quality Control sites in Product Complaints. The QC Site is entered in the Investigation QC Site on the Investigation tab of Product Complaint Entry.

QC Site Maintenance screen shot

Entering Information into the QC Site Maintenance table

Name Enter the name of the QC site.

Manager Enter the manager of the QC site.

Contact Enter the primary contact for the QC site

Address Enter the address of the QC site.

Phone Enter the Phone Number of the QC site.

Fax - Enter the Fax Number of the QC site.

Class Enter the class of the QC site.

Director Enter the director of the QC site.




Division Parameters

Client Data Fields

The Product Complaints module contains ten additional fields that can be defined by the client. The Product Complaints tab of the Division Parameters defines the Client Defined fields. The additional fields can be defined with text, numeric, date, or yes/no properties. The fields will appear in Product Complaint Entry on the Client Data tab. To setup additional fields, follow the steps below.

1. Select Division Parameters…from the System menu.

2. Select the Product Complaint tab. The screen is displayed as shown below.

3. Enter up to ten PC Client Field Names in the first column. The field names cannot contain a space or the “#” character. Enter the property of the field in the second column.




Required Fields

The Product Complaints sub tab of the Required Fields tab in the Division Parameters determines what Product Complaint fields must be populated before either leaving the screen or completing the case. (When required fields are checked is determined by the RequiredFieldBehavoir parameter in the Other tab of the Division Parameters) An “*” will appear to the left of the checked items on the appropriate screen. If a user tries to leave the screen without populating a required field, an IRMS pop up window is displayed and the required fields must be populated prior to exiting the screen. For additional information, refer to the Division Parameters section in the IRMS Administration Guide. Below are instructions to define the required fields for Product Complaints.

1. Select Division Parameters…from the System menu.

2. Select the Required Fields tab.

3. Select the sub tab. Click any field that should be a required field. To uncheck a field, simply click on the field.

4. Select the and sub tab and click any field that should be required.

5. Close the Division Parameters screen.

6. Any fields that are required will now contain an * before the field name on the screens. The example below shows the Reporter as a required field. If this field is not populated and the user tries to exit the Product Complaint Entry screens, the IRMS pop up

window is displayed. Click to return to the screen and enter a value in the field. The pop up window is also shown below.




Required Fields tab – PC sub tab screen shot

Required Fields tab – PC Activity sub tab screen shot




Required Fields tab - PC Invst/Corr sub tab screen shot




Other Tab of Division Parameters

Overview

IRMS can change its behavior based on many parameters. In order to present these in a compact, yet expandable way, we have grouped them on this tab. All parameters selected in this section will apply to the entire division.

Other tab screen shot

Other tab field definitions

Parameter An individual customizable action in IRMS. The available options and a description are listed when you activate the drop down functionality of the combo box.

Description The value to assign to this parameter.

Parameter Pick List for Product Complaints

PCDisableAEReported Options are Yes or No. If “Yes,” then the AE (Yes/No), AE Report Date, and AE Reporter fields in Product Complaints are disabled. If “No”, these fields can be modified in Product Complaints.

PC_PRODUCT This parameter determines what Product Code is displayed on the General Info tab. The possible values are:

Product Code – This value is displayed on the General Info tab, but can be changed by selecting a product form the pick list.

“*DEFAULT” – The Product from the question is displayed on the General Info tab, but can be changed by selecting a product from the pick list.

“*FORCE” – The Product from the question is displayed on the General Info tab, but cannot be changed.




Group Security

Overview

There is a set of Group Security options for Product Complaints. Each sub tab of the Product Complaints Entry screen can be restricted. For a further explanation of other options, refer to the Group Security section of the IRMS Administration Guide. A sample Group Security screen is shown below.

Group Security screen shot

Setup Group Security for Product Complaints

1. From the System menu, point to Security, then click Group Security.

2. Review the Case Options for Enter PC Screen. To allow access to the specific Product Complaint tabs, click the checkbox. To uncheck the box, click the checkbox again.

3. To exit from the Group Security screen, click in the upper right corner.

Case Options Section

Enter PC Screen Allows access to the Product Complaint specific data screens. The security selections below will control access to the sub tabs on the Product Complaint Entry screens.

Modify Other




Users PC’s Allows the user to modify Product Complaint cases entered by other users.

General Info Allows access to the Product Complaint > General Info specific data screens.

General Activity Allows access to the Product Complaint > General Activity specific data screens

Investigation Allows access to the Product Complaint > Investigation specific data screens

Inv. Tracking Allows access to the Product Complaint > Investigation Tracking specific data screens

Correspondence Allows access to the Product Complaint > Correspondence specific data screens


Chapter 3 Product Complaints Entry

Launching Product Complaints

The Product Complaints module is a fully integrated module in IRMS. The module provides the ability to enter, query, and report on Product Complaint information. The main component is the Product Complaint Entry screens. There is additional security and setup required to use the Product Complaints module. For a further explanation, refer to the System Administration chapter in this guide.

Product Complaints Entry is accessed from the Case Entry screen. The Product Complaint Entry screens handles processing and tracking for samples, reimbursements, replacements, and responses to the customer along with investigation tracking and correspondence for each complaint. All the functionality of these screens is explained below.

Overview

When a Product Complaint is received, medical and contact information is entered into the Case Entry screen, the Product Complaint information is entered into a separate set of screens that is accessed from Case Entry. The Product Complaint Entry screen consists of five different tabs of information. The following steps describe how to enter and process a Product complaint.


Product Complaint Entry


Step 1 – Starting a Product Complaint 1. Access the Case Entry screen for the appropriate case number. Capture any Contact

information regarding the reporter.

2. To enter information regarding a Product Complaint, click either the toolbar button or the

button on the lower right side of the Case Entry screen.

When a Product Complaint is added to a case, “(PC #47)” text is added to the top Case Entry

bar, and the button will change to .




Product Complaint Entry toolbar

When the button is selected from Case Entry, the Product Complaint Entry toolbar is displayed along with the Product Complaint Entry screen. Below is an explanation of the buttons available on the Product Complaints Entry screen.

Button Explanation

Product Complaint Worksheet – This button previews the current Product Complaint. (Refer to the PC Worksheet in the Reporting chapter of the Product Complaints Guide for more information.)

Case Correspondence Management Screen – This button displays the Case Correspondence Management screen. (Refer to the Correspondence Tab section of the Product Complaint Guide for more information.

Delete Record – This button deletes the current Product Complaint record.

Close – This button closes the Product Complaint Entry screen.

Toolbar Options – This button allow you to add or remove buttons.




Step 2 – General Info Tab

Overview

The General Info tab of the Product Complaint Entry screen is the first tab that is displayed. Information regarding the product, origin, and complaint are captured in this tab. A sample of the screen is shown below.

General Info tab screen shot

Entering Information into the General Info Tab

1. If any fields contain an asterisk at the beginning of the field name, that field is a required field. All required fields must be populated. There is a parameter in the Division Parameters that determines when the required fields are checked.

If the RequiredFieldBehavior parameter on the Other tab in the Division Parameters is set to “Entry”, the fields will be checked prior to exiting the Product Complaint screens. If the RequiredFieldBehavior parameter is set to “Completed”, the fields will be checked prior to closing the Product Complaint. (To add or change required fields, see the Adding Required Fields to the Product Complaint Screens section in the Product Complaints Guide. To review the RequiredFieldBehavior parameter, see the Other tab in the Division Parameters in the IRMS Administration Guide.)

The example below shows the Reporter as a required field. If this field is not populated and the user tries to exit the Product Complaint Entry screens, the IRMS




pop up window is displayed. Click to return to the screen and enter a value in the field. The pop up window is also shown below.

2. The Product section gathers details about the product in the complaint.

a. Product –To enter the Product, click on the pick list arrow and select the Product or start entering the Trade Name until the correct Product Description appears in the box.

Note: The Division Parameter “PC_PRODUCT” determines if the Product Code defaults from the Question section or a specific Product Code defaults from the Division Parameter. If this parameter is not set, the Product is blank.

b. Manufacturer – To enter the Manufacturer, click on the pick list arrow and select the Manufacturer or enter the Manufacturer as free text. (To setup a Manufacturer, refer to the Table Setup section in the Product Complaints Guide.)

c. NDC# - To enter the National Drug Code Number, click on the pick list arrow and select an NDC# or start entering the NDC# until the correct NDC# appears in the box.

d. Quantity – Enter the Quantity from the original order or prescription.

e. Lot# - Enter the Lot # of the drug.

f. Exp. Date – Enter the Expiration Date of the product from the original order or prescription. If an expiration date does not apply to this complaint, enter “N/A”.

3. The Origin of Complaint section gathers information about who filed the complaint and where the complaint originated.

a. Reporter – Enter the name of the person reporting the complaint. The Reporter must be one of the Contacts for the case. Click on the pick list arrow and select the Reporter or enter the Reporter as free text. If the Reporter’s name in not one of the Contacts on the case, the Complaint Received From Not in List pop up window is displayed asking if a new Contact for this case should be setup. Click to setup a Contact in Case Entry, click to select a Contact that is already assigned to the case.




b. Origin – Click on the pick list arrow and select the Origin or enter the Origin as free text. (To setup an Origin, refer to the Table Setup section in the Product Complaints Guide.)

4. The Adverse Event Reported section records information for any Adverse Event that is associated with this Product Complaint.

Adverse Event Reported Fields

If the Adverse Event Reported fields are disabled, the PCDisableAEReported Division Parameter may be set to “Yes”.

a. Yes/No – Click on the pick list arrow and select either Yes if an Adverse Event was reported or No if an Adverse Event was not reported.

b. Report Date – If an Adverse Event was reported, enter the date it was reported.

c. AE Reporter – If an Adverse Event was reported, enter the name of the AE Reporter. Click on the pick list arrow and select the AE Reporter or enter the AE Reporter as free text. If the AE Reporter’s name in not one of the current Contacts on the case, the Complaint with AE Reported by Not in List pop up window is displayed asking if a new Contact for this case should be setup. Click to setup a Contact in Case Entry, click to select a Contact that is already assigned to the case. The Complaint with AE Reported by Not in List is shown below.

5. The *Complaint Description section gathers detailed information about the complaint.

a. Detailed Description of Complaint – Enter a detailed description of the problem in the blank text box below the Type.

b. Type – Enter a brief description for the complaint. Click on the pick list arrow and select a Type or start entering the Type as free text. (To setup a Complaint Type, refer to the Table Setup section in the Product Complaints Guide.)




6. Crosslink Button

a. The Crosslink button allows this complaint to be linked to other Product Complaints, Adverse Events, or Medical Information cases. If multiple complaints are received and are related to a single issue, this is the method to relate multiple cases to a single issue. For example, a call is received stating that the pills a customer is taking are crumbling. A couple of days later another call is received stating the same problem. The new case can be linked to the previous case with the same issue. If a case is linked to another case, all the cases that are linked are updated with the Crosslink information. The Crosslink information prints on the Case Snapshot. To link this case to another case, click

the button. The Crosslink pop up window is shown below.

b. Case – To link this Case to another case, click on the pick list arrow and select a case or begin entering a case number until the correct case number is displayed. One Product Complaint case can be linked to multiple Medical Information, Adverse Events, or Product Complaint cases.

c. Report Number – If there is a Report Number assigned to a case, the number is displayed here. The Report Number cannot be changed.

d. Contact – The Contact assigned to the case is displayed here. The Contact cannot be changed.

e. Exit the Crosslink screen – To exit the Crosslink screen, click the in the

upper right corner. The General Info tab will display in place

of the button indicating that there are linked cases.




7. The Right Side section. The fields on the right side of the screen display and/or gather additional information.

a. Receipt Date – The Receipt Date is automatically populated with the current date.

b. PC# - The Product Complaint Number that is assigned to the case is displayed. This number is automatically assigned based on the PC Number Mask defined in the Division Parameters. It should not be changed unless the number entered is from a different Product Complaint system. (See the Product Complaint Number Mask in the Division Parameters in the Admininstration Guide for further explanation)

c. Global PC Number – The Global PC Number is an optional number assigned by the user.

d. AE# - If this product complaint is associated with an adverse event, enter the Adverse Event number in the AE# field

e. Global AE Number – The Global AE Number is an optional number assigned by the user.

f. CREF # - Enter the CREF# if required.

g. Criticality – Select the Criticality from the pick list. The Criticality is defined in the “PC Criticality” in General Table Maintenance.

h. Misc Data 1 – Enter any miscellaneous information.

i. Misc Data 2 – Enter any miscellaneous information.

j. USPV# - Enter the U.S. Pharmacovigilance Number if required.

k. DQRS# - Enter the Drug Quality Reporting System Number if required.

l. Batch # - Enter the Batch # of the Product if known.

m. Segment – Enter the Segment of the Product if known. Click on the pick list arrow and select a Segment or enter the Segment as free text. (To setup a Segment, refer to the Table Setup section in the Product Complaints Guide.)

n. Complaint Closed Date – Enter the date that the Product Complaint is closed. If Required Fields should be checked when the Product Complaint is closed, an

IRMS pop up window is displayed. Click to return to the screen and enter a value in the field. A sample pop up window is shown below.

8. Proceed to step 3 by single clicking on the General Activity tab.




Step 3 – General Activity tab

Overview

The General Activity tab of the Product Complaints Entry screen records actions taken in response to the complaint. These include recording information about the sample, reimbursement, replacement, and the response to the customer. The General Activity tab is shown below.

General Activity tab screen shot

Entering Information into the General Activity Tab

1. The Sample Return section requests the following information.

a. Sample Return? – Select Yes if a sample of the product will be returned, select No if the product will not be returned.

b. Reason – If Sample Return? Is No, enter reason to the right of Sample Return? Click on the pick list arrow to select a Reason or enter the Reason free text. If Sample Return? is No, then proceed to the Reimbursement section. (To setup a Reason Sample was not Returned, refer to the Table Setup section in the Product Complaints Guide.)

c. Quantity – Enter the Quantity of the sample to be returned.




d. Description – Enter a detailed Description of the product to be returned in the blank text box to the right of the Quantity.

e. Retrieval Pkg. – Enter the retrieval package. sent to the customer. Click on the pick list arrow to select the Retrieval Pkg. or enter the Retrieval Pkg. as free text. (To setup a Retrieval Package, refer to the Table Setup section in the Product Complaints Guide.)

f. Date Return Requested – Enter the Date that the sample was requested to be returned.

g. Return Due Date – Enter the date that the sample is expected to be received from the customer. A Correspondence record with a Correspondence Type of “PC Sample Return Due” is created with a Return Due Date as the follow up date. Below is a sample of the Correspondence created.

h. Date Retrieval Sent – Enter the Date that the Retrieval Package was sent to the customer.

i. Date Sample Received – Enter the date that the sample was received from the customer.

2. The Credit / Reimbursement section requests the following information.

a. Reimbursement? – Select either Reimbursement if there will be a reimbursement for the product, Credit if there will a credit for the product, or enter None if no reimbursement or credit is issued from the pick list.

b. Reason – If Reimbursement? is No, enter a Reason to the right. Click on the pick list arrow and select a Reason or enter the Reason as free text. If Reimbursement? is No, then proceed to the Replacement section. (To setup a Reimbursement Reason, refer to the Table Setup section in the Product Complaints Guide.)

c. Description – Enter a detailed Description of the reimbursement in the blank text box below Reimbursement?.

d. Reimbursement Date – Enter the Date that the customer was reimbursed.

e. Reimbursement Amount – Enter the Amount that the customer was reimbursed.




3. The Replacement section records information about the product being replaced.

a. Replacement? – Select Yes if the product will be a replaced, or enter No if the product will not be replaced.

b. Reason – If Replacement? is No, enter a Reason to the right. Click on the pick list arrow and select a Reason or enter the Reason as free text. If Replacement? is No, proceed to the Response to Customer section. (To setup a Replacement Reason, refer to the Table Setup section in the Product Complaints Guide.)

c. Quantity – Enter the Quantity to be replaced.

d. Description – Enter a detailed Description of the replacement product in the blank text box to the right of Quantity.

e. Pharmacy – Enter the Pharmacy that will replace the product. Click on the pick list arrow and select a Pharmacy. If the Pharmacy does not appear in the pick list, return to the Case Entry screen and enter the Pharmacy as one of the Contacts. If the Pharmacy entered does not appear in the pick list, the IRMS

pop up window is displayed as shown below. Click the button to return and select a Pharmacy from the pick list.

f. Replacement Date – Enter the Date the Product was replaced.

g. Amount Paid – Enter the cost of the Product replaced.

h. Prescription Number – Enter the Prescription Number of the replacement product.

4. The Response to Customer Section requests information about the response if required.

a. Response to Customer? - Select Yes if there is a response to the customer, or enter No if there is no response.

b. Reason – If Response to Customer? is No, enter a Reason to the right. Click on the pick list arrow and select a Reason or enter the Reason as free text. (To setup a Reason there is not Response to Customer, refer to the Table Setup section in the Product Complaints Guide.)

c. Description – Enter a detailed Description of the response in the blank text field below the Response to Customer?.

d. Response Date – Enter the Date that the customer was sent a response.




e. Closure Letter – Select Yes if a Closure Letter is required, or type No if a letter is not required.

f. Priority – Enter the Priority of this investigation. Valid numbers are 0 through 9.

5. Proceed to step 4 by single clicking on the Investigation tab.




Step 4 – Investigation Tab

Overview

The Investigation tab of the Product Complaints Entry screen records information related to the investigation of the complaint.

Investigation tab screen shot

Entering Information into the Investigation Tab

1. Investigation Required? – Select Yes if an investigation is required, select No if an investigation is not required.

2. Reason – If Investigation Required? is No, enter an explanation to the right. Click on the pick list arrow and select a Reason or enter the Reason as free text. (To setup a Investigation Reason, refer to the Table Setup section in the Product Complaints Guide.)

3. Date Sample Received – Enter the date that the sample was received from the customer. When a date is entered, the “PC Sample Return Due” Correspondence record that was created when the Return Due Date was entered, is marked as completed. A sample of the updated Correspondence is shown below.




4. Investigation Description – Enter a detailed explanation of the QC investigation in the blank text box.

5. Investigation Start Date – Enter the Date the QC investigation started.

6. Investigation QC Site – Enter the QC Site that is in charge of performing the investigation. Click on the pick list arrow and select the QC Site. If the Investigation QC Site entered does not appear in the pick list, the IRMS pop up window is displayed

as shown below. Click the button to return and select an Investigation QC Site from the pick list. (To setup an Investigation QC Site, refer to the Tables Setup section in the Product Complaints Guide.)

7. Investigation End Date – Enter the date the QC Investigation was completed.

8. Description of Return – Enter a detailed explanation of the product that was returned in the blank text box.

9. Return Quantity – Enter the quantity of the sample received from the customer.

10. Complaint Confirmed? – Select Yes if the complaint was confirmed by the investigation, select No if the investigation did not confirm the complaint.

11. Justified – Select the Justified value from the pick list. The Justified value is defined in “PC Justified” in General Table Maintenance.

12. Reason – If the Complaint Confirmed? is No, enter a reason why the investigation results did not confirm the complaint. Click on the pick list arrow and select a Reason or enter the Reason free text. (To setup a Confirmed Reason, refer to the Table Setup section in the Product Complaints Guide.)

13. QC Site Investigation # - If the QC Investigation Site assigned a number to the complaint, enter the QC Site Investigation #.

14. Final Report Summary – Enter a detailed description of the final results of the investigation in the blank text box.

15. Proceed to step 5 by single clicking on the Investigation Tracking tab.




Step 5 – Investigation Tracking Tab

Overview

The Investigation Tracking tab of the Product Complaints Entry screen records the actions and progress of the investigation. Multiple activities can be recorded and tracked at the same time.

Investigation Tracking tab screen shot

Entering Information into the Investigation Tracking Tab

1. Activity Date – The Activity Date will be pre-populated by IRMS with the current date. The date can be changed if needed.

2. Activity Type - Enter the type of activity to be performed. (For example: PC Activity, paperwork, investigation, etc.) Click the pick list arrow and select an Activity Type or enter the Activity Type as free text.(To setup an Activity Type, refer to the Table Setup section in the Product Complaints Guide.)

3. Department – Enter the Department to perform the activity. Click on the pick list arrow and select a Department or enter the Department as free text. (To setup a Department, refer to the Table Setup section in the Administration Guide.)

4. Date Sent – Enter the Date any information was sent to the Department performing the Activity.




5. Date Received – Enter the Date that any information or material was received from the investigating department.

6. Description – Enter a detailed description of the activity in the blank text box for this activity.

7. Proceed to step 6 by single clicking on the Correspondence tab.




Step 6 – Correspondence Tab

Overview

The Correspondence tab of the Product Complaints Entry screen records correspondence that is sent and sets up any follow up dates needed. Multiple correspondence records can be setup.

Correspondence tab screen shot

Entering Information into the Correspondence Tab

1. Contact Name – Enter the Contact Name. Click on the pick list arrow and select a Contact Name. If the Contact Name entered does not appear in the pick list, the IRMS

pop up window is displayed as shown below. Click the button to return and select a Contact Name from the pick list.




2. Action – Enter the Action that is being taken. Click on the pick list arrow and select an Action or enter the Action free text. (To setup an Action, refer to Correspondence Action in the General Table Maintenance section in the IRMS Administration Guide.)

3. Reply Required – If a reply is required click on the checkbox. The Follow-Up Date will be populated with the current or future date calculated from the number of days in the Correspondence Type. The date can be changed. (To setup a Correspondence Type, refer to the General Table Maintenance in the Administration Guide.)

4. Completed – If this correspondence is complete, click the checkbox. The Completed Date will automatically be populated with today’s date. The Completed Date can be changed.

5. Add Notes – Click on the Add Notes button to enter any additional information about the correspondence. The Correspondence Notes pop up window is displayed. Enter information into the blank text box. To close the window, click on the ‘X’ in the upper right hand corner. The correspondence screen will display in place of the button.

6. Correspondence Date – The Correspondence Date is automatically populated with the current date when any information is entered for this correspondence.

7. Correspondence Type – Enter the Type of correspondence being taken. Click on the pick list arrow and select a Correspondence Type or enter the Type as free text. (To setup a Type, refer to Correspondence Type in the General Table Maintenance section of the IRMS Administration Guide.)

8. Notify via E-mail – Enter the E-mail address of the person to notify of this action. Click on the pick list arrow and select an E-mail address or enter the e-mail address as free text. This pick list displays the IRMS Users’ e-mail addresses.

9. Proceed to Step 7 to exit the Product Complaint Entry screen.




Step 7 – Client Data Tab

Overview

The Client Data tab of the Product Complaints Entry screen allows an individual to enter information specific to the company. The Client Data Fields are defined in the Division Parameters on the Product Complaint tab. For more information, see the Division Parameters section in this guide. A sample screen is shown below.

Client Data tab screen shot

Entering Information into the Client Data Tab

Fields 1 through 10 – If Client Data fields are used, enter any information specific to your company into these fields. If there are no Client Data fields defined, this screen is displayed with no fields for entry. The background of the fields will be highlighted in white to indicate the property of the field. The property of the field can be text, numeric, date format, or Y/N.




Step 8 – Exiting the Product Complaint Entry Screen Many times you may need to exit the Product Complaint module while waiting for additional information. To exit the PC entry screens, simply click the in the upper right hand corner of

the screen, or click the button on the toolbar. If a required field has not been completed, you will be notified at this time. (See the Required Fields section in the Product Complaints Guide for a detailed explanation.)

If the Division Parameters require an explanation of why the Product Complaint record was changed, the PC Update pop up window is displayed as shown below.

Enter the Reason for changing the PC record in the blank text box and click . The Product Complaint is closed and the Case Entry screen is displayed.

If no further explanation is required, the Product Complaint Entry screen is closed and the Case Entry screen is displayed.

If the case is still open, then you will be asked if you would like to put a “Hold” on the case so that IRMS will not automatically close the case for any reason. The Hold this Case Open? pop up window is displayed as follows:

To hold the case open, click . . To close the case when the letter(s) have been sent, click .

If the case is already closed, the Hold this Case Open? pop up window will not be displayed.




Other Toolbars

Case Correspondence

The Case Correspondence toolbar is displayed when the button is selected from the Product Complaint Entry toolbar. Below is an explanation of the buttons available on the Case Correspondence Entry screen.

Case Correspondence Toolbar screen shot

Button Explanation

Response Letter Screen – This button opens the Response Letter screen. (Refer to the Functionality for the Response Letters Screen chapter in the User’s Guide for more information.)

Delete Record – This button deletes the current Case Correspondence record.

Close – This button will close the Case Correspondence screen.



Chapter 4 Case Query

Finding Product Complaints Using Case Query

The Query Cases option from the IRMS Main Menu allows the same selection and reporting capabilities as for Case Entry. There are Types and a Query tab for Product Complaints. For a further explanation of how to find cases using Case Query, see the Finding Records with a Query section in the IRMS Reporting Guide.

To enter Case Query, select the Query Cases option from the IRMS Main Menu. The Case / Contact tab is displayed. The lower section of the Case / Contact tab on the Case Query screen identifies the Select Listing Selections section for the query. There are three Query Listing Types for Product Complaints. To select a Listing Type, click on the pick list arrow in the Type field and select a Listing Type. An explanation what is displayed using the Listing Types for Product Complaints follows.

Product Complaint(s) – The Product Complaint Listing Type displays the following fields: Case Number, PC Number, AE Number, CREF#, Plant #, USPV#, DQRS#, Rx#, Reporter, Pharmacy, Origin of Report, Associated with AE, Complaint Type, Complaint Description, and Entered Date and Time.

Product Complaint Drug(s) – The Product Complaint Drugs Listing Type displays the following fields: Case Number, PC Number, NDC #, Quantity, Trade Name, Lot #, Expiration Date, Batch #, Segment, Manufacturer, and Entered Date and Time.

Product Complaint Enhanced – The Product Complaint Enhanced Listing Type displays the following fields: Case Number, PC Number, AE Number, CREF#, QC Site, USPV#, DQRS#, Rx#, Origin of Report, Associated with AE, Complaint Type, Complaint Description, Trade Name, Sample Return, Reimbursement, Replacement, QC Investigation, Response to Customer, and Entered Date and Time.

After selecting the Listing Type, select the Product Complaint cases to query. Click on the Product Complaint tab to display the sub tabs. The General Info, General Activity, Investigation/Tracking, and Correspondence sub tabs are displayed. The sub tabs mirror the Product Complaint Entry screens. The Investigation and Investigation Tracking tabs are combined into the Investigation/Tracking sub tab. Click on each tab to enter the selection criteria. After selecting the criteria for each tab, complete the query as normal. A screen shot of the Product Complaint sub tabs is shown below.


Case Query


Product Complaint tab, General Information sub tab screen shot

Product Complaint tab, General Activity sub tab screen shot


Case Query


Product Complaint tab, Investigation/Tracking sub tab screen shot

Product Complaint tab, Correspondence screen shot


Chapter 5 Reporting

Overview

There are several reports available in Product Complaints. Reports can be selected from the Table Listings or generated using the IRMS Report Wizard. For a further explanation of how to print the reports, refer to the Reports Based on Table Listing chapter or the Steps to Creating a Report section in the IRMS Reporting Guide. Below is an explanation of the Product Complaint reports that are available.

Reports Based On Table Listings

The Table Listings are selected by clicking on the button from the IRMS toolbar and

selecting . The IRMS List Selection screen is displayed with the available report listings in IRMS. The Product Complaint Reports available in the IRMS List Selection are explained below.

Product Complaint Metrics – This report will print complaints by Type, Product, and Origin of Complaint for each month of the requested year. The Product Complaint Metric Year pop up window is shown below. The current year is displayed in the pop up window. Enter the

Year for the report and click . A sample of the pop up window and report follows.


Reporting


Reports Using the IRMS Reporting Module

The Reporting Module consists of several predefined report formats that can be sorted and summarized in different ways. Report Groups can be defined for a set of related reports printed periodically. The IRMS Report Wizard uses report formats to select, format, sort, and summarize information in different ways. For a further explanation of how to use the Report Wizard, see the Steps to Creating a Report chapter in the IRMS Reporting Guide. The Product Complaint Format available in the Report Wizard is explained below.

Complaint Detail – The Complaint Detail format provides access to the Product Complaint information. The Report Wizard prompts for information to create the report. Below is a sample report using the Complaint Detail format.


Reporting


Case Snapshot

When a Product Complaint is entered for a case, the Case Snapshot will print the Product Complaint information. For a further explanation, refer to the Printing Case Snapshots section in the IRMS User’s Guide. A Case Snapshot with the Product Complaint information is shown below.

Case Snapshot with Product Complaint Information


Reporting


Product Complaint Worksheet

The Product Complaint Worksheet previews all the Product Complaint information available for the current case. Once the Product Complaint Worksheet is displayed, the worksheet can be printed, emailed or saved in a different format. When the Product Complaint Worksheet is selected, a Product Complaint Worksheet toolbar is displayed. Below is an explanation of the toolbar options, followed by the options for the Product Complaint Worksheet.

Product Complaints Worksheet Toolbar and Product Complaint Worksheet


Reporting


Product Complaint Worksheet Toolbar

The Product Complaint Worksheet toolbar is displayed when the button is selected from the Product Complaint Entry toolbar. Below is an explanation of the buttons available on the Product Complaint Worksheet toolbar.

Button Explanation

Print – This button prints the Product Complaint Worksheet.

One Page – This button displays one page of the Product Complaint Worksheet.

Multiple Pages – This button displays multiple pages of the Product Complaint Worksheet.

Zoom – This button increases or decreases the size of the report displayed on the screen. To increase or decrease the size, click the pick list arrow and select a percentage.

E-mail As… - This button sends an e-mail of the PC Worksheet as a PDF, RTF, or Snapshot format. This option is explained in further detail below.

Save As… - This button saves the PC Worksheet in an Excel, PDF, RTF, Snapshot or Text format. This option is explained in further detail below.

Close – This button will close the Product Complaint Worksheet screen and display the Product Complaint Entry screen.


Product Complaint Worksheet

Preview the Worksheet - To preview the worksheet, select the button on the Product Complaints toolbar. The Product Complaint Report is displayed.

Print the PC Worksheet – To print the Worksheet, select from the Product Complaint Worksheet toolbar. The Product Complaint Report is printed to the printer.

E-mail the PC Worksheet – To e-mail the Worksheet, select from the Product Complaint Worksheet toolbar. Select the appropriate option from the pick list selection. Below is an explanation of the options with the E-Mail As… pick list shown below.


Reporting


PDF – Select to create a PDF and display the Copy of the report ‘Product Complaint Worksheet - Message pop up window. To e-mail the PDF,

enter the e-mail address and click . To cancel the e-mail, click . A sample Copy of the report screen is shown below.

Rich Text (RTF) – Select to display the Copy of the report ‘Product Complaint Worksheet - Message pop up window and e-mail the PC Worksheet in an RTF format. To e-mail the Product Complaint Worksheet, enter

the e-mail address and click . To cancel this e-mail, click .

Snapshot – Select to display the Copy of the report ‘Product Complaint Worksheet - Message pop up window and e-mail the Product Complaint Worksheet in a Snapshot format. To e-mail the PC Worksheet, enter

the e-mail address and click . To cancel this e-mail, click .

Save the PC Worksheet – To save the PC Worksheet, select from the PC Worksheet toolbar. Select the appropriate option from the pick list selection. Below is an explanation of the options with the Save As… pick list shown below.


Reporting


Excel (XLS) – Select to save the Product Complaint Worksheet in an Excel format. The Destination for Report in Excel Format pop up window is displayed. To save the worksheet enter the Filename and Folder, then click

. To cancel this e-mail, click . The Destination for Report in Excel Format is shown below.

PDF – Select to save the Product Complaint Worksheet as a PDF. The Destination for Report in PDF Format pop up window is displayed. To

save the worksheet enter the Filename and Folder, then click . To

cancel the save, click .

Rich Text (RTF) – Select to save the Product Complaint Worksheet in an RTF format. The Destination for Report in Rich Text Format pop up window is displayed. To save the worksheet enter the Filename and Folder,

then click . To cancel the save, click .

Snapshot – Select to save the Product Complaint Worksheet as a Snapshot. The Destination for Report in Snapshot Format is displayed. To

save the worksheet enter the Filename and Folder, then click . To

cancel the save, click .

Text Format – Select to save the Product Complaint Worksheet in a Text format. The Destination for Report in Text Format is displayed. To save

the worksheet enter the Filename and Folder, then click . To cancel the

save, click .


Chapter 6 Merge Fields

Overview

There are many Product Complaint fields within IRMS that can be accessed in the Response Letters through the use of Microsoft Word Merge Fields and Replacement Fields For more information on the merge and replacement fields, see the IRMS Field Codes Guide.


Chapter 7 Field Definitions

Screen Name Definition Tab Name Table Maintenance

Action The action that was taken on the correspondence

Correspond-ence tab Tables – General

Correspondence Action

Activity Date The date the investigation tracking record was initiated.

Investigation Tracking tab

N/A

Activity Type The type of activity initiated for investigation tracking


Tables – General

PC Tracking Activity Type

Adverse Event Reported?

Is this product complaint associated with an adverse event?

General Info tab Yes/No field

AE Reporter If there is an Adverse Event, the name of the Contact reporting the AE.

General Info tab N/A

AE# The Adverse Event # if this Product Complaint is associated with an Adverse Event.

General Info tab AE# field in the Adverse Event module

Batch # The batch number that this sample was a part of. This field will also capture the batch size.


Closure Letter Was a Closure Letter sent? Yes or No. General Activity tab Yes/No field

Complaint Confirmed?

Was this complaint confirmed? Yes or No Investigation tab Yes/No field

Complaint Closed Date

The date this Product Complaint was closed


Complaint Description Narrative Box (unlabeled)

A detailed description of the problem with this product.


Completed (Checkbox)

Is this correspondence completed? Correspond ence tab Checkbox

Completed Date The date the correspondence was completed.

Correspond-ence tab N/A

Contact Name The name of the person involved in the correspondence

Correspond-ence tab Case Entry

Contact

Correspondence Date

The date the correspondence was initiated.

Correspond-ence tab N/A`

Correspondence Type

The type of correspondence for this record

Correspond-ence tab Tables – General

Correspondence Type

CREF# A Product Complaint reference number assigned by the individual.



Field Definitions



Criticality The type of criticality assigned to the product complaint

General Info tab Tables – General

PC Criticality

Crosslink (button) Starts the Crosslink screen, allowing you to link this case with another case in IRMS.


Date Received The date that any information was received from the investigating department.


N/A

Date Retrieval Sent The date that the Retrieval Package was sent to the customer.

General Activity tab N/A

Date Return Requested

The date that your company requested the sample to be returned.


Date Sample Received

The date that the sample was received from the customer.

Investigation tab N/A

Date Sent The date the any information was sent to the investigating department


N/A

Department The department that will perform the investigation tracking activity


Tables – General

PC Investigation Tracking Department

Description A detailed description of the investigation activity.


N/A

Description (Reimburse-ment?)

A detailed description of the reimbursement.


Description (Replace-ment?)

A detailed description of the replacement. General Activity tab N/A

Description (Response to Customer?)

A detailed description of the response to the customer

General Activity tab `N/A

Description of Return

A detailed explanation of the sample that was returned.


Description (Sample Return?)

A detailed description of the sample. General Activity tab N/A

DQRS# The Drug Quality Reporting System number of this sample.


Exp. Date The expiration date of the sample from the original order or prescription.


Final Report Summary

A detailed explanation of the findings of the investigation.

Investigation tab N?A


Field Definitions



Follow-up Date The date to follow up on this correspondence

Correspondence tab N/A

Global AE Number Any optional number assigned by the user to identify the AE case associated with the Product Complaint


Global PC Number Any optional number assigned by the user to identify this Product Complaint


Investigation Description

A detailed description of the quality control investigation.

Investigation tab n/a

Investigation End Date

The date that the QC was completed. Investigation tab N/A

Investigation QC Site

The name of the site that will perform the QC investigation.

Investigation tab Tables – QC Site…

Investigation Required?

Will a Quality Control Investigation be taking place? Yes or No

Investigation tab Yes/no field

Investigation Start Date

The date the QC investigation started Investigation tab N/A

Justified? The type of justification assigned to the product complaint

Investigation tab Tables Menu – General

PC Justification

Lot # The lot number of the sample. General Info tab N/A

Manufacturer The manufacturer of this sample. General Info tab Tables Menu – General

PC Manufacturer

Misc Data 1 Any miscellaneous information for the complaint


Misc Data 2 Any miscellaneous information for the complaint


NDC# The National Drug Code # of the drug. General Info tab Tables Menu – Product

Product Maintenance

Notify via E-mail The e-mail address of the person who the correspondence is sent to .

Correspond-ence tab System - Add/Edit Users

Origin (Origin of Complaint)

The way in which this report originated. General Info tab Tables Menu – General –

PC Origin of Report

PC# The number assigned by IRMS based on the PC Number Mask to identify this product complaint.

General Info tab System Menu – Division Parameters – Case Entry/Response

Letters tab

PC Number Mask


Field Definitions



Pharmacy The name of the pharmacy that replaced the product.

General Activity tab Case Entry – Contact Company field

Prescription Number

The prescription number of the replacement product.


Priority Select a number for the priority of this investigation.

General Activity tab Numbers 0 through 9

Product The Trade Name of the product in the complaint.

General Info tab Tables Menu - Product

QC Site Investigation Number

The number assigned by the QC site that performed the investigation.


Quantity (Product) The quantity of the product from the original order or prescription.


Quantity (Sample Return?)

The quantity of the sample being returned.


Quantity (Replacement?)

The quantity of the product that was replaced.


Reason (Complaint Confirmed?)

The Reason the Complaint was not confirmed


PC QC Confirmed Reason

Reason (Reimburse-ment?)

The Reason the customer was not reimbursed.

General Activity tab Tables Menu – General

PC Reimbursement Reason

Reason (Replace-ment?)

The Reason the product was not replaced. General Activity tab Tables Menu – General

PC Replacement Reason

Reason (Sample Return?)

The Reason the sample was not returned. General Activity tab Tables Menu – General

PC Reason Sample Was Not Returned

Reason (Investiga-tion Required?)

Reason there was no quality control investigation required.


PC QC Investigation Reason

Reason (Response to Customer?)

Reason there was no response to the customer.


PC Reason There Was No Response to

Customer

Reimburse-ment? Was the patient reimbursed for the sample? Yes or No

General Activity tab Yes/No field


Field Definitions



Reimburse-ment Amount

The amount of money reimbursed to the customer.


Reimburse-ment Date

The date the customer was reimbursed. General Activity tab N/A

Replacement Date The date that the product was replaced. General Activity tab N/A

Replacement? Was the sample replaced? Yes or No General Activity tab Yes/no field

Reply Required (checkbox)

Is a reply required for this correspondence

Correspond-ence tab Checkbox

Report Date (Adverse Event Reported)

If there was an Adverse Event, the date the AE was reported.


Reporter – (Origin of Complaint)

The name of the contact reporting the complaint

General Info tab Case Entry

Response Date The date that the customer was responded to.


Response to Customer?

Should this customer be responded to? Yes or No


Retrieval Pkg. The Retrieval Package sent to the customer to return the sample.


PC Retrieval Package

Return Due Date The date the sample is expected to be returned from the customer.

General Activity tab n/a

Return Quantity The quantity of the product received from the customer


Sample Return? Is the sample going to be returned? Yes or No.


Segment The segment of the Batch that this sample was a part of.

General Info tab Tables Menu – General –

PC Batch Segment

Type (Complaint Description)

A short description of the problem with this product.

General Info tab Tables Menu – General –

PC Complaint Type

USPV# The US Pharmacovigilence number of this sample.



Chapter 8 Index

A Adverse Event Reported ......................................................... 3-7

C Case Correspondence Toolbar .............................................. 3-23 Case Entry .............................................................................. 3-2 Case Query ............................................................................. 4-1 Case Snapshot......................................................................... 5-3 Client Data Tab..................................................................... 3-21 Client Defined Fields............................................................ 2-10 Complaint Description Section............................................... 3-7 Correspondence Tab ............................................................. 3-19 Credit / Reimbursement Section ........................................... 3-12 Crosslink Button ..................................................................... 3-8

D Division Parameters

Other Tab ........................................................................ 2-14 Required Fields ............................................................... 2-11

E Exit Product Complaints....................................................... 3-22

F Field Definitions ..................................................................... 7-1

G General Activity Tab ............................................................ 3-11

Credit / Reimbursement Section...................................... 3-12 Replacement Section ....................................................... 3-13 Response to Customer Section ........................................ 3-13 Sample Return Section .................................................... 3-11

General Info Tab..................................................................... 3-4 Adverse Event Reported Section ....................................... 3-7 Complaint Description Section.......................................... 3-7 Origin of Complaint Section.............................................. 3-5 Product Section ................................................................. 3-5

Group Security...................................................................... 2-15

I Investigation Tab .................................................................. 3-15 Investigation Tracking Tab................................................... 3-17

L Listing Type

Product Complaint Drug(s) ............................................... 4-1 Product Complaint Enhanced ............................................ 4-1 Product Complaint(s) ........................................................ 4-1

M Merge Fields ...........................................................................6-1

O Origin of Complaint Section ...................................................3-5

P PC Batch Segment...................................................................2-1 PC Complaint Type.................................................................2-2 PC Criticality...........................................................................2-2 PC Investigation Tracking Department ...................................2-3 PC Justification .......................................................................2-3 PC Manufacturer .....................................................................2-4 PC Origin of Report ................................................................2-4 PC QC Confirmed Reason ......................................................2-5 PC QC Investigation Reason...................................................2-5 PC Reason Sample was Not Returned.....................................2-6 PC Reason there was no Response to Customer......................2-6 PC Reimbursement Reason .....................................................2-7 PC Retrieval Package ..............................................................2-8 PC Tracking Activity Type .....................................................2-8 Product Complaint Entry Toolbar ...........................................3-3 Product Complaint Worksheet ................................................5-4 Product Complaint Worksheet Toolbar...................................5-5 Product Complaints

Client Data Tab................................................................3-21 Correspondence Tab ........................................................3-19 General Activity Tab........................................................3-11 General Info Tab ................................................................3-4 Investigation Tab .............................................................3-15 Investigation Tracking Tab ..............................................3-17

Product Complaints Metrics Report ........................................5-1 Product Section .......................................................................3-5

Q QC Site Maintenance ..............................................................2-9

R Replacement Fields .................................................................6-1 Replacement Section .............................................................3-13 Report Wizard

Complaint Detail................................................................5-2 Reporting an Error...................................................................1-2 Reports

Case Snapshot ....................................................................5-3 Product Complaint Worksheet ...........................................5-4 Product Complaints Metrics...............................................5-1

Required Fields .....................................................................2-11 Response to Customer Section ..............................................3-13

S Sample Return Section ..........................................................3-11 Start a Product Complaint .......................................................3-2


Index


T Table Setup

PC Batch Segment............................................................. 2-1 PC Complaint Type ........................................................... 2-2 PC Criticality..................................................................... 2-2 PC Investigation Tracking Departement............................ 2-3 PC Justification ................................................................. 2-3 PC Manufacturer ............................................................... 2-4 PC Origin of Report .......................................................... 2-4 PC QC Confirmed Reason................................................. 2-5 PC QC Investigation Reason ............................................. 2-5 PC Reason Sample was Not Returned............................... 2-6 PC Reason there was no Response to Customer................ 2-6

PC Reimbursement Reason................................................2-7 PC Retrieval Package.........................................................2-8 PC Tracking Activity .........................................................2-8 QC Site Maintenance .........................................................2-9

Technical Support ...................................................................1-2 Toolbars

Case Correspondence.......................................................3-23 Product Complaint Entry ...................................................3-3 Product Complaint Worksheet ...........................................5-5

W Welcome to IRMS.................................................................. 1-1


Index


Revision History

Rev Release Date Author Comments

1.0 5.8.4.0c 11/02/2009 Cheryl Nabors

No changes for version 5.8.4.0c

1.0 5.8.4.0 08/05/2009 Cheryl Nabors

No changes for version 5.8.4.0

1.0 5.8.3.3 05/08/2009 Cheryl Nabors


1.0 5.8.3.2 04/08/2009 Cheryl Nabors

Ch 2 System Administration General Tables Add PC Criticality to table Add PC Justification to table.

Ch 3 Enter Product Complaints Update All Screens with new screen shots Step 2 – General Info Add the following fields: Receipt Date, Global PC Number, Global AE Number, Criticality, Misc Data 1, Misc Data 2 to General Info tab. Update explanation for Type in the Credit/Reimbursement section on the General Activity tab. Add explanation Justification to the Investigation tab.

Ch 4 Case Query Update PC Case Query Screen Shots.

Ch 5 Reporting Update PC Worksheet Screen Shots.

Ch 7 Field Definitions Update Field Definitions with new fields.

1.0 5.8.3.1 03/15/2009 Cheryl Nabors

Ch 6 Merge Fields Remove Merge Field Explanation and Table containing Merge Fields. Make notation to refer to the Field Codes Guide.

Ch 7 Field Definitions Remove Merge Field Column from the table.

1.0 5.8.3.0 12/15/2008 Cheryl Nabors

Ch 2 System Administration Division Parameters Update Add Other Tab parameters for “PC_PRODUCT”.

Ch 3 Enter Product Complaints Step 2 – General Info Update Product for explanation of Division Parameter “PC_PRODUCT”.

1.0 5.8.2.1 04/01/2008 Cheryl Nabors


1.0 5.8.2.0 04/01/2008 Cheryl Ch 2 System Administration


Index


Nabors Add section for Division Parameters – Other Tab for “AEDisableAEReported”. (Implemented in 5.8.0.2)

Ch 2 System Administration Update Group Security System Options Screen only (Implemented in 5.8.0.2)

Ch 3 Product Complaint Entry Update General Tab with Note that AE Reported fields may be disabled. (Implemented in 5.8.0.2)

1.0 5.8.1 11/15/2007 Cheryl Nabors

No changes for version 5.8.1

1.0 5.8.0 09/21/2007 Cheryl Nabors


1.0 5.7.1 06/15/2007 Cheryl Nabors


1.0 5.6.0 05/31/2006 Cheryl Nabors

Ch 2 System Administration Add Product Complaint tab to Division Parameter section.

Ch 2 System Administration Update Group Security screen shot and instructions.

Ch 3 Product Complaints Entry Update Product Complaint Entry screen shots. Add Client Data tab section

Ch 4 Reporting Update Case Snapshot screen shots. Update Product Complaint Worksheet screen shot.

Ch 6 Merge Fields Update Merge Fields for expanded NDC number

1.0 Initial Issue 03/06/2006 Cheryl Nabors

Major Revision for 5.5.12.0

IRMS Product Complaints Guide · IRMS Users Guide A more advanced, detailed guide explaining how to...

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Transcript of IRMS Product Complaints Guide · IRMS Users Guide A more advanced, detailed guide explaining how to...