Download - Spreadsheet management tool presentation

Confidential 1 20-Nov-13

Manage Spreadsheets in a Regulated Environment

#59, Ground Floor, 5th Cross, Channarayappa Street, Vasanthnagar, Bangalore - 560052. | Tel no: +91- 80- 41477219

[email protected]


Contents

•About ivyworks

•Why iXLc?

• iXLc Features

• iXLc Demo

•Custom Modules

•Additional Services

• System Requirements


About ivyworks

•Compliance & Validation

• IT Services & IT Compliance Products

Services for Life Sciences

•Extensive Compliance, Validation, IT Services & Product Experience

•Worked with Top 10 Pharmaceutical Companies in USA, Europe & Asia

Experience & Exposure


Why iXLc?

Current Scenario

No Central Location

Procedural Controls

Manually Lock Cells

No E-Sign or Audit Trail

Circulate by Email

No Notifications or Reports

iXLc

Security

E-Sign & Audit Trails

Customizable Workflow

Collaboration

Email Notifications

Custom Reports

Controlled Printing


iXLc Features Template

Configuration

Collaboration

Customizable Workflow

Security

E-Sign & Audit Trails

Email Notifications

Printing

Custom Reports


Template Configuration

• Allows configuration of existing

spreadsheets

• Cell Level security based on Groups

and Workflow Stage (LockCells

containing formulae, calculations,

labels)

• Configure Cells to Capture User

Name and Date / Time Stamp at

each Workflow Stage

• Configure Cells as Mandatory or

Optional for Data Entry based on

Workflow Stage

• Allows the use of inbuilt Excel

features like Data Validation, Cell

Formatting, Decimals, Data Types,

etc.


Collaboration

• Central Location for latest

versions of approved

Templates & Spreadsheets

• Spreadsheet Check in /

Check out

• Automatic File Name

generation

• Configurable Metadata (up

to 6 parameter)

• Cell Level Commenting


Customizable Workflow • Standard 4 Stage Workflow, which can

be customized to 5 Stages (Review /

Approval)

• Configurable State Names

• Editing and Highlighting of mandatory

/ optional cells based on Workflow

Stages

• Workflow Actions based on User

Privileges (Review /Approve / Reject)

• Ensure that all mandatory cells for a

workflow stage are completed before

proceeding to the next workflow stage

• Auto submit to next workflow stage

when all mandatory cells are

completed


Security

• Access based on Security

Groups in Windows Active

Directory / LDAP

• Integrated Single Sign On or

iXLc Application Logon

• Control access to the latest

Templates and Spreadsheets

through the iXLc Application

• Prevent Local storage of

Templates & Spreadsheets

• Prevent addition or deletion

of worksheets


E-Sign & Audit Trail

• E-Sign for Review / Approval and

Saving of Spreadsheets

• Integrates with Windows Active

Directory / LDAP for E-Sign

Authentication

• Audit Trails capture

modifications to spreadsheets

(old value, new value & reason

for change)

• Compliance with 21 CFR Part 11

& EU Annexure 11

• E-Sign and Audit Trail stored in

the spreadsheet itself and

cannot be modified


Email Notification

• Configurable Email

notifications for each

workflow stage

• Configurable Email

notifications to

Users/Groups

• Email notification to

additional Email users

• Email notifications

using SMTP mail server Sample Email


Printing

• Company Name, File Name,

File Path in the header while

printing

• Date / Time, User Name,

Page Number and Number of

Pages in the footer while

printing

• Configurable text based on

spreadsheet state in the

footer while printing (Draft,

Reviewed, Approved)

• Product Name and Version in

the footer while printing


Custom Reports

• User Friendly Graphical or

Table based Reports

• Custom Reports based on

metadata and workflow stages

• Consolidated Reports from

multiple spreadsheets based on

metadata and date range

• Advanced Search based on

metadata and date range

• Ability to drill down to

files/details

• Option to print or export to PDF

COMPANY NAME

Sample Report


Custom Modules

Stability Management

Sample Management

eLogBook Cleaning

Validation

Modules


Stability Management

• Custom iXLc Module to Manage Stability

Samples

• Sample Details recorded when received

(Product, Strength, Storage Conditions,

Charged On Date, Pull Out Periods,

Expiration Date)

• Sample Details Reviewed by or Checked

by Supervisor

• Reports to display Sample Pull Out Dates

for a Particular Day, Month or Year

• Reports to display Sample Expiry Dates

for a Particular Day or Month

• Customized Reports to identify samples

based on type or storage condition

• Option to print or export to PDF

Stability Report


Sample Management

• Custom iXLc Module to Manage

Samples in Laboratories

• Sample Details recorded when

received (Sample Type,

Product, Test Parameters,

Batch Number, Sample Date,

Quantity)

• Sample Receipt Acknowledged

by various Laboratory

Departments for Testing

• Consolidated Result Entry For

Samples based on Product

• Customized Reports based on

date range, product, test

parameters, batch number

and sample type


eLogBook

• Custom iXLc Module to

Manage Logbooks

(Instrument Use, Hourly

Data Entry)

• Record One Log Entry at a

time with required details

• Automatic capture of User

Name and Date/Time of

Log Entry

• Lock all previous entries

• Review of Log Book

• View Log Book after

Review (Not Editable)


Cleaning Validation • Custom iXLc Module for Product based

Cleaning Validation using MACO/MAR

values

• Master Template containing all Products

with details and list of equipment used

for manufacture

• Record Product Details for a new product

(Product Name, Active Ingredients,Dose,

Batch Size, Dose Limit) and select

Equipment used for manufacture

• Automatic determination of required

cleaning validation for new product based

on MACO/MAR values

• Review of results

• Automatic update of Master Template

with new Product


Additional Services

Configuration of Spreadsheet Template

Validation of Spreadsheet Template in iXLc

Migration of Spreadsheet Template

Migration of Data to iXLc

Re-Validation of validated Spreadsheet Template for use with iXLc

Custom Feature Development

Custom Report Development


System Requirements


#59, Ground Floor, 5th Cross, Channarayappa Street, Vasanthnagar, Bangalore - 560052. | Tel no: +91- 80- 41477219

[email protected]

Thank You!