GAMP 5 Example Forms Copyright in the whole and every part of this material is owned by ISPE. No reproduction for commercial purposes, resale, or other commercial use of the whole or any part of this material is allowed without the written agreement of ISPE. Where indicated, purchasers of GAMP 5 are free to use and modify this material for internal use within their organization only. The material is indicative only and intended to be neither exhaustive nor prescriptive. The GAMP 5 example templates, forms, checklists, and questionnaires are provided in Microsoft® Word (suitable for Microsoft® Word 2000 or above) or Adobe® PDF format. Please note that while every effort has been made to provide the Microsoft® Word documents in a reusable format, ISPE does not guarantee that they will appear correctly when opened in Microsoft® Word or another word processing application. The GAMP 5 example templates, forms, checklists, and questionnaires are provided for your convenience. They may be used freely within your own organization; however, they remain the property of ISPE, should not be used for commercial purposes, and are not available for resale. © Copyright ISPE 2008. All rights reserved.
Form 1 Example risk assessment form
Form 2 Example source code review form
Forms 3-5 Example forms to assist with testing
Forms 6-8 Example forms to assist with the process of managing a change
Forms 9-14 Example forms to assist with document management
Form 15 Example format for a traceability matrix
Forms 16-17 Example forms to support validation reporting
Forms 18-20 Example forms to support backup and restore
Forms 21-22 Example forms to support performance monitoring
1
1: Risk Assessment Form Project Title / Risk Assessment Overview
Project Number
Assessment Scope / Assumptions Made
Function
Sub-Function
Assessment of Risk
Measures and Controls
Relevance
(GxP / Business)
Risk
Scenarios
Probability
of Occurrence
Severity
Risk Class
Detectability
Priority
Risk Assessment Approved by:
2
2: Source Code Review Report Review no: Date: Reviewer:
Review subject:
Design Specification reference and version:
Coding Standard reference and version:
Observation ID
Module ID and Version
Observation Recommended Corrective Action Action taken
Completed by (Name and date)
Corrective action(s) completed and checked by
Name: Signature: Date:
3
3: Test Results Sheet SYSTEM Test reference
Controlling test specification ref.
Title of test
Test run number
Test result Enter Details Of Equipment Used (Model, Serial No., Calibration Date, Revision Of Any Software External To Supply, Simulators, Etc.) Result: Pass / Fail Incident report reference Tester
Date
Reviewer (if required)
Date
4
4: Test Incident Sheet SYSTEM Test reference
Controlling test specification ref.
Title of test
Test run number
Incident description (note: Test incident may be raised at any time by any party) Was the test in progress halted by this incident? Yes / No Could the test proceed after immediate short term modifications? Yes / No Detail changes required Tester Reviewer (if required)
Date Date
Repeatable? Yes / No (specify Change Request Number Below) Raised Change Request? Yes / No Actions Close test incident Signature Print name
Date
5
5: Test Progress Sheet System
Number of tests to execute
Type of testing e.g., FAT, SAT
Sheet Of
Test Ref.
Run No.
1
2
3
4
5
6
Result Date
Result Date
Result Date
Result Date
Result Date
Result Date
Result Date
Tester Reviewer (if required)
Date Date
6
6: Change Request REQUEST FOR CHANGE Computerized system: Plant/Dept: Location: Originator: Proposed change: Reason for change:
Change no: Date: Telephone no: Required by date:
CHANGE DISPOSITION & AUTHORIZATION Disposition: Authorized / Rejected* Signature: Signature: Signature:
* Delete as appropriate Job title: Job title: Job title:
Date: Date: Date:
CHANGE DETAILS Comments: (Include either reasons for rejections, details of re-testing, Change Plan reference) Number of Change Notes attached: CHANGE COMPLETION AND APPROVAL Completed signature: Approved by signature: Signature:
Job title: Job title: Job title:
Date: Date: Date:
7
7: Change Request Index System: Sheet: Change number
Description
Disposition accept / reject date
Number of Change Notes
Date closed
8
8: Change Note System: Change number:
Change Note number:
Item number: Item reference:
Item version / issue number:
Details of Change to perform: Implemented by: Signature:
Print name: Date:
9
9: Document Circulation Register Sheet: DOCUMENT DETAILS DOCUMENT TITLE DOCUMENT REFERENCE DOCUMENT ISSUE CONTROLLED CIRCULATION LIST Copy no.
Name and job title
Date issued
10
10: Document History Sheet: DOCUMENT TITLE DOCUMENT REFERENCE Date
Issue
Review / change request number(s)
Updated by (initials)
11
11: Document Transmittal Notice TRANSMITTAL NUMBER: DATE: TRANSMITTAL DETAILS From: Please find enclosed / destroy / return* (*delete as appropriate) Please destroy previous issue(s)* Please return previous issue(s)*
To: The following document(s)
Please acknowledge receipt by signing and returning this notice Signature:
Date:
DOCUMENT DETAILS Document title
Document reference
Document issue
Copy number
12
12: Master Document Index Document reference
Document title
Issue Status
13
13: Review Report Review no: Date: Sheet: of: Persons present: Review subject: Observation number
Observation
Corrective action, Agreed by, Signature and Completion date
Date cleared and Backup evidence
Corrective action(s) completed and checked Signature: Print name: Title: Date:
14
14: Review Summary Sheet: of: Review number
Observation number
Action agreed by
Agreed completion date
Date notification sent
Date closed
15
15: Example Format for a Traceability Matrix 1.URS reference number
2. Description 3. GxP impact (inc 21CFR11)? (Y/N)
4 Other Impact (Y/N)
5. Functional Specification Reference
6. Design Specification Reference
7. Test or Verification Reference (e.g., IQ, OQ, PQ)
8. Comments
1.0 Text... Y Y FS02 3.1.4 (a) DS_DOC1 4.5. SATEST3 7.8
2.0 Text ... Y N FS33 1.3.2 DS_DOC99 1.2 Verified by Evalreport2 2.78
2.1.1 Text... N Y Met by SOP565 N/A PQ TST45
2.1.2 Text ... N N FS33 1.2.2 DS_DOC99 1.1 SATEST2 9.3
Key to table columns 1. URS Reference Number All requirements should be listed. 2. Description Optional. Could be the full URS definition or a brief reference to assist cross checking. 3. GxP Impact? (Y/N) If Y, then there must be a test reference in column 7, or a reference showing that this requirement is verified in some other way. 4. Other Impact The system may require some formal verification or testing for reasons other than GxP, (e.g., Safety, Health, Environment, Commercial) and for which it
would be good practice to trace from requirement through design to testing. It is recommended this column notes the reason for ‘Other Impact’. 5. Functional Specification Reference Enter the FS reference answering the URS. Where the system will not provide the functionality, this should be made clear with a notation such as ‘Not
Met’, or an SOP reference providing procedural control. Some requirements may be met by means other than software, and verified by means other than testing.
6. Design Specification Reference Enter the Design, or Configuration, Specification answering the FS. 7. Test or Verification Reference A reference must be present where GxP impact = Y. 8. Comments Include any comments that add information particularly where reference needs to be made to additional testing or requirements that have arisen as part
of the exercise.
16
16: Example Problem Reporting Summary
Incident #
Test
Problem Description
Cause / Solution
Action
Justification
530
T130/009
Test Failure - Software does not save updated records in the Purchasing Module when following Long Receipt method
Identified as software error – confirmed by Vendor, Patch fix ref. 1223444 will correct problem
No Action
Function will not be used by business, no impact elsewhere
531
T132/006
Test Failure - Standard reports would not print when requested
Printer set-up error Update printer configuration and retest
Change Notice 1643
N/A
533
T138/001
Test Failure – Label L_MAI_001 not produced due to system error
Print Server configuration incorrectly set up – did not recognize printer driver for label printing device LP44165
Change Notice 1645
N/A
534
T142/064
Report not available at time of test
Custom report yet to be created.
Test when report available prior to system acceptance
N/A
17
17: Example Format for a Validation Certificate Project Name: Project Number:
Controlling Specification Reference: FINAL SYSTEM VALIDATION APPROVAL
The signatories below have reviewed the validation documentation for the [name of company and name of system] Computerized System. This review included assessment of the phase reports listed below, including details of the execution of approved test scripts, the Recommended Actions, Conclusions and an assessment of Project Status derived from the outcome of each phase:
[List documents required by Validation Plan in section below] Test Report / Document Title [those listed are for example only] Report / Document
Reference Functional Specification Reference
Project Environment Detail Design Document PE/5P961/250 FS/4F1956/001
Project Environment System Architecture PE/5P961/251 FS/4F1956/001
Installation Tests – Peripherals TR/4F1956/573 RS/4F1956/045
Installation Tests – Project Environment TR/4F1956/213 FS/4F1956/047
Test Plan SP/4F1956/128 Not Applicable
Test Report – Purchasing Modules TR/4F1956/173 FS/4F1956/014
Test Report – Sales Modules TR/4F1956/174 FS/4F1956/015
Test Report – Financials Modules TR/4F1956/175 FS/4F1956/016
Test Report – Quality & Production Support Modules TR/4F1956/176 FS/4F1956/069
Test Report – Custom Interfaces TR/4F1956/178 FS/4F1956/012
Test Report – Security TR/4F1956/181 FS/4F1956/092
STATUS
As a result it is determined that the [name of system] Project has been validated to date in accordance with the requirements of [Validation Plan reference] and can be used in the operational environment by suitably trained and authorized business personnel.
It is recognized that continued performance monitoring of the system will proceed after Go-Live in order to maintain the full validation requirements for this system.
APPROVAL DATE
[Must be prior to “go-live” date] By signing below, each individual approves the validation status of the [name of system] Project:
Name Job Title Signature Date
[Project Leader]
[Project Manager – IT]
[Validation]
[Quality Assurance]
18
18: Example forms for the Documentation of Data Backup: Page 1 Organization of data backup for <designation of computerized system installation>
Page 1
Data backup type
Interval
Number of generations
Behavior in the case of a failure
Remarks
Labeling of backup media
Complete backup
Sat
4
Repetition
<System designation > <Date of first application> <Number of generation> 1 Etc.
Complete backup
After change of software
1
Repetition
< System designation> <Date of first use> <Reason> Etc.
Incremental
Mon - Thur
4
No repetition
< System designation> <Date of first use> <the first two letters of the day of the week> <Number of the generation> Etc.
1) The number of the generation is specified for every week in a calendar at the beginning of the year.
19
19: Example forms for the Documentation of Data Backup: Page 2 Organization of data backup for <designation of computerized system installation> Page 2 Duration of use:
2 years
Type of backup media:
DAT
Storage of backup media:
Safe in the office of the person responsible for the PLT-system
Data backup tool:
SAM
Procedure:
xxxxxxx
Call:
Automatically Manually: xxxxxxxx
Review:
Visual check of backup protocols, to be signed
Check of 1:1 Copy:
To be evaluated
Signature / Date Person responsible for the computerized system: _________________________________
20
20: Example Form for Restoration of Data Restoration of Data Applicant: __________________________________________ Date/Time: __________________________________________ System/application name/identification Data to be restored/files: _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________
Reason: _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ Owner of data: __________________________________________ Date/Time: __________________________________________ Restored: __________________________________________ (Date/Time/person responsible for system) Side effects:
21
21: Example Template for a Monitoring Plan Monitored Parameter
Warning Limit
Frequency of Observation
Monitoring Tool
Notification Mechanism
Where Results are Documented
Retention Period
22
22: Example of a Monitoring Log of a Server-based LIMS Monitored Parameter
Warning Limit
Frequency of Observation
Monitoring Tool
Notification Mechanism
Where Results are Documented
Retention Period
CPU- Utilization
> 25 % at the average over 24 hours
Every 10 minutes
System procedure
System console
File with 24 hour CPU statistic
6 month
Disk Filling Grade
> 90 %
Hourly
System procedure
Mail to system operator
File with mail
30 days
System Error Message
Error count increased by severe system error (defined in the tool)
Every second
Tool “CheckSys“
Mail to system operator Message to operator pager with error number
According to SOP “Problem Management”
According to appropriate GxP regulations
Critical Batch Jobs: • All monitor- jobs • Fullbackup.com • Dircheck.com Automatic • Check_ print queues.com • Stop_ database.com • LIMS
If batch job is lost
Every 10 minutes
System procedure
Automatic restart of batch jobs by system procedure
File with mail
30 days
Critical Processes: • LIMS • Pathworks • Oracle • Perfect disk • UCX • DECnet • Security Audit
If process is not running
Every minute
Tool “CheckSys“
Mail to system operator
File with mail
30 days
Top Related