GAMP 5 Example Forms
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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: Risk Assessment Form
Project Title / Risk Assessment Overview Project Number
Assessment Scope / Assumptions Made
Function Sub-Function
Assessment of Risk
Measures and ControlsRelevance (GxP / Business) Risk Scenarios Probability of Occurrence
Severity Risk Class Detectability Priority
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)
3: Test Results Sheet
SYSTEMTest 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
4: Test Incident Sheet
SYSTEMTest 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
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
6: Change Request
REQUEST FOR CHANGEComputerized 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: Change Request Index
System: Sheet:
Change number
Description Disposition
accept / reject date
Number of Change Notes
Date closed
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:
9: Document Circulation Register
Sheet: DOCUMENT DETAILS DOCUMENT TITLE DOCUMENT REFERENCE DOCUMENT ISSUECONTROLLED CIRCULATION LIST
10: Document History
Sheet:
DOCUMENT TITLE
DOCUMENT REFERENCE
Date Issue Review / change
request number(s)
Updated by (initials)
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: Master Document Index
Document reference
Document title Issue
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:
14: Review Summary
Sheet: of: Review number Observation number Action agreed by Agreed completion date Date notification sent Date closed15: 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: 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 acceptanc e N/A
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: 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.
19: Example forms for the Documentation of Data Backup: Page 2
Organization of data backup for <designation of computerized system installation> Page 2Duration 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: 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)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: 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
