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.

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Example risk assessment form Example source code review form Example forms to assist with testing Example forms to assist with the process of managing a change Example forms to assist with document management Example format for a traceability matrix Example forms to support validation reporting Example forms to support backup and restore 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
Relevance (GxP / Business) Risk Scenarios Probability of Occurrence Severity Risk Class Detectability Priority

Measures and Controls

Risk Assessment Approved by:

1

2: Source Code Review Report Review no: Review subject: Design Specification reference and version: Coding Standard reference and version: Observation ID Module ID and Version Recommended Corrective Action Completed by (Name and date) Date: Reviewer: Observation Action taken Corrective action(s) completed and checked by Name: Signature: Date: 2 .

Calibration Date.) Result: Pass / Fail Incident report reference Tester Date Reviewer (if required) Date 3 .. Title of test Test run number Test result Enter Details Of Equipment Used (Model.3: Test Results Sheet SYSTEM Test reference Controlling test specification ref. Revision Of Any Software External To Supply. Etc. Simulators. Serial No.

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 Date Reviewer (if required) Date Repeatable? Yes / No (specify Change Request Number Below) Raised Change Request? Yes / No Actions Close test incident Signature Print name Date 4 .4: Test Incident Sheet SYSTEM Test reference Controlling test specification ref.

Result Date 1 2 3 4 5 6 Result Date Result Date Result Date Result Date Result Date Result Date Tester Date Reviewer (if required) Date 5 .. FAT. SAT Test Ref. Run No.5: Test Progress Sheet System Number of tests to execute Sheet Of Type of testing e.g.

details of re-testing.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* * Delete as appropriate Signature: Signature: Signature: Job title: Job title: Job title: Date: Date: Date: CHANGE DETAILS Comments: (Include either reasons for rejections. 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: 6 .

7: Change Request Index System: Sheet: Change number Description Disposition accept / reject date Number of Change Notes Date closed 7 .

8: Change Note System: Change number: Change Note number: Item number: Item reference: Item version / issue number: Details of Change to perform: Implemented by: Print name: Signature: Date: 8 .

9: Document Circulation Register Sheet: DOCUMENT DETAILS DOCUMENT TITLE DOCUMENT REFERENCE DOCUMENT ISSUE CONTROLLED CIRCULATION LIST Copy no. Name and job title Date issued 9 .

10: Document History Sheet: DOCUMENT TITLE DOCUMENT REFERENCE Date Issue Review / change request number(s) Updated by (initials) 10 .

11: Document Transmittal Notice TRANSMITTAL NUMBER: DATE: TRANSMITTAL DETAILS From: To: Please find enclosed / destroy / return* (*delete as appropriate) The following document(s) Please destroy previous issue(s)* Please return previous issue(s)* Please acknowledge receipt by signing and returning this notice Date: Signature: DOCUMENT DETAILS Document title Document reference Document issue Copy number 11 .

12: Master Document Index Document reference Document title Issue Status 12 .

Agreed by. Signature and Completion date Date cleared and Backup evidence Corrective action(s) completed and checked Signature: Print name: Title: Date: 13 .13: Review Report Review no: Date: Sheet: of: Persons present: Review subject: Observation number Observation Corrective action.

14: Review Summary Sheet: of: Review number Observation number Action agreed by Agreed completion date Date notification sent Date closed 14 .

.2 Text. Text . Environment.2 2.. or an SOP reference providing procedural control.URS reference number 2. IQ.3 8. PQ) SATEST3 7..g. Description Optional.15: Example Format for a Traceability Matrix 1.. GxP Impact? (Y/N) If Y. Test or Verification Reference (e.8 Verified by Evalreport2 2. Safety.2 N/A DS_DOC99 1.. Description 3.1. Functional Specification Reference Enter the FS reference answering the URS.g. Other Impact The system may require some formal verification or testing for reasons other than GxP.. Commercial) and for which it would be good practice to trace from requirement through design to testing.4 (a) FS33 1. 5. 15 . Where the system will not provide the functionality.. 6.0 Text.3.0 2.1. DS_DOC99 1.1. 4. Specification answering the FS. It is recommended this column notes the reason for ‘Other Impact’.2.. Comments 1. Could be the full URS definition or a brief reference to assist cross checking.78 PQ TST45 SATEST2 9.1 Key to table columns 1. or Configuration. and verified by means other than testing. 3. GxP impact (inc 21CFR11)? (Y/N) Y Y 4 Other Impact (Y/N) 5. URS Reference Number All requirements should be listed. Some requirements may be met by means other than software.. 2. Design Specification Reference 7. Test or Verification Reference A reference must be present where GxP impact = Y. 8.5. (e.2 DS_DOC1 4. 7. Functional Specification Reference 6. OQ.1 2. Text . then there must be a test reference in column 7. or a reference showing that this requirement is verified in some other way. N N Y N Met by SOP565 FS33 1. Health.. this should be made clear with a notation such as ‘Not Met’. Design Specification Reference Enter the Design. Y N FS02 3. 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.

1223444 will correct problem No Action Function will not be used by business. Patch fix ref. Test when report available prior to system acceptanc e N/A 16 .Software does not save updated records in the Purchasing Module when following Long Receipt method Identified as software error – confirmed by Vendor.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.16: Example Problem Reporting Summary Incident # Test Problem Description Cause / Solution Action Justification 530 T130/009 Test Failure . no impact elsewhere 531 T132/006 Test Failure .

Report / Document Reference PE/5P961/250 PE/5P961/251 TR/4F1956/573 TR/4F1956/213 SP/4F1956/128 TR/4F1956/173 TR/4F1956/174 TR/4F1956/175 TR/4F1956/176 TR/4F1956/178 TR/4F1956/181 Functional Specification Reference FS/4F1956/001 FS/4F1956/001 RS/4F1956/045 FS/4F1956/047 Not Applicable FS/4F1956/014 FS/4F1956/015 FS/4F1956/016 FS/4F1956/069 FS/4F1956/012 FS/4F1956/092 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 [Project Leader] [Project Manager – IT] [Validation] [Quality Assurance] Job Title Signature Date 17 . including details of the execution of approved test scripts. 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. the Recommended Actions. This review included assessment of the phase reports listed below.17: Example Format for a Validation Certificate Project Name: 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. Conclusions and an assessment of Project Status derived from the outcome of each phase: Project Number: [List documents required by Validation Plan in section below] Test Report / Document Title [those listed are for example only] Project Environment Detail Design Document Project Environment System Architecture Installation Tests – Peripherals Installation Tests – Project Environment Test Plan Test Report – Purchasing Modules Test Report – Sales Modules Test Report – Financials Modules Test Report – Quality & Production Support Modules Test Report – Custom Interfaces Test Report – Security 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.

Incremental Mon . Complete backup After change of software 1 Repetition < System designation> <Date of first use> <Reason> Etc. 18 . 1) The number of the generation is specified for every week in a calendar at the beginning of the year.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.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 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: _________________________________ 19 .

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: 20 .

21: Example Template for a Monitoring Plan Monitored Parameter Warning Limit Frequency of Observation Monitoring Tool Notification Mechanism Where Results are Documented Retention Period 21 .

com • Dircheck.jobs • Fullbackup.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 22 .com • Stop_ database.com Automatic • Check_ print queues.Utilization 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.22: Example of a Monitoring Log of a Server-based LIMS Monitored Parameter Warning Limit > 25 % at the average over 24 hours Frequency of Observation Every 10 minutes Monitoring Tool System procedure Notification Mechanism System console Where Results are Documented File with 24 hour CPU statistic Retention Period 6 month CPU.

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