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Validation Summary Report For Computer System of Stability

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44 views

Validation Summary Report For Computer System of Stability

Uploaded by

mr896043
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

VALIDATION SUMMARY REPORT FOR COMPUTER SYSTEM

VALIDATION SUMMARY REPORT

FOR

COMPUTER SYSTEM

OF

STABILITY-PC

System Name STABILITY-PC


System ID
Location QUALITY ASSURANCE
Effective Date

Page 1 of 9
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

VALIDATION SUMMARY REPORT FOR COMPUTER SYSTEM


TABLE OF CONTENTS

1. PREPARATION AND APPROVALS.......................................................................................... 3


2. REVISION HISTORY .................................................................................................................. 4
3. OBJECTIVE AND SCOPE .......................................................................................................... 4
4. REFERENCES .............................................................................................................................. 4
5. ROLE AND RESPONSIBILITY .................................................................................................. 5
6. DELIVERABLE DOCUMENTS.................................................................................................. 6
7. INSTALLATION QUALIFICATION TEST STATUS .............................................................. 7
8. OPERATION QUALIFICATION TEST STATUS ..................................................................... 8
9. ABBREVIATION ......................................................................................................................... 9
10. SUMMARY & CONCLUSION .................................................................................................... 9

Page 2 of 9
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

VALIDATION SUMMARY REPORT FOR COMPUTER SYSTEM


1. PREPARATION AND APPROVALS
The signature listed below indicates the preparation and approval of this Validation summary report. This
approval is joint responsibility of listed functional areas.

REPORT DEVELOPMENT SIGN / DATE

Name : __________________
Designation : __________________

REPORT REVIEW AND APPROVAL


Sign / Date : __________________
Name : __________________
Designation : __________________
Engineering
Sign / Date : __________________
Name : __________________
Designation : __________________
IT

Sign / Date : __________________


Name : __________________
Designation : __________________
Quality Assurance

REPORT AUTHORIZATION

Sign / Date : __________________


Name : __________________
Designation : __________________
Quality Assurance

Page 3 of 9
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

VALIDATION SUMMARY REPORT FOR COMPUTER SYSTEM


2. REVISION HISTORY
Date Supersedes Reason for Revision

3. OBJECTIVE AND SCOPE


The objective of this summary report is to collect sufficient data and the qualification executed
pertaining to the Computer system of STABILITY-PC at ………………….
Successful completion of this document will provide the successfully validated of the computer
system of STABILITY-PC.
This document is applicable to environment monitoring system at ………... This report describes the
successful validation qualification for the control system.

4. REFERENCES
The publication listed below form part of this report’s reference documents. Each publication shall
be the latest revision in effect on the date this report is approved for execution unless noted
otherwise. Except as modified by the requirements specified herein or the details of the drawings,
work included in this report shall conform to the applicable provisions of these publications.
GAMP 5 Good Automated Manufacturing Practices, Version 5, Guideline
document for Automated Systems from International Society of
Pharmaceutical Engineering
21 Code of Federal Current Good Manufacturing Practice in Manufacturing,
Regulations (CFR), Part 210 Processing, Packing, or Holding off Drugs; General

21 Code of Federal Current Good Manufacturing Practice for finished


Regulations (CFR), Part 211 Pharmaceuticals
WHO Appendix 5, validation of computerized systems.
VP ICS-18.063.13-VP-R0
SRS ICS-18.063.13-SRS-R0
RA ICS-18.063.13-RA-R0
IQ ICS-18.063.13-IQ-R0
OQ ICS-18.063.13-OQ-R0
TM ICS-18.063.13-TM-R0

Page 4 of 9
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

VALIDATION SUMMARY REPORT FOR COMPUTER SYSTEM


5. ROLE AND RESPONSIBILITY
The Validation team comprising of representative from each of the following departments should be
responsible for overall compliance with this validation plan.
Department Responsibilities
 To collect data necessary for the generation, execution of this report from
M/s………….
Validation Agency  To prepare the validation summary report.
(Instrumentation and
 Comply with regulatory/Guidelines/Standards/validation plan
Control Solutions)
requirements throughout the validation life cycle.
 To submit validation documents for approval.
 Project Management and Planning.

Engineering  To provide the necessary data for qualification activities.


(M/s………..)  To co-ordinate during execution of qualification activities.
 To review and approve the validation documents.
 To provide the necessary data for qualification activities.
IT  To co-ordinate during execution of qualification activities.
(M/s……..…)
 To review and approve the validation documents.
 To provide the necessary data for qualification activities.
Quality Assurance  To co-ordinate during execution of qualification activities.
(M/s………)
 To review the validation documents.

Quality Assurance
(M/s………..)  To approve and authorize the validation documents.

Page 5 of 9
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

VALIDATION SUMMARY REPORT FOR COMPUTER SYSTEM


6. DELIVERABLE DOCUMENTS
 Validation Plan
 System Requirement Specification
 Gap and Risk Assessment
 Installation Qualification
 Operational Qualification
 Traceability Matrix
 Validation Summary Report

Page 6 of 9
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

VALIDATION SUMMARY REPORT FOR COMPUTER SYSTEM


7. INSTALLATION QUALIFICATION TEST STATUS
Discrepancy Checked
S. No. Critical Feature Pass/Fail
(Y/N) By / Date

1 Identification of System Details

2 Verification of Master Documents

3 Verification of Capacity Requirement

4 Verification of Hardware Components

5 Verification of Software Components

Verification of Physical and Logical Security


6
Control
Verification of Test Instruments Calibration and
7
Traceability

8 Verification of Power Utility

9 Verification of Environmental Condition

Verification Of Communication Link Between


10
Server To Computer System

11 Verification of General System Installation

12 Verification of Standard Operating Procedures

Page 7 of 9
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

VALIDATION SUMMARY REPORT FOR COMPUTER SYSTEM


8. OPERATION QUALIFICATION TEST STATUS

Discrepancy? Checked By
S. N. Critical Feature Pass / Fail
(Y/N) / Date

1 Verification of Field Instruments Calibration

2 Verification of Windows Security

3 Verification of System Start-up & Shutdown.

4 Verification of Password Security

6 Verification of Application software Screens.

7 Verification of System Response Failure.

8 Verification of Electronic Data Security.

9 Verification of Audit Trail .

10 Verification of Report Generation.

11 Verification of Alarms and Interlocks

Verification of User Prevented From Alternating


12
Date and Time

13 Verification of Data Back Up

Verification of system software as per 21 CFR part


14
11 Clauses

Page 8 of 9
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

VALIDATION SUMMARY REPORT FOR COMPUTER SYSTEM


9. ABBREVIATION

Abbreviations Description
GMP Good Manufacturing Practices
IS Information Services
IQ Installation Qualification
OQ Operation Qualification
QA Quality Assurance
TM Traceability Matrix
SOP Standard Operating Procedure
SRS System Requirement and Specification
TS Technical Services
WHO World Health Organization

10. SUMMARY & CONCLUSION

Compiled by: Date:

Page 9 of 9

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