1. Computer Systems & Software
Validation of
Computer Systems & Software
– A Practical Approach
Presented By
Mr. Vasishtha Mehta
Director
Epitome Technologies Private Limited
Seminar on Validation Requirements for Regulatory Compliance Indian Pharmaceutical Association Date : 8th October,2011 Venue : Sci Tech Centre, Jogeshwari (W) - Mumbai

2. Topics Covered Applicability of Computer System Validation
GAMP Guide Lines & Good Practices Models
GAMP V Model & Validation Project
Practical Requirements

3. Applicability of Computer System Validation

4. Use of Automated Systems
Quality Systems
(Annual Product Review, Customer Complaints, Training Records, CAPA, SOP Administration, Adverse Event Reporting)
Facilities & Equipment Systems
Packaging & Labeling Systems
Materials Systems
Production Systems
Laboratory Systems
HVAC
Autoclaves
Calib & Maint
WFI
Inv Mgmt
Dispensary
Dist Systems
WH Mgmt
Process Inst
Control Sys
EBR
ERP
Label Gen
OCR Sys
Fill Check
Artwork
Lab Inst
LIMS
C of A
E-Notebooks

5. Automating GMP Areas Personnel Qualifications (211.25)
Consultants (211.34)
Equipment Cleaning and Maint. (211.67)
Automated Equipment (211.68)*
Written Procedures ( )
Materials Examination and Usage ( )
Packaging and Labeling Oper. ( )
Drug Product Inspection ( )
Distribution Procedures ( )
Reserve Samples ( )
Records and Reports ( )
Equipment Cleaning and Use ( )
Component, Container, Closure and Labeling Records ( )
Master Production Records ( )
Batch Production Records ( )
Production Record Review ( )
Laboratory Records ( )
Distribution Records ( )
Complaint Files ( )
Returned Drug Products ( )
Drug Product Salvaging ( )

6. System Validation - Objectives
Extensive Use of Software in GxP Environment calls for Automated Systems’ Validation to ensure
System Functioning vis-à-vis its intended use
Insurance against Data Manipulation
Data Integrity on Networks
System Performance in Validated State

7. GAMP Guidelines & Good Practices Models

8. Guidelines - GAMP
Good Automated Manufacturing Practices (GAMP) provides the Framework for Automated System Validation
Current version GAMP 5 emphasizes Risk Based Approach to Software Validation with Life Cycle Model

9. GAMP Categories Category Software Type CSV Criticality 1
Operating System
Low 2
Firmware
Removed in GAMP 5 3
Standard Software Packages
Medium - High 4
Configurable Software Packages 5
Custom or Bespoke Systems
High

10. Current Good Practices Models
Process Control Systems
PLC / DCS / SCADA / BMS
Laboratory Computerized Systems
Application Software Like HPLC /GC /FTIR etc
Global Information Systems
ERP Systems Like SAP / BaaN
Document Management Systems

11. GAMP V Model & Validation Project

12. GAMP V Model Validation Documentation Validation Plan Go Live!
User Training
Corrective / Preventative Action
Custom Monitoring Program
System Maintenance
System Usage SOP’s
Go Live!
Validation Documentation
Validation Plan
Training Records
Validation Review
Validation Planning Checklist
Final Validation Report
Risk Management Plan
Supplier Audit
Updated Risk Management Plan
User Requirement Specification
Functional Requirement Specification
Design Requirement Specification
Risk Management Plan
Trace Matrix
Installation Qualification Protocols
Final Validation Report
Sample Usage SOPs
Validation Planning Checklist
Operational Qualification Protocols
Supplier Audit
Performance Qualification Protocols
PQ Testing
Protocol Test Records
Updated Risk Management Plan
PQ Test Report
User Requirements Specification
PQ Protocols
System Usage SOP’s
User Acceptance Criteria
Sample Usage SOP’s
Functional Requirements Specification
OQ Testing
Protocol Test Records
OQ Protocols
Validation Planning Checklist
Risk Management Plan
Supplier Audit
Trace Matrix
Updated Risk Management Plan
IQ / OQ Test Report
Design Requirements Specification
IQ Testing
Protocol Test Records
User Requirement Specification
Functional Requirement Specification
Design Requirement Specification
IQ Protocols
HW /SW Requirements
Installation Qualification Protocols
Operational Qualification Protocols
Trace Matrix
Off the Shelf SOFTWARE
Customer Installation & Configuration
Updated Risk Management Plan
Configuration Drawing
Performance Qualification Protocols
Sample Usage SOPs
Final Validation Report
SysAdmin Training
Training Records
Configuration Homework

13. Practical Requirements

14. Process Control Systems
Distributed Control Systems
Programmable Logic Controllers
SCADA / BMS

15. Process Control Systems
Access Control & Password Management
Program Back Up for PLC / HMI / SCADA
Set Parameter Ranges To Be Restricted / Defined
Alarm Management
System Clock Synchronization
System Design Documents V/s Configuration Check
Printers & Reports
Electronic Records & Signatures – Wherever Applicable
Life Cycle Management

16. Laboratory Computerized Systems
Programmable instruments
Server e.g., for printing and archiving
Office computer
Instrument Software
HPLC, GC, FTIR etc
Stability Cambers, Incubators

17. Laboratory Computerized Systems
Access Control & Password Management
Adequate User Ids
Data Back Up & Restore
Data Security
Laboratory Network & Server Qualification
System Clock Synchronization
Printers & Records
Electronic Signatures & Records
Life Cycle Management

18. Global Information Systems
Enterprise Resource Planning Systems
SAP, Other ERP Packages
Document Management Systems

19. Global Information Systems - ERPs
cGMP vs. System Configuration
Interfacing of Quality Management System (BMRs) vs. ERP Records
Access Control & Password Management
Adequate User Ids
Data Back Up & Restore
Data Security
Network & Server Qualification
Paper Records vs. Electronic Records
Electronic Signatures
Life Cycle Management

20. Maintaining Control in Operation
Maintaining Control in Operation (Post Validation) Program should ensure the following –
All up-dates / new development / implementation are in line with the Change Control Procedures
Risk Assessment is carried out for all up-dates / new development / implementation
Validation documents (SOPs / Protocols / Specifications) are reviewed and updated periodically
Audit the Validation Status of various systems
Monitor the Performance of Systems Periodically

21. Road Map To Compliance
Formulate Computer System Validation Policy – Top Line Statement
Form the Core Team
Formulate Validation Master Plan
Define IT policies & Procedures
For New Systems Follow GAMP V Model – URS to PQ
For Existing Systems
Take the inventory of Systems
Carry Out Impact Analysis
Carry Out Risk Assessment for each System
Close the Gaps
Update the URS and follow GAMP v Model
Maintain Control in Operation

22. Summary
Software System Validation is Critical for All Regulatory Functions including Research and Manufacturing
Scope of CSV covers All Software Systems in GxP Area
Prevailing GAMP Guidelines Provide Framework for Designing CSV Program
GAMP Advocates Life Cycle Approach and Risk Assessment to ascertain CSV Scope
Careful Planning of CSV reduces Duplicate Activities and Cost
Identification of Electronic Records and Maintenance Thereof is Critical for All Software Systems
Maintaining Control in Operation is Essential Post Validation

23. Questions & Comments

24. Thank You For Your Attention Sincerely Yours