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
Topics Covered
Applicability of Computer System Validation
GAMP Guide Lines & Good Practices Models
GAMP V Model & Validation Project
Practical Requirements
Applicability of Computer System
Validation
Use of Automated Systems
Quality Systems
(Annual Product Review, Customer Complaints, Training Records,
CAPA, SOP Administration, Adverse Event Reporting)
Facilities &
Equipment
Systems
HVAC
Autoclaves
Calib & Maint
WFI
Materials
Systems
Inv Mgmt
Dispensary
Dist Systems
WH Mgmt
Production
Systems
Process Inst
Control Sys
EBR
ERP
Packaging &
Labeling
Systems
Label Gen
OCR Sys
Fill Check
Artwork
Laboratory
Systems
Lab Inst
LIMS
C of A
E-Notebooks
Automating GMP Areas
Personnel Qualifications (211.25)
Consultants (211.34)
Equipment Cleaning and Maint. (211.67)
Automated Equipment (211.68)*
Written Procedures (211.100)
Materials Examination and Usage
(211.122)
Packaging and Labeling Oper. (211.130)
Drug Product Inspection (211.134)
Distribution Procedures (211.150)
Reserve Samples (211.170)
Records and Reports (211.180)
Equipment Cleaning and Use (211.182)
Component, Container, Closure and
Labeling Records (211.184)
Master Production Records (211.186)
Batch Production Records (211.188)
Production Record Review (211.192)
Laboratory Records (211.194)
Distribution Records (211.196)
Complaint Files (211.198)
Returned Drug Products (211.204)
Drug Product Salvaging (211.208)
System Validation - Objectives
Extensive Use of Software in GxP Environment
calls for Automated Systems Validation to
ensure
System Functioning vis--vis its intended
use
Insurance against Data Manipulation
Data Integrity on Networks
System Performance in Validated State
GAMP Guidelines & Good Practices
Models
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
GAMP Categories
Category
Software Type
CSV Criticality
Operating System
Low
Firmware
Removed in GAMP 5
Standard Software
Packages
Configurable Software
Packages
Custom or Bespoke
Systems
Medium - High
4
5
Medium - High
High
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
GAMP V Model & Validation Project
GAMP V Model
System Usage SOPs
User Training
User Training
Validation
Documentation
Validation
Plan
Validation
Validation
Planning
Checklist
Planning
Checklist
Risk
Risk
Management
Plan
Manageme
Supplier Audit
User
Functional
Design
Requiremen
User Requiremen Requiremen
PQ Protocols
t
t
t
Requirements
Acceptance
System
Usage
Sample
Usage
Specification
Specificatio UserSpecificatio
Specificatio
Criteria
SOPs
SOPs
n
n
n
Installation
Functional
Qualificatio
Requirements
Specification
n Protocols
Validation
Validation
Review
Review
Operational
Qualificatio
OQ Protocols
n Protocols
Trace
Matrix
PQ Testing
PQ Testing
OQ Testing
OQ Testing
Protocol Test
Records
Requirements
Off the Shelf
Off the Shelf
SOFTWARE
SOFTWARE
Customer
Customer
Installation &
Installation &
Configuration
Configuration
SysAdmin
SysAdmin
Training
Training
Configuration
Drawing
Configuration
Homework
Training Records
Updated Risk
Management
Plan
Updated Risk
Management
Plan
PQ Test
Report
Protocol Test
Records
Trace
Matrix
Performanc
Final
e Design
Sample
Validation
RequirementsUsage
Qualificatio
SOPs
IQ Testing
IQ Protocols
Report IQ Testing
Specification
HW /SW
n Protocols
Protocol Test
Records
Final
Validation
Report
System Maintenance
Custom Monitoring
Program
Training Records
Supplier
Audit
nt Plan
Go
GoLive!
Live!
Corrective / Preventative
Action
Updated Risk
Management
Plan
Validation
Planning
Updated Risk
IQ / OQ TestChecklist
Management
Report
Plan
User
Requiremen
t
Specificatio
n
Risk
Manageme
nt Plan
Supplier
Audit
Functional
Requiremen
t
Specificatio
n
Design
Requiremen
t
Specificatio
n
Installation
Qualificatio
n Protocols
Operational
Qualificatio
n Protocols
Trace
Matrix
Performanc
e
12
Qualificatio
n Protocols
Sample
Usage SOPs
Final
Validation
Report
Practical Requirements
Process Control Systems
Distributed Control Systems
Programmable Logic Controllers
SCADA / BMS
14
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
15
Laboratory Computerized Systems
Office computer
Server
e.g., for printing and
archiving
Programmable instruments
Instrument Software
HPLC, GC, FTIR etc
Stability Cambers, Incubators
16
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
17
Global Information Systems
Enterprise Resource Planning Systems
SAP, Other ERP Packages
Document Management Systems
18
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
19
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
20
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
21
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
Questions & Comments
Thank You For Your Attention
Sincerely Yours
