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

Materials Systems

Production Systems

Packaging & Labeling 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

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 1 2 3 4 Software Type Operating System Firmware Standard Software Packages Configurable Software Packages Low Removed in GAMP 5 Medium - High Medium - High CSV Criticality

Custom or Bespoke Systems

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
Validation Documentation Validation Plan
Validation Validation Planning Checklist Planning Risk Risk Management Plan Manageme

System Usage SOPs

User Training

Go Live!

System Maintenance

Training Records

Custom Monitoring Program Corrective / Preventative Action

Supplier Audit

Checklist

nt Plan

Supplier Audit

Validation Review

Final Validation Report

Updated Risk Management Plan

User Functional Design Requiremen User Requiremen Requiremen PQ Protocols Requirements t t t Acceptance Sample System Usage Usage Specification Specificatio UserSpecificatio Specificatio Criteria SOPs SOPs n n n Installation Functional Requirements Qualificatio Specification n Protocols Operational Qualificatio OQ Protocols n Protocols
Trace Matrix

Protocol Test Records

PQ Testing

PQ Test Report

Updated Risk Management Plan

Trace Matrix

Protocol Test Records

OQ Testing

Performanc Final e Design Sample Validation Requirements IQ Testing Qualificatio Usage SOPs IQ Protocols Report Specification HW /SW n Protocols
Requirements

Protocol Test Records

Validation Planning Updated Risk IQ / OQ TestChecklist Management Report Plan User Requiremen t Specificatio n Installation Qualificatio n Protocols Performanc e 12 Qualificatio n Protocols

Risk Manageme nt Plan Functional Requiremen t Specificatio n Operational Qualificatio n Protocols Sample Usage SOPs

Supplier Audit Design Requiremen t Specificatio n Trace Matrix Final Validation Report

Off the Shelf SOFTWARE

Customer Installation & Configuration

Configuration Drawing

Updated Risk Management Plan

SysAdmin Training

Configuration Homework Training Records

Practical Requirements

Process Control Systems

Distributed Control Systems Programmable Logic Controllers SCADA / BMS

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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

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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

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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

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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