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GAMP 5 Guidelines for Computerized System Validation


Computerized System

A broad range of systems including, but not limited to – 

  • automated manufacturing equipment, 
  • automated laboratory equipment, 
  • process control and process analytical, 
  • manufacturing execution, 
  • laboratory information management, 
  • manufacturing resource planning, 
  • clinical trials data management, 
  • vigilance and document management systems.

The computerized system consists of hardware, software, and network components, together with the controlled functions and associated documentation.

Computerized System Validation (CSV)

Achieving and maintaining compliance with applicable GxP regulations and fitness for intended use by:

  • the adoption of principles, approaches, and life cycle activities within the framework of validation plans and reports
  • the application of appropriate operational controls throughout the life cycle of the system

Where a computer system is regarded as one component of a wider manufacturing process or system, particularly in integrated quality by design environment, specific and separate computerized system validation may not be necessary. This environment requires both complete product and process understanding and that the critical process parameters can be accurately and reliably predicted and controlled over the design space. Where subsequent process validation or continuous quality verification of the overall process or system can apply.

Computerized System Validation Framework

Traditionally GAMP has advocated a computerized system validation framework to achieve and maintain GxP compliance throughout the computerized system life cycle.

This framework is based on system specific validation plans and reports and the application of appropriate operational controls. Validation plans and reports provide a disciplined and consistent approach to meeting regulatory requirements, leading to appropriate documentation at the right level. Such documents are valuable both in preparing for, and during, regulatory inspections. 

This framework is still applicable for the majority of computerized systems in pharmaceutical industry. 

Validation Planning and Reporting

Computer system specification and verification should be part of an integrated engineering approach to ensure compliance and fitness for intended use of the complete automated equipment.

Regulated pharma companies should have corporate or site level policy documents that define their overall approach to computerized system quality and compliance. Such documents should define, or make reference to, the following – 

  • roles and responsibilities for activities and support,
  • high level expectations for deliverables,
  • standards, templates and procedures that are expected to be followed throughout the organizations,
  • definition of high level processes, including the process to determine whether a system is GxP regulated,
  • requirements for management of documentation.

This policies should be readily available to all those with responsibilities for verification and validation activities, and should be referred to by relevant planning documents.

Where required by a computerized system validation plan, a validation report should be produced, focusing on the aspects related to patient safety, product quality, and data integrity. It should summarize the activities performed, any deviation from the validation plan, any outstanding and corrective actions, and a statement of fitness for intended use of the system.

The quality unit is responsible for ensuring that the generated documents comply with requirements specified in the corresponding plan, are produced in line with company policies and procedures, and meet the appropriate regulatory requirements.

Contents of the Computerized System Validation Report

  • Introduction and Scope
  • Scope Changes
  • Supplier Assessment
  • Summary of Activities
  • Summary of Deliverables
  • Summary of Deviations and Corrective Actions
  • Statement of Fitness for Intended Use
  • Training
  • Maintaining Compliance and Fitness for Intended Use
  • Glossary
  • Appendices

Read Also: Introduction to ISPE GAMP 5 Guide

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