COMPUTER SYSTEM VALIDATION AS PER GAMP 5 GUIDELINE

VALIDATION CONCEPT

Computerized systems validation: Means confirmation by examination and provision of objective evidence that computer system specifications conform to user needs and intended uses and that all requirements can be consistently fulfilled.

Computerized systems should be maintained in the validated state with risk-based controls appropriate to the different stages of the system life cycle. These stages include system planning, specification, programming and configuration, system testing, preparation and verification of standard operating procedures (SOPs) and training programe, system operation and maintenance including handling of software and hardware updates, monitoring and review, followed by system retirement.

PROPOSAL

Computer System validation of pharmaceutical application will be done as per GAMP 5 Guideline.

Validation documents preparation with respect to 21 CFR Part 11 and Annexure 11.

Maintain Validation Flow…

Validation Document prepared in stipulated timeline.

Execution will be perform by providing VPN.

Validation Document preparation as per following...

CONCEPT PHASE

Initiate Change control or other QMS documents as per site requirement.

PROJECT PHASE

Preparation of High level risk assessment (GxP and Computerized system Assessment & System classification as per USP classification).

Preparation of User requirement Specification.

Preparation of Vendor Assessment.

Preparation of Validation Project Plan.

Preparation of Configuration Specification.

OPERATION PHASE

Preparation of Installation Qualification Protocol (Self Executed).

Preparation of Operation Qualification Protocol (Self Executed).

Preparation of Performance Qualification Protocol (Self Executed).

Preparation of Risk Assessment.

Preparation of Trace ability Matrix.

Preparation of Validation Summary Report.

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