Our Approach for Computer System Validation

We Provide Following Documents as per GAMP 5 Requirements.

•   Validation Master Plan (One Time)
•   Gap Assessmet (GAP)
•   Initial Risk Assessment (IRA)
•   21CFR Part 11 compliance services (Where ever applicable)
•   User Requirement Specification (URS) If Required
•   Validation Plan (VP)
•   Functional Specification (FS) If Required
•   Design Specification (DS)If Required
•   Functional Risk Assessment Document (RA)
•   Installation Qualification (IQ)
•   Operational Qualification (OQ)
•   Performance Qualification (PQ)
•   Traceability Matrix (TM)
•   Validation Summary Report (VSR)