21 CFR part 11 Documentation & Validation

We provide FDA validation service for 21 CFR part 11 documentation & system engineering as per GAMP regulations. The following attributes are engineered and documented for implementation of “21 CFR Part 11” compliant system.

• Audit Trail
• Electronic Record
• Access Security
• Archiving and Retrieval
• Validation Documentation(FDS,DQ,OQ,IQ)
• FDS-Functional Design Specification.
• DQ-Design Qualification.
• IQ-Installation Qualification .
• OQ-Operational Qualification.