Regulogix Solutions focus on implementing internationally accepted GAMP 5 guidelines and its current interpretations for validation of computerized systems applying Risk Based Approach and Life Cycle Management Philosophy.
The Computerized System Validation services include: ERP Systems Laboratory Computerized Systems Process Control Systems Infrastructure Qualification Clinical Trial Applications/Statistical Softwares/Pharmacokinetic Applications 21 CFR Part 11 System Assessment and GAP Analysis
Computerized System Validation Deliverables Validation Master Plan Risk Assessment Plan and Report User Requirement specification Functional Specification Design Specification Network/ Infrastructure Qualification Protocol and Report Installation Qualification (IQ) Protocol and Report Operation Qualification (OQ) Protocol and Report Performance Qualification (PQ) Protocol and Report Validation Summary Report Traceability Matrix Assessment for compliance with regulations pertaining to electronic records and signatures (e.g., 21 CFR Part 11) Supplier Assessment Report Periodic Review Report