FDA 21 CFR Part 11 Validation

Compliance with FDA 21 CFR Part 11 regulations requires the FDA 21 CFR Part 11 validation of a company's electronic quality management system.

MasterControl's Quality Excellence stands as a trusted partner for FDA 21 CFR Part 11 validation, offering a suite of services and solutions that streamline compliance. Our range caters to diverse needs – from quick-start validation packages with pre-written IQ and OQ scripts, to full-cycle validation consulting encompassing user and functional requirements, supplier evaluations, and more. Beyond validation, we empower Regulatory Affairs managers with insightful documentation, navigating the intricacies of FDA 21 CFR Part 11 with confidence. Whether you seek advanced toolkits or fundamental guidance, MasterControl ensures a path to meeting GAMP-compliant computer systems validation. Simplify complexities, embrace compliant excellence, and join those who have harnessed the power of MasterControl's solutions

21 CFR Part 11: 7 Ways to Avoid Noncompliance