21 CFR Part 110 - 117 Food GMPs

21 CFR Part 111 Dietary Supplement

21 CFR Parts 210/211 Drug GMPs

21 CFR Part 820 QSRs - Device

Biologics - Clinical - CMOs, CAOs...

English / Español CAPA Managers Available

US FDA / EU CAPA Solution - 21 CFR Part 11 Compliant

CAPA Manager

The Validation Process

Full Software and Systems Validation - GAMP 5

Design Qualifications (DQ) - Hardware and Software - On-site review available upon request

Installation Qualifications (IQ) - On-site review available upon request

Operational Qualifications (OQ) - On-site review available upon request

Performance Qualifications (PQ) - Kits available for each annual purchase