Giles Scientific includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) validation documents with each TRINITY V3 purchase. These documents comply with 21 CFR Part 11 (Code of Federal Registry), Association of Analytical Communities (AOAC), Good Laboratory Practice (GLP) standards, and US-FDA Bacteriological Analytical Manual (BAM). Validation protocols may be customized to meet each laboratory's unique certification requirements.

TRINITY V3 is only system that strictly complies with 21 CFR Part 11 electronic signature requirements from reading test plates to reporting test results. Learn more

Additional information available below:

21 CFR Part 11 (Code of Federal Registry)

Association of Analytical Communities (AOAC)

Good Laboratory Practice (GLP)

US-FDA Bacteriological Analytical Manual (BAM)