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)

"Easy setup and validation of TRINITY V3 Zone Reader"

"It has been pleasure working with the Giles Scientific sales and service team as we implemented the TRINITY V3 zone reading system for our USP antibiotic potency assays.  Their qualification documentation was very simple and straightforward, and the support we received has been great. The system was completely implemented in just a few weeks and we’ve had nothing but praise from the analysts in the lab.  The TRINITY V3 system has been very reliable and much easier to use than our old system.  We’re looking forward to many years of working with Giles Scientific."

Lab Manager
Michigan-Based Pharmaceutical Manufacturer
TRINITY V3 customer since 2009