Our Validation Approach

Validation is often cited as the main brake on digitizing quality operations, yet the FDA's 2022 CSA guidance and the second edition of GAMP 5 point toward a lighter, risk-based model. This brochure sets out one vendor's interpretation, from its GAMP Category 4 placement to the split of responsibilities between supplier and customer. It follows the process from supplier qualification through configuration, the validation summary report, and re-assurance as the software changes. It also features comments from GAMP 5 editor Sion Wyn, perspective from Kelly Stanton, Director of Quality at Qualio, and an FAQ that takes on the question of why IQ, OQ, and PQ documents are absent.

Gain insight into the approach and judge how it compares with your current practice.