The challenge
The client had a fixed date for regulatory filing and a validation scope covering granulation, compression, coating, packaging, purified water, HVAC with 38 AHUs and a building management system, with limited in-house validation resources.
Our approach
We produced a risk-based validation master plan aligned to ASTM E2500 and ISPE guidance, wrote and executed DQ, IQ, OQ and PQ protocols, qualified the HVAC and cleanroom to ISO 14644, validated the BMS and packaging line PLC/SCADA under GAMP 5 and managed vendor FAT/SAT globally. A dedicated document controller maintained the traceability matrix throughout.
The outcome
The facility was qualified two weeks ahead of the filing date with a complete, audit-ready validation dossier. The client's first regulatory inspection at the site concluded without data-integrity or qualification findings.
Representative engagement. Client identity and certain project details are withheld or generalised under confidentiality agreements.