BMS unification for pharma R&D campus — Helix Sciences

Client: Major UK pharmaceutical organisation (anonymised at the client's request)

The brief

A pharma R&D campus had grown five distinct BMS estates across labs commissioned at different times under different validation regimes. GMP audits had to be conducted per-estate; the audit-trail mismatch between systems was a standing finding.

Our scope

• Validation-aligned audit of the five estates against GAMP 5 and 21 CFR Part 11.
• iBMS overlay specification with full traceability of point mastership and change history.
• Environmental Monitoring System (EMS) integration into the iBMS so excursions surface in one queue.
• Re-validation of the converged operation with the client's quality team.

Outcome

Single GMP audit envelope across the campus. Excursion response time down by 60%. Change-control discipline now lives in the iBMS layer, not in five parallel systems.