GMP & regulatory BIM support

Why it matters

On GMP-regulated construction projects, the quality of the project information helps determine whether a facility may go into operation. Deliveries that are untraceable, incomplete or contradictory delay qualification and put inspections at risk. Information management run rigorously to ISO 19650 ensures every model and document delivery is attributable, traceable and verifiable, in line with data integrity principles (ALCOA+). The result is validation-ready data packages that support your facility's qualification process and stand up to a regulatory inspection.

How we work

We take the ISO 19650 information management discipline we use on GMP production buildings and laboratory environments and apply it to your project's regulatory requirements: a complete audit trail through CDE and BCF workflows, structured turnover packages (COBie, asset data) and clearly defined interfaces to the qualification process (IQ/OQ/PQ). Validation itself remains with you and your validation specialists, we deliver the auditable information basis for it.

1. Capture regulatory information requirements with the client, QA and validation team
2. Classify GxP-relevant documents and model content; define responsibilities
3. Configure CDE workflows so every status transition is traceably documented (audit trail)
4. Check model and document deliveries against data integrity principles (ALCOA+)
5. Maintain an audit-ready record of BCF issues and decisions, from identification to closure
6. Align interfaces to qualification (IQ/OQ/PQ) and provide the required evidence on schedule
7. Compile structured turnover packages (COBie, asset data) for operations and inspection