We deliver Dynamics 365 to pharma, biotech, medical device, and CDMO companies — with computer system validation built into the implementation, not bolted on after.
Standard ERP partners deliver a working system, then hand it off. The Computer System Validation work — the URS, the traceability matrix, the IQ/OQ/PQ protocols, the validation summary — happens later, with a different team, often a different vendor. The seams show. Auditors find them.
That's the gap Aperigon was built to close. We deliver the implementation and the validation as one project, with one senior team, producing one coherent set of artifacts. Your auditor reads the same documents your configurators wrote.
CSV deliverables are produced by the implementation team as part of the implementation. URS, FRS, configuration spec, traceability matrix, IQ/OQ/PQ protocols, validation summary report — written as we build, not after.
Lot and serial traceability, EBR/eBPR integration patterns, QMS integration, regulated document handling, electronic signatures and audit trails configured to 21 CFR Part 11 and EU Annex 11 — out of the box from us.
Phases are scoped around named deliverables and written acceptance criteria. If a phase misses its acceptance criteria, we own the gap.
We work with pharma, biotech, medical device, and CDMO/CMO companies that are either replacing entry-level ERP (QuickBooks, NetSuite, Sage) or implementing ERP for the first time as they move toward commercial operations.
A few situations we know well:
Three things happened in the last twelve months that change how Life Sciences companies should be thinking about ERP validation:
Full-lifecycle Dynamics 365: Finance, Supply Chain, Manufacturing, Project Accounting.
CSV for 21 CFR Part 11, EU Annex 11, and GAMP 5 — risk-based, CSA-aligned.
Lot/serial traceability, EBR/eBPR integration, QMS integration, regulated documents.
Post-go-live support, release management, regulatory change response.
Five phases. Each one produces named deliverables that map directly to validation evidence.
URS, risk assessment, validation plan.
FRS, configuration spec, traceability matrix v1.
Configuration, integration, IQ.
OQ, PQ, user acceptance.
VSR, training, go-live, hypercare.
We respond to every inbound personally, usually within a business day. No SDR queue. No discovery-call carousel. If we're not the right fit, we'll say so.