Aperigon delivers focused Microsoft Dynamics 365 implementations with computer system validation (21 CFR Part 11 / GxP) included — so your finance, supply-chain, and quality systems are audit-ready the day you go live.
Moving from clinical to commercial, QuickBooks, spreadsheets, and disconnected point tools stop keeping up. They can't support GxP, multi-entity accounting, audits, or investor-grade reporting — and validation always seems to become a fire drill right before an inspection.
A spreadsheet-heavy month-end close and no clean, investor-ready reporting.
21 CFR Part 11 and data-integrity exposure on unvalidated systems.
No real-time view of batches, materials, chain-of-identity, and CMO hand-offs.
Carrying ERP and validation with a lean team.
Aperigon implements Microsoft Dynamics 365 (Finance & Supply Chain Management) scoped to your stage — and delivers the validation with it. One audit-ready backbone across finance, supply chain, inventory, and quality.
Fixed scope and outcome, not a multi-year program.
IQ/OQ/PQ and 21 CFR Part 11 documentation, aligned with GAMP 5 Second Edition, delivered with the system.
Batch, materials, chain-of-identity, CMO hand-offs, and grant/clinical cost tracking.
Most ERP projects hand you a system and leave validation to you or a separate vendor — so it slips, and becomes the thing that slows your next inspection. Aperigon builds validation into the delivery, aligned with GAMP 5 Second Edition, so you're audit-ready at go-live, not months after.
Fixed.
To your operating model.
IQ/OQ/PQ, Part 11, risk-based.
Cut over with confidence.
Managed services after.
Clinical-stage (Phase 1+) and early-commercial cell, gene, and genome-editing companies building or operating in-house GxP manufacturing — and outgrowing early-stage systems.
Outsourcing all manufacturing? See Asset-Light Life Sciences.
Aperigon pairs Microsoft Dynamics 365 — proven in regulated, GxP environments — with a team that has spent decades delivering validated ERP in Life Sciences, and nothing else. Senior practitioners, backed by a deep Dynamics delivery bench.