Aperigon replaces aging pharma ERP with Microsoft Dynamics 365 — multi-plant, multi-product, DSCSA-ready — and delivers the revalidation as part of the project, so modernization doesn't mean a compliance gap.
The system running your plants is expensive to maintain, hard to integrate, and increasingly hard to defend in a modern data-integrity inspection. Everyone knows it needs to be replaced. What stalls the project is the fear of revalidating a system that runs live commercial production — so the risk compounds another year.
Multi-entity, multi-plant consolidation and product-level margin on a system that's costly to keep running.
Data-integrity exposure a modern Part 11 inspection won't forgive, and recall traceability that depends on manual reconstruction.
Multi-product batch scheduling, lot and expiry control, and DSCSA serialization across plants.
A legacy ERP nearing end-of-life, expensive to maintain, and a revalidation everyone is dreading.
Aperigon replaces legacy ERP with Microsoft Dynamics 365 (Finance & Supply Chain Management) across your entities and plants — and delivers the validation with it. You get a modern, supportable platform and a clean validation package as one project, not two.
A supportable, integrated platform replacing an end-of-life system, with the audit trail intact through cutover.
IQ/OQ/PQ and 21 CFR Part 11 documentation, aligned with GAMP 5 Second Edition, delivered with the system and sized with a risk-based approach aligned with FDA CSA.
Multi-plant, multi-entity, lot/expiry traceability, DSCSA serialization, and recall readiness.
Most ERP replacements hand you a system and leave revalidation to you or a separate vendor — which is exactly why aging pharma ERPs never get replaced. Aperigon builds validation into delivery, aligned with GAMP 5 Second Edition and risk-based, so you retire the legacy system and land on a validated one in a single, controlled project.
Fixed, cutover and rollout plan.
To your plants and products.
IQ/OQ/PQ, Part 11, risk-based.
Controlled cutover.
Managed services after.
Specialty and mid-market pharma manufacturers — branded, generic, sterile injectable, OSD — that own their plants and are replacing an aging or end-of-life ERP, consolidating after M&A, or expanding capacity, and can't afford a data-integrity gap while they do it.
Aperigon pairs Microsoft Dynamics 365 — proven in regulated, GxP environments — with a team that has spent decades delivering and validating ERP in Life Sciences, and nothing else. Senior practitioners, backed by a deep Dynamics delivery bench.