Aperigon implements Microsoft Dynamics 365 for contract manufacturers — with computer system validation (21 CFR Part 11 / GxP) included. One audit-ready backbone your clients can trust and your acquired sites can share.
Growth makes the systems problem worse, not better. Each client program brings its own specs, batch records, and quality agreement. Each acquired site arrives on its own ERP. And every client — plus every regulator — expects Part 11-compliant records and a facility that can pass an audit on demand.
Consolidating multiple entities and sites after a roll-up, with no clean per-client, per-program margin view.
Segregated, Part 11-compliant batch records and quality agreements across every client — and surviving back-to-back client audits.
Planning capacity and scheduling across lines and sites, running tech transfers, and hitting right-first-time and on-time-in-full.
A patchwork of ERPs inherited from acquisitions, carrying integration and validation with a lean team.
Aperigon implements Microsoft Dynamics 365 (Finance & Supply Chain Management) as a single system of record across your sites — with client-level segregation, program costing, and the validation delivered with it. Bring acquired facilities onto one audit-ready platform instead of maintaining five.
Segregated records, per-client specs and quality agreements, program-level costing and margin.
IQ/OQ/PQ and 21 CFR Part 11 documentation, aligned with GAMP 5 Second Edition, delivered with the system — audit-ready for you and your clients.
Capacity planning and scheduling, tech transfer, lot/serial traceability, and client-facing batch records.
For most ERP vendors, validation is your problem after go-live — which means it's also the exposure a client's audit team finds first. Aperigon builds validation into delivery, aligned with GAMP 5 Second Edition and Part 11-ready at go-live. That turns your system of record from an audit liability into something you put in front of prospects.
Fixed, per-site rollout plan.
To your client and quality model.
IQ/OQ/PQ, Part 11, risk-based.
Site by site.
Managed services after.
Life Sciences CDMOs and CMOs — biologics, sterile fill-finish, OSD, cell & gene, API — consolidating acquired sites, taking on larger and more regulated client programs, or replacing systems that can't pass a modern data-integrity audit.
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 that can carry a multi-site rollout.