V5 Ultimate
Systems & integration

CMO / CDMO management

Contract Manufacturing Organisation / Contract Development & Manufacturing Organisation · contract manufacturer · cdmo · cmo

TL;DR

Processes and systems used by a sponsor (or by the CDMO itself) to govern outsourced manufacturing, tech transfer, batch release and quality oversight.

Whether you are a sponsor outsourcing manufacture or a CDMO running other companies' products, the regulatory burden does not transfer with the work: 21 CFR 200.10 and ICH Q10 §2.7 hold both parties accountable. A Quality Agreement (FDA 2016 guidance) must define who owns release, change control, deviations, complaints, recalls and audit rights.

V5 supports multi-sponsor isolation via tenant/site architecture, sponsor-scoped data rooms, and a CDMO-mode batch record that double-signs releases (CDMO QP + sponsor QA). Tech-transfer packs (MMR, validation summary, method transfer report) ship out as a single signed bundle.

Regulatory anchors
  • 21 CFR 200.10
  • ICH Q10 §2.7
  • FDA Quality Agreement Guidance (2016)
Industries that live with this
Pharmaceutical
How V5 handles it
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Supplier portal — chase nothing. Score everything.
Suppliers log in, see what you need, submit it against your spec, and watch their scorecard. SCARs are raised, replied to and closed in the portal — not in your inbox.
Related terms
QP releaseSupplier scorecardAudit managementChange control21 CFR 21021 CFR 21121 CFR 21221 CFR 58ICH Q7ICH Q9ICH Q10ICH Q2ICH Q6GxPConditional releaseDeviationOOSOOT
Want to see CMO / CDMO management in V5?

Free trial, no credit card, onboard in days, not months.

Start freeBook a demo
Back to glossary