Contract manufacturing software built for CDMOs and CMOs — not adapted for them.
V5 Ultimate is the platform CDMOs and CMOs pick when every client wants their own batch record, their own CoA template, their own retention rules and their own portal — and none of them want to see each other. Multi-client isolation, per-client audit trails, tech-transfer as workflow, one signed record per batch.
You searched contract manufacturing software because the current stack was never built for a CMO.
Every client wants their own batch record layout — you're maintaining 40 Word templates
One MES per client is impossible; one MES shared across clients leaks data at audit
CoAs are re-typed into each client's format — a full-time job and a data-integrity risk
Tech-transfer from client R&D is a 6-month email thread and a shared drive
Client audits require you to hand-carve their data out of a mixed system
Retention and destruction rules differ per client and nobody tracks them
The controls a CDMO actually needs to run 40 clients on one platform.
Per-client data isolation
Client-scoped batch records, materials, CoAs, deviations, CAPAs and audit trails — enforced at row level, verifiable at inspection. One client's auditor sees only that client's data, cleanly extracted.
Per-client batch record & CoA templates
Each client gets their branded MBR / eBR layout and their CoA format — all driven by the same underlying execution engine. Templates are configuration, not custom code.
Tech-transfer as workflow
R&D specifications, method transfer, engineering runs, PPQ, first commercial — modelled as a staged workflow with deliverables, sign-offs and change-control per client, not a shared drive.
Client portal (read-only)
Give each client scoped, read-only visibility into their in-flight batches, released CoAs, deviations and CAPAs — retire the weekly status call and the email attachment.
Per-client retention & destruction
MSA-driven retention rules per client (7 years, 25 years, indefinite), automatic legal-hold, evidenced destruction — provable per client at audit.
Per-client audit surface
Client audit → filter the entire system to that client → export a scoped, timestamped, signed evidence pack. No manual carve-out, no accidental cross-client disclosure.
What changes the day this goes live.
- Client onboarding drops from 3-6 months to 2-4 weeks — templates are configuration, not code
- Client audits get through the data request in one afternoon, not one week
- CoA re-typing disappears — client-formatted CoA is generated from the batch record
- Tech-transfer from client R&D becomes a tracked workflow with a delivery date
- The client portal replaces the weekly status call and half the sponsor email traffic
Contract manufacturing that carries pharma-grade weight per client.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — covered out of the box.
GAMP 5 Second Edition
Category 4 configured product with documented critical thinking. CSA-aligned test evidence delivered with onboarding — not a six-month after-the-fact project.
See the device-CMO view — eDHR per client, ISO 13485 and 21 CFR 820.
Contract manufacturing software, answered.
How does V5 isolate one client's data from another's?
V5 enforces client scope at row level — every batch, material, deviation, CAPA and audit-trail entry is stamped with the owning client. Users are scoped to the clients they support; a client's own auditor is scoped to that client only. The isolation is provable — you can hand an auditor the SQL and the RLS policies as evidence.
Can each client have their own batch record layout?
Yes. The batch record layout, the sections, the in-process checks and the CoA are per-client templates — all driven by the same underlying execution engine. Adding a new client is template configuration, not a code branch.
How does the client portal work?
Each client gets a scoped, read-only login into V5 that shows their in-flight batches, released CoAs, open deviations and open CAPAs. All portal actions are audit-trailed. It replaces the sponsor status call and the weekly PDF pack.
Does V5 support tech-transfer from a client's R&D group?
Yes. Tech-transfer is a modelled workflow: master formula / master batch record intake from client R&D, gap analysis, method transfer, engineering / demonstration runs, PPQ, first commercial. Each stage has deliverables, sign-offs and change-control scoped to that client.
How is V5 licensed for a CDMO — per client or per plant?
V5 is licensed by plant / site, not per client. Onboarding a new client is a template + user-scope change, not a new subscription — the economics scale with your book of business, not with the number of client logos on it.
Run 40 clients on one platform. Prove isolation at every audit.
Free trial. Real client isolation. First per-client batch record in 30 days.