Contract manufacturing · CMO · CDMO
Quality software for CMOs and CDMOs serving several clients.
Keep each client's batches, documents and changes organised and share agreed records through a portal.
Sponsor portal — real-time, read-only, watermarked
Each sponsor sees their own batches, deviations, CAPAs and training rosters in real time.
Per-Sponsor Change-Control Branching
One change request fans out to sponsor-specific approval paths driven by each quality agreement.
Tech-transfer mode that doesn't slip
Import the sponsor's MMR into a structured BOM + SOP package, assign and verify operator training, run engineering batches in the live system, and…
What goes wrong today4 common problems
Single-Tenant QMS Forces Ugly Multi-Sponsor Workarounds
Separate instances, tagged exports, manual redaction — every new sponsor makes the system worse, not better.
Sponsor Audits Eat a Week of QA Every Time
Printing binders, chasing sign-offs and redacting PDFs is the symptom of a system that lives on file shares.
Change Control on Email Misses Sponsor Obligations
One site change can be a notification for sponsor A and a formal approval for sponsor B — miss it and you've breached the quality agreement.
Tech Transfers Slip 4–8 Weeks on Spreadsheets
BD wins on the tour; ops loses on the transfer. The first six weeks decide whether the anchor sticks.
How it works, step by step4 steps
V5 for CMOs runs one platform many sponsors.
- Sponsor Scope Created. Tenant + portal + QAA rules created in one step.
- Sponsor Approval Gate. Changes route to sponsor QA for approval.
- Sponsor Pack in Hours. Sponsor QA receives a signed audit pack on demand.
What to look for when choosing
CMO/CDMO software must serve two masters — your ops and each sponsor's QA. Multi-tenancy at the data layer is the difference.
Sponsor Portal
Do sponsors see their own records live, not via emailed PDFs? Native portal per sponsor with scoped visibility.
Per-Sponsor Change Control
Can changes be scoped per sponsor and require sponsor approval? Change branch per sponsor with sponsor approval gate.
Sponsor Audit Packs
Can each sponsor's audit pack be produced in hours? Per-sponsor pack export ships with the platform.
MSA-Mapped QAA Support
Are MSA/QAA quality obligations mapped to system controls? QAA obligations expressed as system rules; deviations surfaced.
V5 Compared with Other Approaches
How V5 CMO/CDMO stacks up.
| capability | spreadsheet | legacy Qms | v5 |
|---|---|---|---|
| Folder | Tenant hack | ||
| Sponsor portal | Custom build | Native | |
| Per-sponsor change | None | Manual branching | First-class |
| Audit pack per sponsor | Days | Consultant | Hours |
Regulations this supportsYour quality team stays responsible for compliance
Cross-cutting CMO clauses.
ICH Q10 §2.7
Outsourced activity is a controlled sponsor-scoped process in V5.
EU GMP Chapter 7
QAA obligations expressed as rules; adherence trended.
21 CFR 200.10
Sponsor audit posture is your audit posture — served via portal.
Standards Referenced
- ICH Q10 (Pharmaceutical Quality System)
- ICH Q9 (Quality Risk Management)
- ICH Q7 (GMP for active pharmaceutical ingredients)
- 21 CFR 211 (Pharma GMP)
- 21 CFR Part 11 (Electronic records & signatures)
- EU GMP Annex 11 + Annex 16 (computerised systems, QP release)
Common questions4 answers
- We have one anchor client. Do we really need multi-tenant features?
- Today, no — tomorrow, every BD win raises the question. Most CMOs make this software decision exactly once, and the second sponsor is when single-tenant systems start to hurt.
- How is a CDMO QMS different from a normal pharma QMS?
- Two structural differences: per-sponsor data segregation on every record, and per-sponsor quality agreements driving change control, notification and approval differently for each client. A pharma QMS designed for one sponsor cannot model either cleanly.
- Do sponsors actually use the portal?
- Yes — a sponsor with portal access typically reduces on-site audit frequency and dramatically shortens audit duration, because their QA can self-serve batch and CAPA evidence on their own product.
- Typical time-to-live for a new sponsor?
- On V5's tech-transfer mode, 6–10 weeks from contract signature to a live engineering batch. Custom-configured legacy systems typically run 16–24 weeks.