Quality software for CMOs & CDMOs — built multi-sponsor from day one.
Sponsors don't only audit your facility — they audit your system. V5 was built multi-tenant from day one: row-level sponsor segregation on every batch, sponsor-portal visibility, per-sponsor change-control branching, and audit packs you can hand to the sponsor's QA in hours, not weeks.
What breaks without this.
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.
Records-by-execution. Compliance, by design.
Row-level sponsor segregation on every record
Every batch, deviation, CAPA, change and training record is tagged to a sponsor. Sponsor A cannot see sponsor B's recipe, yield, or operator notes — even when both ran tank 4 last week.
Sponsor portal — real-time, read-only, watermarked
Each sponsor sees their own batches, deviations, CAPAs and training rosters in real time. CMO-internal data is redacted automatically. Sponsor audits shrink from a week to an afternoon.
Per-sponsor change-control branching
One change request fans out to sponsor-specific approval paths driven by each quality agreement. The change goes live only when every sponsor obligation is met.
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 roll the validated config to production without re-coding.
Audit pack in one click
Select sponsor → date range → product → click. Out comes the batch record, deviations, CAPAs, training, change controls and supplier evidence — for that sponsor only, time-bounded, watermarked.
What to look for when you're buying.
CMO/CDMO software must serve two masters — your ops and each sponsor's QA. Multi-tenancy at the data layer is the difference.
Row-level sponsor segregation
What it tests: Is every batch, record and document tagged and enforced by sponsor at the row level?
Why it matters: Cross-sponsor leakage is an existential audit risk.
V5: Row-level tags with policy enforcement; verified in a signed segregation test.
Sponsor portal
What it tests: Do sponsors see their own records live, not via emailed PDFs?
Why it matters: Sponsor QA and TS want visibility, not a lag.
V5: Native portal per sponsor with scoped visibility.
Per-sponsor change control
What it tests: Can changes be scoped per sponsor and require sponsor approval?
Why it matters: Sponsors own their process; change without approval breaks the MSA.
V5: Change branch per sponsor with sponsor approval gate.
Sponsor audit packs
What it tests: Can each sponsor's audit pack be produced in hours?
Why it matters: Sponsor audits are constant; assembly cost adds up.
V5: Per-sponsor pack export ships with the platform.
MSA-mapped QAA support
What it tests: Are MSA/QAA quality obligations mapped to system controls?
Why it matters: Deviations from QAA are contractual risk.
V5: QAA obligations expressed as system rules; deviations surfaced.
Spreadsheet vs legacy QMS vs V5.
How V5 CMO/CDMO stacks up.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| Row-level segregation | Folder | Tenant hack | Native row-level |
| Sponsor portal | Custom build | Native | |
| Per-sponsor change | None | Manual branching | First-class |
| Audit pack per sponsor | Days | Consultant | Hours |
The clauses, verbatim — and how V5 answers each.
Cross-cutting CMO clauses.
The pharmaceutical quality system... should include appropriate processes... for outsourced activities.
V5: Outsourced activity is a controlled sponsor-scoped process in V5.
Contract manufacture and analysis must be correctly defined, agreed and controlled...
V5: QAA obligations expressed as rules; adherence trended.
Contract facilities... are considered part of the manufacturer's facility.
V5: Sponsor audit posture is your audit posture — served via portal.
Step by step on the floor.
V5 for CMOs runs one platform many sponsors.
- 1Onboard
Sponsor scope created
Tenant + portal + QAA rules created in one step.
- 2Make
Batches segregated
Row-level tags carry through eBR, QMS, warehouse.
- 3Change
Sponsor approval gate
Changes route to sponsor QA for approval.
- 4Audit
Sponsor pack in hours
Sponsor QA receives a signed audit pack on demand.
The math, with the assumptions visible.
CMO ROI is measured in audit prep and sponsor onboarding time.
Sponsor onboarding
Templated tenant + portal + QAA rules.
Sponsor audit prep
Signed pack export.
Cross-sponsor leakage risk
Row-level policy.
Most CMOs recover V5 cost in one sponsor onboarding avoided.
What changed on the floor.
Setting
A CDMO with 14 sponsors across two sites.
Before
Sponsor audits averaged 2 weeks prep each; occasional folder-mix incidents.
After
Prep is under a day per audit; folder-mix incidents structurally impossible.
Proof points
- One V5 plant hosts dozens of sponsors without copy-paste segregation
- Sponsor-portal access typically cuts on-site audit duration in half
- Audit-prep time: 1–2 weeks → under 4 hours
- Tech transfer: 6–10 weeks signature → live engineering batch
- ICH Q10 PQS, ICH Q9 risk-based change control, 21 CFR Part 11 e-sig end-to-end
Built to satisfy
- 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)
Frequently asked questions
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. Multi-tenant from the start costs no more and removes the cap on growth.
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.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.