eQMS for CDMOs | Kintavo
DEVELOPMENT, MANUFACTURING & COMMERCIALIZATION

CDMOs

Multi-client, multi-product quality systems for contract development & manufacturing — with sponsor-isolated data and reporting.

Multi-client Tech transfer GMP
Book a demo for CDMOs ← All industries
THE PROBLEM

Every Client Audits You. Every Client Sees a Different Slice. The System Is One.

A CDMO’s quality system serves two masters per client: the regulator and the sponsor. Twenty clients means twenty quality agreements with different notification clauses, twenty audit schedules, and twenty definitions of "major deviation" — running on one floor, one staff, one system. Spreadsheets fracture immediately under that load; most eQMS platforms handle it with duplicated sites and duplicated cost.

The commercial stakes compound the regulatory ones: audit performance is sales performance. A client auditor who waits two days for records draws conclusions about your operation that no BD deck can undo.

REGULATORY REQUIREMENTS

What GMP, ICH Q10, and Quality Agreements Require From Contract Quality

The GMP burden is undiminished by the contract: Part 211 and EU GMP apply to the site doing the work. ICH Q10 and chapter 7 place outsourced-activity oversight on both parties — meaning your system must produce the reviews, notifications, and metrics each quality agreement promises. And each sponsor’s auditors test whether your one system honors their specific terms.

Kintavo runs multi-client quality natively: records tagged to client and product, quality-agreement terms as workflow rules, and sponsor portal views that show each client everything of theirs and nothing of anyone else’s.

WHAT AUDITORS LOOK FOR
Deviation notifications sent outside the quality-agreement window — per-client clocks nobody tracked.
Client audit responses assembled slowly from a shared system nobody dares open in front of them.
Change notifications missed because the change record did not know which clients it touched.
Cross-contamination of client data in reports — the confidentiality finding.
WHAT KINTAVO REPLACES
One spreadsheet per client → One system, client-partitioned by design
Quality agreements in a drawer → Agreement terms as enforced workflow rules
Notification clocks in memory → Per-client timelines tracked and escalated
Client audits as fire drills → Sponsor-scoped evidence, retrievable in the room
Tech transfer by binder → Transfer packages as controlled, linked records
CORE CAPABILITIES

One System. Twenty Clients. Zero Bleed.

Client-Partitioned Records
Every record carries its client and product; views, reports, and exports scope automatically.
Quality Agreement Enforcement
Notification windows, approval rights, and definitions per client — as workflow rules, not institutional memory.
Per-Client Deviation Clocks
A major deviation for client A starts client A’s notification timer — tracked, escalated, evidenced.
Sponsor Audit Mode
Client auditors see their slice, live — requests logged, evidence scoped, follow-ups assigned in the room.
Tech Transfer Records
Transfer protocols, gaps, and verification as linked records from feasibility to first GMP batch.
Client Quality Metrics
The quarterly review packet per sponsor — deviations, CAPAs, changes, on-time performance — generated, not assembled.
WHAT IT LOOKS LIKE IN PRACTICE

A sponsor auditor arrives for a scheduled audit. Her view: her products, her deviations, her changes — nothing else exists. She samples a deviation; the record shows her quality agreement’s 48-hour notification, sent at hour 31, with the acknowledgment attached. The audit closes in one day with zero findings and one comment: "best-organized contract quality system we’ve audited this year." BD asks for that sentence in writing.

EVIDENCE, NOT CLAIMS

The Client Auditor Sees Everything Theirs. Nothing Else.

Sponsor-scoped views make the confidentiality boundary structural: one system of record, per-client windows onto it, every access logged. Audit day stops being a risk to the other twenty relationships.

Signed approval chain on a controlled record — the audit trail a client auditor samples
SHOWN WITH SAMPLE DATA. YOUR NUMBERS APPEAR THE DAY YOU CONNECT YOUR SYSTEM.

Configured for your rules from day one.

ISOLATION
Sponsor-isolated data
Each client sees their records and only their records — with clean reporting for sponsor audits.
TRANSFER
Tech transfer without loss
Methods, specs, and training move between sites with their history and approvals intact.
AUDITS
Client audits on repeat
When every quarter brings a sponsor audit, inspection-readiness has to be the default state.
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"It was a no-brainer for us to implement Kintavo."
National Blood Collaborative Blood solutions · Trusted shared
MOST USED BY CDMOS TEAMS
Document Control → Change Control → Supplier Quality → Audit Management → Training Management →
QUESTIONS & ANSWERS

CDMOs FAQ

How does sponsor data isolation actually work?
Every record is tagged to client and product at creation; role-based views scope everything — screens, reports, exports, audit mode — to that tag. Isolation is structural, and every access is logged.
Can quality agreement terms be enforced, not just filed?
Yes — notification windows, approval rights, and severity definitions configure per client and drive the workflows. The agreement stops being a document and becomes behavior.
Can clients have direct portal access?
If you choose — read-only sponsor views scoped to their records, commonly used for deviations pending their approval and quarterly metrics.
How does Kintavo handle tech transfers?
Transfer protocols, gap assessments, and verification runs live as linked records, so the path from feasibility to first GMP batch is documented as it happens.

See Kintavo configured for CDMOs.

Bring your real pain points. We'll show you exactly how it solves them — in your regulatory language.

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