Quality Management Software for Life Sciences | Kintavo
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Life Sciences

An umbrella platform for research, translational, and clinical-stage life-sciences organizations operating under GxP.

GxP 21 CFR 11 EU Annex 11
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THE PROBLEM

The Quality System That Got You Here Won't Survive Your First Inspection.

Most life-sciences companies assemble quality ad hoc as they grow: a shared drive at the research stage, a spreadsheet when GLP arrives, a binder when the first sponsor audit is announced. It works — until the program succeeds. Then the same records that were good enough for ten people become the evidence base for an IND, a BLA, or a partner's due diligence.

The usual answer is re-platforming at every phase — new tool, new migration, new gaps — while the quality team of one or two carries the institutional memory in their heads. That is the risk an inspector finds first.

REGULATORY REQUIREMENTS

What GxP Requires as Your Program Moves From Bench to Clinic

The umbrella widens at every phase. GLP (21 CFR 58) requires controlled protocols, trained personnel, and traceable study records. GCP (ICH E6) adds sponsor oversight, CRO qualification, and protocol-deviation management. As manufacturing approaches, GMP expectations arrive — and across all of it, Part 11 and EU Annex 11 govern every electronic record and signature.

Kintavo runs the set as one system from the start: the controlled documents, training chains, and audit trails you build at GLP carry forward to GCP and GMP instead of being rebuilt at each gate.

WHAT AUDITORS LOOK FOR
Official records living in shared spreadsheets with no Part 11 controls — attributable to no one.
SOPs that lag actual practice because processes changed faster than the documents.
Training records that do not match current protocols, roles, or document revisions.
CRO and vendor work with no documented qualification or oversight trail.
WHAT KINTAVO REPLACES
SOPs on a research wiki or shared drive → One controlled library with versioned, signed approvals
Training tracked in a spreadsheet → Assignments triggered by document changes, tracked to completion
Deviations handled over email → Structured events with root cause, CAPA linkage, and trends
A new point tool at every phase → One platform that scales from GLP through GCP to GMP
The pre-audit binder scramble → Inspection-ready as the steady state, evidence one click away
CORE CAPABILITIES

One Quality System, From First Study to First Batch.

Document Control
Versioned SOPs and protocols with Part 11 e-signatures — controlled from the first GLP study onward.
Training Management
Role-based curricula that reassign themselves when documents change, so the matrix matches reality.
Deviation Management
Protocol deviations and quality events captured in minutes, triaged by risk, driven to closure.
Risk Management
ICH Q9-aligned registers that grow with the program — fed by real events, not annual reviews.
Change Control
Process and document changes assessed for impact across studies, training, and validation before approval.
AI Smart Assist™
Plain-language answers across every record — the institutional memory a three-person quality team doesn't have time to be.
WHAT IT LOOKS LIKE IN PRACTICE

A Series B biotech, eight months from IND, quality team of two. Kintavo goes live in seven weeks: the SOP library migrates with its history, training chains attach to every protocol, and CRO qualification moves out of email. When the sponsor's auditors arrive, the answer to every request is a record — authored, signed, dated — not a reconstruction. The finding count: zero. The quality lead's weekend: intact.

Configured for your rules from day one.

GXP
GxP from research to clinic
One system that grows with you from GLP studies through GCP trials — no re-platforming at each phase.
PART 11
Part 11 & Annex 11 native
E-signatures, audit trails, and access control built in — validation documentation included.
SPEED
Weeks to live, not quarters
Clinical-stage timelines don't wait for a 9-month eQMS rollout. Neither do we.
“
"Employees praised Kintavo's intuitive design, flexibility, simplicity, and the support received from the team."
MD Anderson Cancer Center Houston, TX
MOST USED BY LIFE SCIENCES TEAMS
Document Control → Training Management → Risk Management → Change Control → AI Smart Assist™ →
QUESTIONS & ANSWERS

Life Sciences FAQ

Do we need an eQMS at the preclinical stage?
You need controlled documents, training records, and event capture the day your data supports a filing. Starting early costs weeks; retrofitting a paper system at IND costs quarters — and findings.
Is Kintavo 21 CFR Part 11 compliant for a clinical-stage company?
Yes. E-signatures, immutable audit trails, and access controls are built in, and IQ/OQ/PQ validation documentation ships with every plan — sized for a small quality team, not an enterprise rollout.
Can the same system carry us from GLP through GCP to GMP?
Yes. Modules activate as your program matures — the records, training history, and audit trail carry forward instead of migrating between point tools at each phase.
How fast can a two-person quality team go live?
Live in 8–12 weeks, with the validation package delivered as part of implementation. Implementation is guided — document migration, workflow configuration, and role-based training are part of every plan.

See Kintavo configured for life sciences.

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

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