eQMS for Pharma & Biotech | Kintavo
DEVELOPMENT, MANUFACTURING & COMMERCIALIZATION

Pharma & Biotech

GMP-compliant quality for branded, generic, specialty pharma, and biologics — built for FDA, EMA, and PMDA scrutiny.

21 CFR 210/211 EU GMP ICH Q10
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THE PROBLEM

Mid-Size Pharma Gets Enterprise Requirements With a Fraction of the Enterprise Staff.

The regulation does not scale down. A 40-person specialty manufacturer answers to the same 211.192 investigation standard, the same data integrity guidance, and the same inspection cadence as a top-ten pharma — with a quality unit of three. Paper batch deviations, spreadsheet CAPA logs, and email change approvals are how those three keep up. Until an inspection.

The enterprise eQMS platforms priced for that reality assume an implementation team you do not have — so the status quo survives another year, and the 483 risk compounds.

REGULATORY REQUIREMENTS

What Part 211, EU GMP, and ICH Q10 Require From Your Quality System

Part 211.192 requires thorough, documented investigation of any unexplained discrepancy. Part 211.100 and 211.160 demand written procedures, followed and documented. ICH Q10 adds the system view: CAPA, change management, and management review as connected processes with metrics. EU GMP chapter 1 expects the same from any site shipping into Europe — and Annex 11 mirrors Part 11 on electronic records.

Kintavo covers the set as one platform: deviations, CAPA, change control, documents, and training on one data model, with Part 11 signatures throughout and the validation package delivered as part of implementation.

WHAT AUDITORS LOOK FOR
Investigations that restate the problem — 211.192 findings top the pharma 483 list every year.
Data integrity gaps: shared logins, batch-signed records, unreviewed audit trails.
Changes implemented before assessment — visible in the timestamps.
Training records that lag SOP revisions by months.
WHAT KINTAVO REPLACES
Paper batch deviation forms → Structured events with 211.192 investigation discipline
CAPA in a spreadsheet → Phase-gated CAPA with effectiveness verification
Change approval by email → ICH Q10 change management with impact assessment
A binder per instrument → Equipment, calibration, and PM on the asset record
Validation as your problem → IQ/OQ/PQ documentation delivered with implementation
CORE CAPABILITIES

The GMP Core, Connected.

Deviation Management
Batch-linked events with enforced timelines, structured root cause, and disposition under signature.
CAPA Management
The most-cited subsystem in FDA inspections, run as a phase-gated workflow with closure gated on verified effectiveness.
Change Control
Guided impact assessment across documents, validation, and training — approved before implemented, provably.
Document Control & Training
SOP revisions that trigger training before work proceeds under them. 211.25, operationalized.
Equipment & Calibration
Qualification, PM, and calibration on the asset — with out-of-tolerance impact assessment built in.
Audit Intelligence™
Continuous audit trail review per FDA data integrity guidance — the control most sites have on paper only.
WHAT IT LOOKS LIKE IN PRACTICE

A specialty manufacturer’s quality unit of three runs a pre-approval inspection. Every document request lands in under a minute. The investigator samples two deviations and follows one into its CAPA: root cause with evidence, actions verified, effectiveness checked against criteria at ninety days. The 483 has zero observations on the quality system — and the quality unit is still three people.

EVIDENCE, NOT CLAIMS

The Investigation Record an FDA Investigator Reads Without Questions.

Event, classification, investigation, disposition, CAPA linkage — signed, timestamped, in sequence. The record demonstrates the system; the system answers for the site.

Append-only ledger rows: timestamped operations with operator, before-and-after values, and reason
SHOWN WITH SAMPLE DATA. YOUR NUMBERS APPEAR THE DAY YOU CONNECT YOUR SYSTEM.

Configured for your rules from day one.

GMP
Batch-record-adjacent quality
Deviations, CAPAs, and change control that connect to your manufacturing reality — not a parallel universe.
GLOBAL
FDA, EMA, PMDA alignment
One quality system, audited against multiple agencies — without re-tooling between inspections.
SUPPLIERS
Supplier quality at scale
Scorecards, requalification, and supplier CAPAs for every vendor in your GMP supply chain.
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"Employees praised Kintavo's intuitive design, flexibility, simplicity, and the support received from the team."
MD Anderson Cancer Center Houston, TX
MOST USED BY PHARMA & BIOTECH TEAMS
Deviation Management → CAPA Management → Change Control → Supplier Quality → Risk Management →
QUESTIONS & ANSWERS

Pharma & Biotech FAQ

Is Kintavo validated for GMP use?
The platform carries vendor validation, and your configuration is covered by an IQ/OQ/PQ package written, executed, and delivered by Kintavo as part of every implementation. Your team reviews and signs.
How does Kintavo handle EU GMP alongside FDA requirements?
One system, both frameworks: Part 11 and Annex 11 electronic record controls are the same mechanics, and workflows are configured to whichever inspection reality you face — or both.
Can deviations link to batches?
Yes — events link to lots, batches, equipment, and personnel, so batch-record review and investigation queries pull the full context.
How long does implementation take for a pharma site?
8–12 weeks typical: documents and training first, then deviations and CAPA, then change control — with validation documentation delivered as each phase goes live.

See Kintavo configured for pharma & biotech.

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