AI for Deviation & CAPA Drafting
Investigations that close faster, every time.
AI-assisted root cause analysis for life sciences manufacturing. Purpose-built for GMP environments where precision and investigation timelines matter.
Investigation Summary
Generated · Ready to export
Built for regulated manufacturing environments
Why life sciences manufacturers choose Qualigon
Start every deviation with the right level of rigor
Each case enters an ICH Q9-aligned checklist. Qualigon guides the risk-based assessment, surfaces the applicable regulations, and indicates whether the deviation can remain minor or may require escalation — with a consistent, structured approach across sites and shifts.
Minor events: guided, drafted, closed in ~1 hour
For the low-risk cases that dominate most backlogs, Qualigon runs the full workflow. It guides investigators what data to pull, fetches it, structures the analysis, and generates a compliant write-up ready to load into your QMS. What used to take 2–3 days now takes about an hour — freeing the team to focus on what actually needs their expertise.
Significant deviations: go deep when it matters
Full investigations require digging through massive volumes of data across systems. Qualigon does that work for you. It pulls and analyzes batch records, historian data, equipment logs, and prior CAPA history — highlights anomalies, and ranks the most plausible root causes with citations to the sources it used. Investigators can focus on judgment, not data gathering.
Candidate Cause
Equipment miscalibration
Batch #2024-099 · 87% match
Source: DEV-2022-441
✓ Accepted · J. Smith · QA
Logged 10:42 · Audit trail updated
Human-in-the-loop by design
The investigator stays in control. AI proposes; qualified staff evaluates and decides. Every candidate cause is traceable to a source, every conclusion reviewable, every approval logged.
Quality Checklist
Consistent quality, regardless of who investigates
Junior investigators produce the same defensible analyses as your most senior staff. Output quality is no longer person-dependent — it is process-dependent.
Prior Cases
3 related cases found
DEV-2022-441
Heat sealer #3 · Resolved
DEV-2023-089
Same root cause confirmed
DEV-2024-012
Escalated → CAPA #88
Institutional knowledge that compounds
Site-specific patterns, historical failure modes, and prior CAPA outcomes are embedded in the system — not locked in the heads of your most experienced investigators.
Audit Trail
Investigation opened
J. Smith
Root cause accepted
J. Smith
CAPA initiated
M. Patel
Report signed off
R. Nguyen
Audit-ready records, always
Built with regulatory requirements in mind, including 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity principles.
How it works
From deviation to
closed record.
A risk-based workflow that routes each deviation to the right level of investigation — automatically.
01
Deviation logged in your QMS
Veeva, TrackWise, or any connected system — no duplicate records
02
Guided interviews
SOPs and batch records pulled · interview questionnaire drafted · recording reconciled automatically with the analysis
03
Risk assessed — deviation classified
ICH Q9-aligned checklist · applicable regulations surfaced
Fast resolution
80–90% of cases
Guided workflow · data fetched · compliant write-up generated
~1 hour to close
Deep investigation
10–20% of cases
Batch records · historian data · ranked RCA hypotheses
Structured, cited, traceable
05
Investigator reviews and confirms
AI drafts the report · qualified staff approves or adjusts · every conclusion traceable to a source
06
CAPA initiated — when warranted
Not every deviation requires one · routed through your existing approval workflow
07
Investigation approved and closed
Fully traceable audit trail · batch release proceeds
Integrations
Works with the systems you already have.
Qualigon connects to your existing QMS, documents, and supporting systems to assemble the information needed for a deviation investigation. No parallel records.
Quality & Compliance
Veeva Vault QMS
TrackWise
MasterControl
SAP QM
ETQ Reliance
Process & Manufacturing
DeltaV
OSIsoft PI
Werum PAS-X
Rockwell PharmaSuite
SAP MES
Lab & Testing
LabWare LIMS
STARLIMS
GLIMS
LabVantage
JMP
SIMCA
Documentation
SharePoint
Documentum
Veeva Vault DMS
OpenText
Don't see your system? We connect to your stack.
Talk to us about your environmentSecurity
Enterprise-grade security,
by default.
Qualigon is built for regulated environments where data integrity and confidentiality are non-negotiable. Security is not a feature tier — it is the foundation.
No training on your data
Your investigation records, batch data, and documents are never used to train AI models — yours or anyone else's.
Encrypted in transit and at rest
All data is encrypted with AES-256 at rest and TLS 1.3 in transit. Keys are managed per customer and rotated on schedule.
GDPR compliant
Data residency controls, DPA templates, and right-to-erasure workflows are built in — not bolted on.
End-to-end traceability
Every AI-generated output is tied to the source record that produced it. Nothing enters the audit trail without a human decision attached.
Tenant separation
Each customer environment is logically isolated at the infrastructure level. No shared compute, no shared storage, no cross-tenant data access.
Role-based access control
Granular permissions map to your existing org structure. Investigators, reviewers, and approvers see only what their role permits.
Compliance
Regulatory requirements
embedded by design.
Qualigon was built from the ground up with regulatory requirements as the starting point, not layered on after. Consistency, traceability, and audit readiness at every step.
FDA
21 CFR Part 11
FDA
21 CFR Part 210/211
FDA
21 CFR Part 600–680
FDA
21 CFR Part 820
FDA
OOS Guidance
EU / GMP
EU GMP
EU / GMP
GMP Annex 11
ICH
ICH Q7
ICH
ICH Q8 (R2)
ICH
ICH Q9 (R1)
ICH
ICH Q10
Industry
GAMP 5
Industry
ISO 9001
Industry
ISO 13485
Industry
USP Chapters
Get started
Reduce investigation time
without compromising compliance.
See Qualigon running on your deviation workflow — book a demo with the team.
Request a demo