Early access open · GxP teams
GxP validation,
fully automated.
Agents that draft qualification documentation, maintain bidirectional traceability, and adapt your compliance workflows as regulations change.
Currently onboarding CDMOs and pharma validation teams · compliolabs.xyz
From URS to audit-ready output — in a single workflow
URS-001System shall control temperature at 2–8°C with ±0.5°C accuracy and log at ≥1 min intervalsCritical
URS-002Audit trail per 21 CFR Part 11 for all record creation, modification and deletion eventsCritical
URS-003User roles: System Admin, Operator, QA Reviewer — with role-specific permissions enforcedMajor
URS-004System shall generate LIMS export in CSV and PDF format on demandMinor
EXCEPTION
Audit trail gap — URS-002 not satisfied
User record deletion on Oct 14, 2025 has no corresponding audit log entry. Event occurred between backup cycles. Traceability to URS-002 broken.
LIMS DBRecord deleted 14-Oct 09:41No log
Audit LogGap: 09:38–09:55Missing
URS-00221 CFR Part 11 §11.10(e)Linked
AUDIT-READY
Requirements Traceability Matrix
RequirementTest refStatus
URS-001IQ-TC-003Pass
URS-002OQ-TC-005Review
URS-003OQ-TC-011Pass
URS-004PQ-TC-002Linked
Built for
CDMOs
Pharma Manufacturers
Biotech
MedTech
Validation Teams
How it works
Three steps from URS
to audit-ready
ComplioLabs is a compiler. You bring the requirements. We produce the qualified documentation package with every link maintained.
STEP 01
Input your requirements
Paste, upload, or draft your URS directly in ComplioLabs. The parser classifies each requirement by type, criticality, and applicable regulatory clause.
URSFRSChange ControlSOP Import
STEP 02
Generate your qualification package
The GxP compiler produces IQ, OQ, and PQ protocols, test scripts, acceptance criteria, and a bidirectional RTM — calibrated to your exact regulatory framework.
21 CFR Part 11EU Annex 11GAMP 5/6
STEP 03
Adapt as regulations change
When a regulation updates or a change request arrives, ComplioLabs propagates the impact across your document set — regenerating affected sections, flagging what needs human review.
Change ImpactDeviation MgmtLive Traceability
A smarter way to validate
ComplioLabs vs
every other approach
Manual validation is expensive and slow. Generic AI copilots don't understand GxP. Consultants are thorough but unaffordable at scale.
★ RECOMMENDEDComplioLabs
Manual / Excel
Generic AI Copilots
Validation Consultants
Documentation drafting
IQ/OQ/PQ from URS in hours
Days per document, from templates
Generic drafts, GxP context missing
Weeks, priced at $200–350/hr
Bidirectional traceability
Live RTM, auto-maintained
Manual spreadsheet, breaks on changes
Not supported — no system access
Maintained manually, billed hourly
Regulatory framework coverage
21 CFR · EU Annex 11/22 · GAMP 5/6 · ICH Q10
Whatever the engineer knows
No regulatory training data
Consultant-dependent, high variance
Regulation change propagation
Automatic impact analysis + re-draft
Full manual rework of all documents
Not possible — no document state
New engagement, new cost
Audit-ready output
FDA 483 / EMA-structured export
Depends on the engineer's format
Chat output — rarely holds up
Holds up, priced accordingly
Time per qualification cycle
Hours
8–14 weeks
Faster drafting, same slow setup
Weeks to months
Regulatory coverage
The frameworks your
team already operates in
21 CFR Part 11
FDA Electronic Records & Signatures
EU Annex 11
Computerised Systems (EU GMP)
EU Annex 22
Advanced Therapy Medicinal Products
GAMP 5 / GAMP 6
Good Automated Manufacturing Practice
ICH Q10
Pharmaceutical Quality Systems
21 CFR Part 820
FDA Quality System Regulation (Devices)
USP <1058>
Analytical Instrument Qualification
ICH E6 R3
Good Clinical Practice
"Regulations are not walls. They are the specification. ComplioLabs is the compiler that reads them."
Request early accessThe GxP landscape is not one framework. It's a matrix of overlapping guidance — FDA, EMA, PMDA — each with jurisdiction-specific requirements your validation package must satisfy simultaneously.
ComplioLabs maps each requirement to the applicable regulatory references, cites the specific clauses your documentation satisfies, and flags gaps where coverage is incomplete — before your auditor finds them.
As the regulatory corpus evolves — GAMP 6, FDA's 2022 CSA guidance, EU Annex 22 for ATMPs — your documentation adapts automatically, not on your next consultant engagement.
Who it's for
Built for teams that run
qualification at scale
If your business depends on moving qualified systems to market faster than your competitors, ComplioLabs is your distribution advantage.
Primary Beachhead
Contract Development & Manufacturing Orgs
CDMOs run 20–50 qualification cycles per year across multiple clients and jurisdictions. Every cycle saved is revenue moved forward.
- Multi-client regulatory frameworks in one workspace
- Template reuse compounds ROI across every cycle
- Faster client deliverables as a competitive differentiator
- Reduce dependence on contractor validation engineers
Expansion Market
Pharma & Biotech Manufacturers
Regulated manufacturers undergoing digital transformation, ERP migrations, or facility expansions face recurring, high-stakes qualification demands.
- ERP/MES/LIMS system validation
- CSV/CSA for new manufacturing lines
- Revalidation on process changes or site transfers
- Global FDA + EMA submissions simultaneously
Adjacent
MedTech & CROs
Medical device manufacturers and contract research organizations running qualification cycles under tight regulatory timelines.
- 21 CFR Part 820 Quality System documentation
- Clinical data system validation (CDMS, RTSM, eTMF)
- IND/BLA/NDA submission support
- Analytical instrument qualification (USP <1058>)
Compliance-grade infrastructure
Built for
regulated environments
Your validation data is evidence. It needs to be treated that way — not processed by a general-purpose AI with no audit trail.
Read-only by default
ComplioLabs reads your requirement inputs and writes only to your documentation workspace — never to systems of record without explicit approval.
Data accessInput-scoped only
WritesYour workspace only
LoggingAll actions recorded
Reviewer in the loop
No documentation finalises without a human reviewer. Every revision is versioned. Every approval is timestamped and attributed — meeting 21 CFR Part 11 audit trail requirements.
ApprovalsRole-gated
RevisionsFull version history
Audit trail21 CFR Part 11 aligned
Enterprise infrastructure
Tenant-isolated storage on AWS. Your validation data is never used to train models. Single-tenant deployment available for teams with strict data residency requirements.
HostingAWS, tenant isolated
EncryptionAES-256 + TLS 1.3
Model trainingYour data: never
Frequently asked
Questions your
QA director will ask
ComplioLabs generates documentation structured to the applicable regulatory framework — FDA, EMA, or both simultaneously. Every document includes the regulatory clause references that justify its structure. Every claim in the output is traceable to a requirement in your URS. That traceability chain is what an investigator examines — and it's what ComplioLabs makes unbroken by design. We do not recommend finalising any output without review by your QA team.
No. ComplioLabs handles the documentation drafting, traceability maintenance, and change propagation that currently consumes 60–80% of a validation engineer's time. Your engineer's judgment is still required for risk assessment, protocol review, and the decisions that require domain expertise. We give them back the time to do that work rather than spending it on document production.
During onboarding, we ingest your existing SOPs, templates, and document formats. ComplioLabs generates documentation that conforms to your house style — not a generic template. Your deviation log looks like your deviation log. Your IQ protocol follows your company's standard structure. We fit your QMS, not the other way around.
21 CFR Parts 11 and 820, EU Annex 11 and Annex 22, GAMP 5 and GAMP 6, ICH Q10, USP <1058>, and ICH E6 R3 for GCP. For teams submitting to multiple markets — FDA and EMA simultaneously — ComplioLabs maps your requirements to both frameworks in a single package. Additional frameworks are added on a rolling basis as the regulatory corpus expands.
ComplioLabs monitors the regulatory corpus for updates. When a relevant change is detected — a new guidance document, a revised framework, a jurisdiction-specific update — it runs an impact analysis against your active validation packages, flags the sections affected, and offers to re-draft them under the updated guidance. You review and approve. You are never caught off guard by a regulation change the night before an audit.
General-purpose LLMs have no understanding of your URS, no traceability to your requirements, no knowledge of your QMS, and no ability to maintain links between documents as things change. They produce plausible-sounding text — not structured, requirement-linked, audit-defensible documentation. ComplioLabs is a GxP-native system: your requirements are the input, your regulatory framework is the constraint, and your audit trail is the output. Every conclusion is traceable to source.
We're currently onboarding early access customers through a structured onboarding call. During that call we ingest your existing templates and SOPs, configure your regulatory framework settings, and run a pilot qualification package on a real URS from your team. Most early access customers are producing their first draft output within the same week.
Your next cycle starts
faster.
We're onboarding a small number of CDMOs and pharma validation teams. Help us build the validation platform your team actually needs.
✓
Full IQ/OQ/PQ generation from your URS✓
Live bidirectional traceability matrix✓
Calibrated to your regulatory framework✓
Audit-ready export — FDA / EMA structure✓
Onboarding with your existing templates and SOPsRequest early access
No commitment required. We'll be in touch within 48 hours.