Automate your CSV validation. Stay audit-ready.
ComplAI is the AI-powered platform that generates compliant validation documentation — URS, DQ, IQ, OQ, PQ protocols, risk analyses, traceability matrices — and manages the full signature and approval lifecycle, all in one place.
- Compliant with 21 CFR Part 11 & EU Annex 11
- Generates audit-ready documents in minutes, not weeks
- Electronic signatures with full immutable audit trail
- Built for GAMP5 and ICH Q9 frameworks
Why validation teams are overwhelmed
Computer System Validation (CSV) and Computer Software Assurance (CSA) are mandatory regulatory requirements for any pharma, biotech, or medical device company using computerized systems. And yet, most validation projects still run on Word documents, email chains, and manual approval routes.
Too much time on documents, not enough on science
Consultants spend over 70% of their time formatting, copying, and updating validation documents — instead of doing the actual expert validation work.
Audit failures from incomplete trails
Missing signatures, undocumented changes, and inconsistent versioning expose companies to regulatory findings during FDA, EMA, or notified body inspections.
No single source of truth
Validation documentation is scattered across shared drives, email attachments, and local folders. When an auditor asks for a document, it takes days to compile.
Approval bottlenecks slow everything down
Getting signatures from QA, IT, and business owners through email is slow, untraceable, and non-compliant. One missing signature can delay a system go-live for weeks.
Every project reinvents the wheel
Consultants create the same document structures from scratch for every project, with no reuse, no templates, and no consistency across the organization.
The validation platform that works as hard as you do
ComplAI replaces the manual, fragmented validation workflow with an integrated platform that generates GxP-compliant documentation using AI, manages the entire approval lifecycle with legally binding electronic signatures, and maintains an immutable audit trail — automatically.
Generate
AI generates your complete validation documentation set — from User Requirements Specifications to Qualification Protocols — using your corporate templates and your project data. In minutes.
Review & Approve
Route documents through a structured review and signature workflow that complies with 21 CFR Part 11. Every action is timestamped, attributable, and non-repudiable.
Audit Ready
Every change, every signature, every AI generation is captured in an immutable audit trail. When the inspector arrives, your documentation is complete, consistent, and traceable.
From project setup to approved documentation
— in days, not months
Create your validation project
Set up a project with system details, client information, team members, and applicable regulatory frameworks (GAMP5 category, validation stages). ComplAI pre-structures the documentation blocks you'll need.
Define User Requirements (URS)
Use the AI-assisted URS generator to capture and structure system requirements. The AI proposes requirements based on system type and regulatory context; your consultant reviews and confirms each one.
Generate qualification protocols
With confirmed requirements in place, ComplAI generates DQ, IQ, OQ, and PQ protocols — each referencing the relevant URS requirements with full traceability.
Execute and record results
Testers execute protocols step by step inside the platform, recording PASS / FAIL / NA results, attaching evidence, and logging deviations in real time.
Generate execution reports
Once execution is complete, ComplAI automatically generates execution reports, deviation summaries, and a final Validation Report with a qualification conclusion based on open deviation severity.
Route for signatures and approval
Documents are routed through configurable signature workflows (Generator → Reviewer → Approver). Internal and external signatories sign with a secure PIN, compliant with 21 CFR Part 11 §11.100.
Everything you need for compliant validation
— nothing you don't
Nine purpose-built modules covering the entire CSV/CSA lifecycle, from initial requirements to final regulatory archive.
AI Document Generation
Generate complete, audit-ready documents in minutes
ComplAI uses Claude AI (Anthropic) to generate all validation documents from your corporate Word templates, filling every field from project data and confirmed requirements.
- →Generates URS, DQ, IQ, OQ, PQ protocols, Risk Analysis, Validation Report
- →Uses your corporate templates — not generic ones
- →One AI call per document — no hallucinations from partial context
- →Supports bilingual generation (ES / EN / PT)
Electronic Signatures (21 CFR Part 11)
Legally binding. Fully compliant. Completely traceable.
A structured, sequential signing workflow that meets the requirements of 21 CFR Part 11 and EU Annex 11 §5.
- →Roles: Generator → Reviewer (optional) → Approver
- →PIN-based authentication as second factor
- →External signatories via secure token link — no account required
- →Automatic version escalation on final approval (e.g., 0.3 → 1.0)
Immutable Audit Trail (ALCOA+)
Every action. Every user. Every timestamp. Forever.
Write-only and tamper-evident audit log meeting ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available.
- →Captures edits, AI generations, signatures, rejections, version changes
- →No UPDATE or DELETE operations on audit records
- →Exportable for regulatory submissions
- →Admin UI with full filtering and search
URS Generator
From blank page to confirmed requirements in hours
AI-assisted User Requirements Specification builder with change tracking and full traceability to downstream qualification tests.
- →AI proposes requirements by module based on system type
- →Each requirement: Draft → Confirmed lifecycle
- →Change log with mandatory reason for every edit
- →Coverage tracker: % of URS requirements covered per protocol
Protocol Execution
Execute tests inside the platform. No paper. No Excel.
Testers execute qualification protocols step by step within ComplAI, recording results in real time. The platform validates test completeness before allowing report generation.
- →PASS / FAIL / NA per step with evidence capture
- →Inline deviation logging linked to specific test steps
- →Execution locked until all steps have results
- →Auto-calculation of conformity percentage
Deviation Management
Track, investigate, and close deviations — with full regulatory context
Every deviation detected during protocol execution is captured, classified by severity, and linked to corrective and preventive actions.
- →Severity: Critical / Major / Minor
- →Status: Open → Under Investigation → Under Review → Closed
- →Qualification conclusion driven by open deviation severity
- →Linked to specific test steps and qualification phases
Risk Analysis (FMEA / GAMP5)
ICH Q9 and GAMP5-aligned risk assessment, AI-assisted
FMEA-based risk assessments generated from your confirmed URS requirements, scoring each risk using the GAMP5 Risk Priority Number formula (S × P × D).
- →RPN scale 1–27: Low, Medium, High, Critical
- →AI generates risks from confirmed URS — consultant confirms or edits
- →OOXML table injected into corporate Word template
Traceability Matrix (RTM)
Full bidirectional traceability from requirements to test results
The Requirements Traceability Matrix is computed in real time from the database — always accurate, never stale.
- →Links: URS → Risk → DQ/IQ/OQ/PQ Test Step → Execution Result
- →Computed live — no manual maintenance
- →Export to Excel (matrix + statistics sheets)
- →Visual coverage indicator per requirement
SAP Integration & Role-Based Access
Pull live data. Control access precisely.
ComplAI integrates with SAP via OData REST and implements a 3-layer role-based access control model.
- →Supports LIMS, ERP, MES, SCADA, QMS, EDMS, SaaS systems
- →Global roles with module-level permissions (Read / Write / Admin)
- →Signature roles configured per document
- →Client portal with visibility limited to their documents
Built for regulated industries
— from the ground up
| Framework | Coverage |
|---|---|
| 21 CFR Part 11 | Electronic records, electronic signatures |
| EU Annex 11 | Computerised systems in GxP environments |
| GAMP5 (2nd Ed.) | Software categorization, risk-based approach |
| ICH Q9 (Rev. 1) | Quality risk management (FMEA methodology) |
| UNE 66175:2003 | Validation management indicators |
| ALCOA+ | Data integrity principles |
Trusted for validation across regulated industries
Pharmaceutical Manufacturing
Validate LIMS, ERP, MES, and SCADA systems used in drug manufacturing. Manage DQ/IQ/OQ/PQ documentation from initial URS to final Validation Report — compliant with FDA 21 CFR Part 11 and EU GMP Annex 11.
Biotechnology
Validate software systems supporting bioprocess development, clinical trials, and quality management. ComplAI handles the full GAMP5 lifecycle with AI-assisted protocol generation and electronic approval workflows.
Medical Devices
Manage IQ/OQ/PQ validation for manufacturing and quality systems under ISO 13485 and 21 CFR Part 820. Full traceability from design controls to executed tests.
Contract Research Organizations (CROs)
Validate clinical data management systems, CTMS, and eTMF platforms. ComplAI's multi-project architecture lets CROs manage validation for multiple sponsors simultaneously.
Regulatory Consulting Firms
Run validation projects for multiple clients from a single platform. Each project is isolated, client-branded, and can be exported at project closure.
Ask your validation data anything
ComplAI's Audit Copilot is an AI assistant trained on your project documentation, deviation records, signature history, and regulatory corpus. When an inspector walks in, you have instant answers.
The Copilot surfaces the relevant documents, cites the specific records, and generates a human-readable answer — with links to the source documentation.
Real-time visibility across all your validation projects
Give validation managers and QA directors an instant, comprehensive view of the entire validation portfolio.
Project Status
Live view of all active validations — stages, progress, and open action items across every project in your portfolio.
Document Pipeline
Documents in draft, review, pending signature, or approved — with bottleneck analysis by signer and document type.
Upcoming Deadlines
Milestones and corrective action due dates surfaced automatically, before they become a compliance risk.
UNE 66175:2003 KPIs
10 validation management indicators with traffic-light status and trend (↑↓) per the Spanish validation management standard.
Conformity Trend
Weekly snapshot of qualification conformity rates across all projects — spot regressions before they escalate.
Pending Signatures
Bottleneck analysis by signer and document — know who is blocking approvals and by how long.
Enterprise-grade infrastructure. Zero maintenance.
ComplAI is a fully managed SaaS platform with automatic deployments and persistent storage.
Encryption in transit
TLS 1.3 for all connections. No plaintext data ever transmitted.
XSS & injection protection
All user HTML content sanitized with DOMPurify. Every API endpoint validates role and module permissions.
Rate limiting
Database-backed rate limiting with no in-memory state. Account lockout after failed PIN attempts.
Audit immutability
Audit log is append-only at application and database level. No UPDATE or DELETE permitted — ever.
Frequently asked questions about GxP validation software
Built by validation consultants,
for validation consultants
ComplAI was built by Quialitech — a team with over 20 years of hands-on GxP validation experience across the EU, USA, and Latin America. Our team includes validation SMEs, QA directors, and regulatory affairs specialists who have run hundreds of CSV and CSA projects for pharma, biotech, and medical device companies.
We have validated LIMS, ERP, MES, CTMS, EDMS, and manufacturing control systems for companies inspected by the FDA, EMA, ANVISA, and EU national competent authorities. Our mission is simple: let consultants focus on expertise, judgment, and client relationships — and let the platform handle the documentation.
ComplAI is not a document editor. It is not a SharePoint replacement. It is a validation automation engine, purpose-built for regulated industries — designed by people who have lived through the inspections, the audit findings, and the pressure of regulatory submissions.
Validation, automated.
Let's talk about your
validation needs.
Whether you need a demo, have technical questions, or want to explore how ComplAI fits into your workflow — we'd love to hear from you.
- ✓30-minute discovery call at your convenience
- ✓Live walkthrough of a validation project from URS to approved documentation
- ✓Custom pricing based on your team size and use case
- ✓Dedicated implementation support from day one
Your next audit could be tomorrow.
Don't let documentation gaps become findings.
ComplAI keeps your validation documentation complete, traceable, and approval-ready — always. Book a 30-minute demo and we'll walk you through a live validation project from URS to approved documentation.
No commitment required · 30-day pilot available · Implementation support included