The AI-native IDE for pharmaceutical validation. Connect your JIRA. Write your structured URS. We automatically generate your IQ/OQ/PQ and live Traceability Matrix in seconds.
Stop manually updating Word docs and Excel matrices.
Treat your validation package like code.
When a URS requirement changes, the dependency graph instantly flags the exact Functional Specs, OQ test scripts, and SOPs that break. Review the AI-generated updates and recompile your validation package in minutes, not weeks.
Cryptographic audit trails, meaning-of-signature captures, and role-based access controls are built into the core. Every AI action is version-controlled and requires human sign-off.
The AI linter runs in the background while you type, instantly flagging untestable statements or missing acceptance criteria before they ever reach the risk assessment phase.
REQ-012: System shall log all user actions
The system must be highly secure
"The system must support AES-256 encryption for data at rest and TLS 1.3 for data in transit."
REQ-014: Response time ≤ 200ms at P95
Press compile and watch your bidirectional Requirement Traceability Matrix generate itself.
| Req ID | Func Spec | Risk | OQ Script | Status |
|---|---|---|---|---|
| REQ-001 | FS-001 | Low | OQ-001 | ✓ Traced |
| REQ-002 | FS-002 | Med | OQ-003 | ✓ Traced |
| REQ-003 | FS-003 | High | OQ-007 | ✓ Traced |
| REQ-004 | FS-004 | Low | OQ-009 | ✓ Traced |
Ingest requirements directly from JIRA, GitHub, and Confluence. No more copy-pasting.
Different stakeholders, same source of truth.
Stop copy-pasting between JIRA, Word, and Excel. Write once in the IDE — the compiler handles the rest. Ship protocols 10× faster.
Every requirement traced. Every test linked. Every change logged with a Part 11 timestamp. Your audit package generates itself.
Manage validation across multiple clients and systems without scaling your team. Standard templates, client-specific compilations.
Time savings on validation documentation
Average compilation time for full protocol suite
Traceability coverage — zero orphaned tests
Audit findings from traceability gaps
We believe validation is a deterministic function, not an art project.
Read the thinking behind the compiler.
Why treating your URS as source code — and your validation lifecycle as a build pipeline — eliminates the document entropy that causes audit failures.
Read manifesto →A step-by-step playbook for migrating from traditional CSV to the FDA's Computer Software Assurance framework — with ComplioLabs as your runtime.
Read guide →Our technical architecture for electronic records, electronic signatures, and audit trails. Every timestamp, every hash, every chain of custody — documented.
Read statement →Seat-based. No hidden fees. No "contact sales" gatekeeping.
For small validation teams getting started with structured authoring.
For mid-market validation teams. Full compiler with change control.
For CDMOs and large teams. Multi-tenant, custom profiles, dedicated support.
Join the private beta. Connect your JIRA in 60 seconds.
Start your pilot