AI-Powered C&Q Document Intelligence

Stop writing C&Q
documents from
scratch.

Protokol AI generates compliant IQ, OQ, PQ, DQ, FAT, SAT, and RTM documentation — grounded in your specs and ready for regulatory submission.

See how it works

✓21 CFR Part 11

✓EU Annex 15

✓GAMP5 Ready

✓Audit-Ready

protokol — IQ Protocol Generator

AI Generating

Projects

GEA FD-30

  IQ Protocol

  OQ Protocol

  PQ Protocol

WFI Loop System

  DQ Report

  FAT Protocol

AI References

21 CFR §211.68
Equipment qualification basis

EU Annex 15
Qualification & validation

ICH Q7A §12
GMP compliance statement

 Part 11 compliant

● DraftRev 01IQ ProtocolLn 1, Col 1

0%

reduction in documentation time

0+

document types generated by AI

0%

audit trail — every version, every sig

0 gaps

compliance gaps from day one

Everything you need

Built for pharmaceutical compliance

Every feature is designed around the unique requirements of C&Q documentation and regulatory submission.

AI Document Authoring

Generate section-by-section content for IQ, OQ, PQ, DQ, FAT, SAT, and RTM docs in minutes — grounded in your specs via RAG.

21 CFR Part 11 E-Signatures

Role-based electronic signatures with acknowledgement statements, identity verification, and immutable audit events.

RTM Auto-linking

AI automatically links requirements to test cases and approval records. Run on-demand or on a nightly schedule.

Knowledge Vault

Upload SOPs, URS docs, and equipment manuals. Protokol AI cites them automatically in every generated section.

DOCX & PDF Export

Export any approved document as a formatted Word file or PDF, ready to submit to your customer's validated DMS.

Immutable Audit Trail

Every edit, approval, and signature captured append-only. Document content is hashed at approval time. Inspection-ready always.

Simple workflow

From specs to signed documents in three steps

01

Upload your project specs

Import equipment specifications, URS documents, existing SOPs, and templates into your project vault. Protokol indexes everything for AI retrieval.

02

AI generates your documentation

Select a document type — IQ, OQ, PQ, DQ, FAT, SAT, or RTM. Protokol writes a fully structured, regulation-referenced first draft in minutes.

03

Review, approve, and export

Your team reviews section by section, leaves comments, and signs electronically. Export the final document as DOCX or PDF for your DMS.

Compliance-first

Built around the regulations that matter

Every generated document is structured to satisfy the regulatory frameworks your auditors and customers expect.

21 CFR Part 11

FDA Electronic Records & Signatures

EU GMP Annex 15

Qualification & Validation

GAMP5

Computer System Validation

ICH Q7A §12

API GMP Validation Requirements

Phase 1 positioning

Protokol is currently positioned as an intelligent document authoring platform. Generated documents are exported to your validated DMS. Full 21 CFR Part 11 system validation (GAMP5 CSV package) is in progress for Phase 3.

Pricing

Transparent pricing. Built for teams of all sizes.

All plans include AI generation, e-signatures, RTM traceability, and a complete audit trail.

Starter

From $499/mo

For small teams running focused qualification projects.

5 projects

50 documents

5 seats

Knowledge Vault

AI generation

E-signatures & audit trail

Get started

Ready to qualify
faster?

Join pharmaceutical engineering teams that are already cutting documentation time by 80%. See a live demo with your own documents.

See pricing