Our Mission

We're building the documentation platform that pharmaceutical engineering deserves.

C&Q documentation has been stuck in the past for decades — written from scratch, prone to human error, and consuming engineering time that should be spent qualifying equipment, not filling in templates.

The Problem

Pharmaceutical documentation is broken.

A single commissioning and qualification project can require dozens of IQ, OQ, PQ, DQ, FAT, SAT, and RTM documents — each running to hundreds of pages, each referencing multiple regulatory standards, and each requiring review and approval from multiple specialists.

Engineering firms spend 60–70% of project time on documentation that should take a fraction of that. The cost is real: delayed manufacturing, missed compliance deadlines, and talented engineers trapped writing boilerplate instead of solving problems.

4–8 wks
Weeks per document
Writing from scratch every time
35%
Average rework rate
Inconsistent formatting & references
65%
Engineering time on docs
Time not spent on actual engineering
1 in 4
Compliance gaps found post-submission
Late-stage surprises delay approvals
Our Approach

Purpose-built for pharmaceutical compliance

Protokol is not a generic AI writing tool applied to pharma. Every feature is designed around the specific requirements of C&Q documentation and the regulatory frameworks your auditors expect.

01
Regulatory-grounded generation
Every AI-generated section is grounded in your uploaded specs and references the correct regulatory basis — 21 CFR, EU Annex 15, ICH Q7A — automatically.
02
Structured for review
Documents are divided into reviewable sections with inline commenting, version control, and a clear approval chain. Nothing gets lost.
03
Compliance by design
Part 11 e-signatures, immutable audit events, document hashing at approval, and role-based access are not bolt-ons — they are the foundation.
What We Stand For

Three principles we don't compromise on

01
Compliance first
We never sacrifice regulatory correctness for convenience. If the AI is uncertain about a regulatory reference, it says so. Auditability is non-negotiable.
02
Built for engineers
We understand that C&Q engineers are highly skilled professionals, not typists. Protokol handles the documentation so they can focus on what they were trained to do.
03
Trust through transparency
Every action is logged, every version retained, every AI suggestion traceable. The system works for you even when your auditor arrives unannounced.
Where We're Headed

A three-phase journey to full validation

Phase 1
Now
AI Document Authoring Platform

Protokol generates compliant C&Q documents grounded in your specs. Documents are exported to your existing validated DMS. Full 21 CFR Part 11 technical controls in the platform itself.

IQ, OQ, PQ, DQ, FAT, SAT, RTM generation
Knowledge Vault with RAG
E-signatures and approval workflows
Complete audit trail and export pipeline
Phase 2
Q3 2025
Collaboration & External Review

Enhanced multi-organisation collaboration, external reviewer portal, and deeper integration with leading DMS platforms.

External reviewer portal
DMS integrations (Veeva, OpenText)
Advanced RTM analytics
Multi-site project management
Phase 3
2026
Validated Electronic Records System

Following completion of the full GAMP5 Computer System Validation package, Protokol will be repositioned as a standalone 21 CFR Part 11 compliant electronic records system.

Full GAMP5 CSV package
21 CFR Part 11 standalone positioning
EU Annex 11 compliance
Regulatory submission-ready audit reports

Ready to see it in action?

Talk to us about your current C&Q documentation process and see exactly how Protokol would fit your workflow.

Request a Demo