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# How a Top 3 Pharma Company Reduced Documentation Time by 70% with AI‑Enabled Compliance Workflows

One of the world's top 3 pharmaceutical companies develops software-driven diagnostic systems. Ketryx sits on top of the company's existing tools across programs, so validated AI agents apply lifecycle controls to every system and release rather than validating each one separately. Documentation time is reduced by 70%, and release cycles are 90% shorter.

## Impact

### Three months to one week

End-to-end release cycles

### 70%

Reduction in documentation time

### 50%+

Savings in tooling costs

Industry  
Pharma  
Device Type  
Diagnostics + SaMD  
Tech Stack  
Jira, GitHub

**Pain Point: Engineering was not the bottleneck. Compliance was.**  
Code was routinely wrapped and ready to push well before the release window opened. The delay lived in compliance, but the problem wasn't processes or standards. It was the tooling meant to manage it:

- **Tool sprawl created hidden compliance gaps:** Teams worked across separate systems with inconsistent adoption and processes. Work duplicated, records were misaligned, and compliance risk quietly accumulated in the gaps between platforms.
- **Documentation trailed every release:** Every development cycle ended in a documentation sprint, with QA and R&D cleaning up old releases instead of preparing for the next ones.
- **Compliance issues surfaced when they were most expensive to fix:** Gaps stayed invisible until teams were already deep in the release process, when resolving them was slow, costly, and disruptive to future release timelines

**Solution: Quality built into existing workflows. No migration required.**  
Jira, GitHub, and the rest of the engineering toolchain remained intact. Ketryx overlaid the environment around those tools, embedding compliance infrastructure and validated GxP AI without requiring a platform migration.

- **Compliance at the point of work:** Quality controls and traceability embedded into engineering workflows, with no new platform for engineers to learn or maintain
- **Real-time traceability across the full development stack:** Requirements, risks, tests, and designs linked end-to-end across connected tools and ALMs
- **Automated evidence generation:** Compliance documentation populated automatically as a byproduct of engineering activity

**Business Outcome: 90% Faster Release Cycle**

- **3 months to 1 week:** Embedding compliance into existing workflows stopped rework from accumulating at the end of every cycle and unlocked 90% faster releases
- **70% reduction in documentation time:** Continuous traceability standardizes a baseline of regulatory readiness, so documentation no longer piles up between releases
- **>50% savings in tooling costs:** Staying in existing tools let the team consolidate their compliance stack without replacing what already worked

## “I almost can't believe it, but as your website says, we did reduce our documentation time by over 90%.”

Senior Director, Quality

Building AI-Enabled Medical Software?

## Compliance is a control problem. Solve it inside the tools your teams already use.