Validation Document Automation demo
IQ, OQ and PQ protocols drafted from the requirements, with a live trace from every requirement to its tests. 1:15
What the demo shows
A GxP validation solution for validation engineers that drafts IQ, OQ and PQ protocols.
A traceability matrix sits at the center: every user requirement runs across to its functional-spec clause, its design record and the OQ test cases that prove it, with gaps and disagreements shown. Agents draft each protocol section from the current, approved sources and cite the page for every value. When a new revision of a requirement arrives, the change impact checker marks the test cases it touches and the section writer drafts the updated section for the author to accept.
Transcript
- Validation Document Automation drafts qualification protocols for validation engineers, every test traced to its requirement.
- By hand, a protocol takes days and one change requirement means checking every test.
- LENA's Bioreactor Protocol, 14 requirements through the design spec to 31 test steps.
- Gaps show at once, an alarm with no set point and agitation limits that disagree.
- This morning, revision four changed one line.
- Temperature now 28 to 40 degrees.
- Three test cases turn amber.
- The first one is untouched.
- The section writer drafts the updated section, citing the new page.
- Lena accepts, and Omar reviews version two.
- Drafted in minutes, Every value traced to its source.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.