Computer Software Assurance demo
Every function of a GxP system placed on a risk grid of patient-safety impact and likelihood of failure, so scripted testing goes only where the risk is, and every requirement traces to its proof. 1:15
What the demo shows
A GxP validation solution for validation teams that builds risk-based tests and trace matrices.
Six agents read the URS, configuration specification, intended use, supplier validation package, SOC 2 report and the company CSV/CSA SOP; group requirements into functions; and place each function on a grid of impact on patient safety and product quality against the likelihood of failure. The cell sets the assurance method and its hours: robust scripts where both are high, limited scripts, unscripted charters, accepted supplier evidence or a recorded rationale. Where the company SOP is stricter than the grid, the validation lead decides. Then the plan, scripts, charters and trace matrix are drafted with citations to the source paragraph, and the lead, system owner and IT Quality sign under 21 CFR Part 11.
Transcript
- Computer Software Assurance builds risk-based tests and trace matrices for GxP validation teams.
- Scripting every requirement of one new lab module takes about 118 hours.
- Omar presses place functions.
- Six agents read 42 requirements from six sources.
- Each function lands on the grid by its impact on patients and its likelihood of failure.
- Only six land in the high-risk corner and get robust scripts.
- Backup rests on the supplier's SOC2 evidence.
- User access sits in an unscripted cell, but the SOP is stricter.
- Omar picks a limited script.
- Every requirement traces to its proof, and Omar signs his author.
- 56 hours of testing, not 118, size to each function's risk.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.