GCP Inspection Readiness demo
A war room for GCP inspections: a readiness radar across nine areas, storyboards backed sentence by sentence by the TMF, and inspector questions rehearsed with cited answers. 1:13
What the demo shows
A GCP inspection solution for clinical QA that builds storyboards and rehearses questions.
Opens on the war room: a countdown to the opening meeting, the readiness radar across nine inspection areas and a storyboard wall where every frame shows whether the record supports it. Agents index the TMF and quality records in place, draft eight-frame storyboards with a citation on every sentence, flag statements the record cannot back, play the inspector in mock sessions and fetch documents for the back room. The QA lead signs each storyboard inspection-ready.
Transcript
- GCP Inspection Readiness gets clinical QA ready for FDA and MHRA inspections.
- At the MHRA, seven of 15 sponsors in one year had a critical finding.
- FDA arrives in 19 days.
- The radar scores nine inspection areas.
- Protocol compliance has dropped to 72.
- One click opens the site 114 visit window storyboard at the frame that fails.
- That training claim is not in the record.
- The log shows why.
- The likely inspector question is ready.
- Its answer is cited line by line.
- In a mock inspection, the record checks each sentence Dr.
- Chen says. Readiness rose 21 points in a month.
- Documents come back in 41 seconds.
- Build on Botminds, agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.