GxP SOP Authoring demo
SOPs drafted and updated from the regulations, change records and how the work is really done, every step tied to its source. 1:13
What the demo shows
A GxP document solution for quality teams that drafts and updates SOPs from their sources.
Agents find every SOP step a regulation or site change touches, draft the revised steps in the company template with each step tied to its source, and list who must be retrained; quality approves and signs under document control.
Transcript
- GxP SOP Authoring drafts and updates SOPs from their sources for quality teams.
- Procedure findings rank among the most cited at U.S.
- sterile sites. Revised Annex 11 wants audit trails reviewed before batch release.
- Ruth selects that clause.
- 17 SOPs light up, 23 steps, each change drafted.
- She opens SOP. QA 044.
- Step 6.3 said review annually.
- Now, before batch release, it's clause beside it.
- Every step names its source.
- One has none, her call.
- She deletes it. She sends all 17 for approval, with training for 146 people.
- Each revision takes two days, not 12.
- Built on Botminds.
- Agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.