The current SOP, quoted with its number and effective date, when a supervisor asks.
In a regulated plant, following the wrong version of a procedure is a deviation waiting to happen, and QA teams spend their weeks on triage that follows familiar patterns. We build assistants that answer from the current, effective SOPs and draft deviation triage for QA to decide, on servers inside the plant.
Book a 15-minute callWhere the hours go
- Supervisors searching the document system for the current version of an SOP.
- QA officers categorising every new deviation from scratch.
- Similar past deviations, and the CAPAs that closed them, sitting in reports nobody has time to read.
What we've built for Pharma
SOP Navigator
PharmaAnswers "what's the procedure for…" from the current, effective SOP, quoted with its number and effective date, on a machine inside the plant.
Open SOP NavigatorOn our workbench for Pharma
If one of these would help you, tell us and it moves up the queue.
- Deviation Triage AssistantReads each new deviation, suggests a category and severity with its reasons, finds similar past deviations and their CAPAs, and drafts the investigation outline for QA to decide.In progressAsk for a preview: Deviation Triage Assistant
What else is possible
We haven't built these, but we would, for the right firm:
- A batch-record review assistant that marks missing entries before the record reaches QA.
Where we'd tell you not to use AI
Closing a deviation or releasing a batch. Those decisions stay with qualified people.
The rules you work under
GMP rules apply, and any system used for regulated records needs computer-system validation — 21 CFR Part 11 for the US, EU GMP Annex 11 for Europe. Our demos are not validated systems. A pilot runs alongside your validation partner.
Sources
How it runs for you
On a server inside the plant network, with no outbound connection.
Security and complianceStart with an audit (from $3,500) or go straight to a pilot (from $15,000)
