What we build
Two workflows, built for 21 CFR Part 111 operations. Each one takes the reading and assembly work off the quality unit and hands back a prepared record for review.
Incoming CoA review and ingredient release
- What the reviewer does today
- Opens the supplier CoA, reads it against the approved component specification, and checks identity, potency, heavy metals, microbiological limits, pesticide residues, residual solvents and allergens line by line. Values are transcribed into a spreadsheet or a paper form, then a second person often verifies the transcription.
- What the agent does
- Reads the document in whatever layout the supplier uses, extracts every parameter with its method, unit and reported value, maps each one to your specification including synonyms and unit conversions, and marks each row in specification or out of specification with the source value visible.
- What it needs
- Your current component specifications with revision numbers, the approved supplier list, your method equivalence rules, and access to wherever supplier documents arrive — email, a shared drive, or a supplier portal export.
- What it produces
- A prepared comparison for the ingredient lot, an exception list covering out-of-specification results, missing tests and unmatched parameters, and an attributable record of every extraction and mapping decision.
- What still needs human sign-off
- Identity testing conclusions, acceptance of any out-of-specification result, and the disposition of the ingredient lot. The quality unit signs; the agent does not.
Batch record review and release
- What the reviewer does today
- Reads the batch production record against the master manufacturing record page by page before release, checking that every step is signed, every verification is completed, in-process and finished-product results meet specification, and open deviations are resolved.
- What the agent does
- Works the record ahead of the reviewer: reconciles it against the master manufacturing record, collects missing signatures, blank entries and out-of-sequence operations, checks results against specification, and links open deviations and CAPA references to the steps they touch.
- What it needs
- The master manufacturing record for the product, the finished-product specification, the batch production record itself, and your deviation and CAPA log.
- What it produces
- An annotated review packet ordered by exception rather than by page, with links back to each source page, plus a summary of retain sample and yield reconciliation entries.
- What still needs human sign-off
- Investigation conclusions, deviation closure, overage and yield acceptance, and the batch disposition itself, which remains the responsibility of the quality unit.
Roadmap
Not built yet. These are the workflows we intend to take on next.
- Label and claim review across markets (roadmap)
- Deviation and CAPA handling (roadmap)
- Brand-owner audit and questionnaire response (roadmap)
- Master manufacturing record drafting for new SKUs (roadmap)