Four capabilities. Same QA buyer.
Procedures, knowledge, data integrity, and cleaning execution - the four pillars of GMP operations - run as agents on the same private spine that runs Validate·AI.
Procedure authoring & maintenance.
Agents draft SOPs from source material - OEM equipment manuals, master procedures, regulatory references, and your existing library. Version control, periodic review triggers, and change-impact analysis run continuously.
- SOPs drafted against your house template, voice, and numbering
- OEM manual ingestion - PDF, scanned page, or DOCX
- Periodic review triggered by data change, not by calendar
- Change-impact analysis surfaces affected SOPs on system change
- Training-record propagation when an SOP revision lands
Operator knowledge layer.
Floor operators ask in natural language - "What's the bioreactor harvest procedure for Batch X?" - and get an answer with the SOP clause cited, the version stamped, and the query logged for training records.
- Natural-language queries on procedures, manuals, and standards
- Citations down to the clause and the SOP version
- Queries logged into the training record automatically
- Air-gap capable for shop-floor deployments without internet
- Multi-language support for global manufacturing sites
Continuous ALCOA+ audit.
Every batch record, every electronic record, every audit trail reviewed for ALCOA+ conformance on every cycle. Not sampled. Reviewed. Findings escalate to QA with a draft deviation; the rest archive cleanly.
- Every record, every cycle - 100 percent audit coverage
- ALCOA+ (9 criteria) checked at write time and review time
- MHRA, WHO TRS 1019, and PIC/S PI 041 aligned
- Findings drafted as deviations; QA owns the signature
- Audit dashboards for QA leadership and site management
Cleaning lifecycle execution.
Every cleaning event scheduled, executed, recorded, and released - under your SOP library, on your tenant, ALCOA+ on every cycle.
- Scheduled per validated frequency - event, time, or usage-based
- Right SOP revision served to the operator on the floor
- Structured electronic record - operator, detergent lot, contact time, rinse, visual
- QA review and release routed through your normal change-control regime
- Equipment status (Clean / In use / Dirty / Maintenance) live across the MES
Five questions a Head of Quality will ask first.
We do not replace them. We make them author themselves and audit themselves.
Vault QualityDocs and MasterControl are excellent systems of record for controlled documents. The expensive work is the authoring (drafting an SOP from an OEM manual takes weeks), the maintenance (periodic review, change-impact analysis), and the audit (sample-based ALCOA+ review).
Operate·AI runs that work as agents. Drafts land back in your QualityDocs / MasterControl tenant under your normal change-control regime. Your system of record stays where it is. The work above it changes.
Every record passes the nine ALCOA+ criteria on every cycle. Operationally that means:
Write time. The platform validates the record against the criteria as it is written. A record missing an attributable identity, a server timestamp, or a required-by-template field is rejected at the point of capture - before the operator finishes the task.
Review time. A separate agent reviews the persisted record against the criteria again - independent control. Drift between write-time state and review-time state surfaces as a deviation draft.
Sample sizes regulators expect (100 percent) at the throughput humans cannot sustain (1-2 percent). Findings escalate; the rest archive clean.
The MHRA GxP Data Integrity Guidance and Definitions (March 2018) is operationalised end-to-end. Data-integrity culture, data lifecycle (creation, processing, review, reporting, retention, retrieval, archive, destruction), and risk-based controls per record type.
Static vs. dynamic data is differentiated. Original records vs. true copies are tracked explicitly. Audit trail review is continuous and risk-prioritised - exactly as the guidance requires. The control framework aligns to PIC/S PI 041-1 and WHO TRS 1019 Annex 5.
Native, bi-directional connectors for the three MES/EBR systems most life-sciences customers run:
Werum PAS-X. Master batch records, recipe authoring, and shop-floor execution data flow into the ALCOA+ audit pipeline. Procedure authoring delivers to PAS-X under your normal change-control regime.
Rockwell PharmaSuite. Same pattern - EBRs in, procedures out, deviations and CAPAs routed to your eQMS.
Tulip Frontline Operations. Operator-facing app integration. The knowledge layer is exposed to operators inside the Tulip-built application; queries are logged for training; SOP citations appear inline.
Yes. For sites with strict network isolation (filling lines, sterile suites, classified manufacturing) the knowledge layer can run fully air-gapped against an on-site local model.
The procedure index is built and signed centrally, then shipped as an offline artefact. Operator queries run against the local index using a local LLM. Query logs replicate back to the central audit trail on the next sync window. Updates land via signed releases, never via outbound network calls.
Sits on the systems you already run.
Native connectors with eQMS, MES, EBR, historian, and operator-experience platforms - so Operate·AI lives where the work lives.