BALKIRA

Two to three weeks to figure out what to automate, and especially what not to. Mapping of your IT/OT flows, analysis of APIs and access rights, identification of high-ROI, low-regulatory-risk use cases, on-premise vs. hybrid trade-offs. You walk away with a data map, a use case / effort / risk matrix, a costed target architecture, and a pre-filled DPIA template. Actionable deliverable even if you don't work with us afterward.

Your operators and line managers query your systems in plain language, no technical queries or training needed. "Why is line 4 stopped?" queries your MES, Historian, and deviation database in read-only mode, returning an answer with visible sources: alarms, batches, open deviations. Strict read-only access, full audit log viewable on screen, 100% on-premise deployment. Delivered with architecture diagram, API documentation, and knowledge transfer to your teams.

Regulatory documentation drafting, assisted without ever being delegated. Generation of draft URS, FS, DS, and IQ/OQ/PQ protocols from your reference guidelines and in-house templates. Enforced workflow: AI draft -> expert review -> sign-off. Native ALCOA+ audit trail on every version, automatically generated traceability matrix. No document leaves the workflow without tracked human validation.

Maintenance technicians dictate their report while working hands-on inside the machine, generating a structured report in real time. It's not about convenience: it's about the ALCOA+ contemporaneity principle: data entered two hours after the task is non-compliant. On-premise transcription (no external audio streams), custom industry jargon and equipment references tailored to your site, shop-floor noise resistance tested prior to deployment. Optional CMMS connectors (SAP PM, Maximo, CARL, Mobility Work).

A full day on-site for 4 to 12 people, built around your real use cases, not generic slides. Five core blocks: what an LLM can and cannot do, treating hallucinations as non-conformities rather than bugs, prompt writing and structured outputs, integration with your existing systems, and the regulatory framework (GDPR, AI Act, Annex 11, 21 CFR Part 11). Your teams leave fully capable of running and maintaining what we deploy. Travel expenses billed separately.