Agents that keep the plant audit-ready
A single deviation can hold a batch for days and a warning letter can hold a line for months. We deploy governed agents that close out records, route CAPAs, qualify suppliers, and keep your QMS inspection-ready — without touching a validated system unattended.
- 21 CFR Part 11 e-signatures & audit trails
- GMP, ISO 9001/13485, IATF 16949
- MES, LIMS & QMS integration
- Validated like any GxP system
Compliance is the bottleneck, not the line speed
In a regulated plant, the equipment rarely sets the pace. The paperwork does.
Quality teams spend their days on review-by-exception that isn't exceptional: reconciling electronic batch records against the master, chasing missing entries, transcribing results between LIMS and the QMS, and reformatting the same data for the next audit. Every one of those steps is a place a deviation can hide and a place an investigator will look.
Meanwhile deviations, CAPAs, and change controls pile up past their due dates, supplier requalifications slip, and training records drift out of date. None of it is hard work — it's high-volume, rules-bound, traceable work. Which is exactly the work an agent does well, provided it operates inside the same controls your people do.
Compliance workflows, automated
Each agent owns a bounded, well-defined quality process — and escalates anything ambiguous to a named reviewer.
Batch record review
Reconcile electronic batch records against the master, flag missing or out-of-spec entries, and assemble a review-by-exception packet for QA sign-off.
Deviation triage & CAPA
Classify deviations, draft the initial investigation, propose root cause from history, and route CAPAs with due-date tracking in your QMS.
Supplier qualification
Monitor supplier COAs, audit status, and requalification dates; assemble approved-supplier-list evidence and flag expirations before they bite.
Change control
Draft change requests, gather impact assessments across affected systems, and keep the cross-functional approval chain moving.
Audit & inspection prep
Answer investigator questions from your own controlled documents in seconds, with citations to the exact SOP, batch, or record.
Training & SOP currency
Cross-check training records against current SOP revisions, surface gaps by role, and queue re-training before an auditor finds the lapse.
Validated, not improvised
We treat every agent as a computer system subject to CSV/CSA — qualified before it touches your quality data.
Scope & risk
Define intended use, GxP impact, and a risk assessment for the target workflow with your QA and validation leads.
Architect controls
Design the action layer, approval gates, e-signature points, and audit-trail capture before any code ships.
Qualify
Execute IQ/OQ/PQ with a traceability matrix tied to FDA CSA guidance, signed off by QA.
Operate
Run in your environment with periodic review, change control, and full decision lineage for inspectors.
Inside your perimeter, inside your controls
Quality data is some of the most sensitive you have, and the OT network it lives next to is one you cannot afford to disturb. We deploy on-prem or in your VPC, network-segmented from the shop floor, reading from MES, LIMS, and historians through read-scoped connectors only.
Nothing leaves your environment. And nothing reaches a validated record on its own — every write to an eBR, a released spec, or a QMS record passes through an approval gate with a named, e-signed human. The agent does the legwork; your people own the decision.
- On-prem or VPC, segmented from OT
- Read-scoped MES/LIMS/historian access
- Approval gate + e-signature on every controlled write
Manual review vs. a governed agent
Same controls, same accountability — a fraction of the elapsed time.
| Manual quality review | An Automatic.co agent | |
|---|---|---|
| Batch record review | Line-by-line, hours per batch | Reconciled in minutes, exceptions surfaced |
| Deviation handling | Backlog past due dates | Triaged, drafted, and routed same day |
| Audit trail | Reconstructed after the fact | Captured live with full lineage |
| Inspector questions | Hours digging through binders | Cited answers from controlled docs |
| Authority | Human approves | Human approves — gate enforced in code |
Frequently asked questions
Will agents change validated records or master batch documents?
No. Agents draft, reconcile, and flag — they never alter a released eBR, validated master, or controlled spec without a named human approving the change. Every action lands in your QMS with full e-signature and audit-trail support under 21 CFR Part 11.
How do you handle computer system validation (CSV/CSA)?
We deliver agents as validated systems. Each workflow ships with intended-use documentation, risk assessment, IQ/OQ/PQ artifacts, and a traceability matrix aligned to the FDA's Computer Software Assurance guidance, so QA can qualify the agent like any other GxP system.
Can this run inside our plant network and OT environment?
Yes. We deploy on-prem or in your VPC, segmented from the OT/shop-floor network, reading from MES, LIMS, and historians through read-scoped connectors. Nothing leaves your perimeter and nothing writes to a validated system without an approval gate.
Which standards and systems do you support?
FDA 21 CFR Parts 210/211/820, ISO 9001 and 13485, EU GMP Annex 11, IATF 16949, and AS9100 — integrated with MasterControl, Veeva, TrackWise, Siemens Opcenter, SAP QM, and common MES/LIMS platforms.
Related industries & capabilities
Bring your toughest quality workflow.
One working session to map a GxP workflow, its controls, and the validated path to a production agent.