Automation for Regulated Manufacturing
AI and workflow automation designed to survive an audit, for medical device, aerospace and automotive manufacturers.
AI and workflow automation designed to survive an audit, for medical device, aerospace and automotive manufacturers.
Medical device, aerospace and automotive quality systems use different rulebooks, but auditors ask the same questions: is it controlled, is it traceable, and can you prove it works.
ISO 13485, FDA QMSR and 21 CFR Part 11, with software validation scaled to risk (GAMP 5, Computer Software Assurance). Where automation helps most: CAPA, complaints, document and change control.
AS9100D, AS9102 first article inspection, AS9145 APQP and PPAP, NADCAP special processes, plus ITAR, EAR and CMMC for controlled data. Where automation helps most: FAI packages, configuration and change control, supplier certifications.
IATF 16949 and the AIAG core tools: APQP, PPAP, FMEA, SPC and MSA, plus 8D and customer-specific requirements. Where automation helps most: PPAP packages, PFMEA and control plan alignment, 8D intake, SPC alerts.
In a regulated plant, a clever workflow that cannot be controlled, traced and proven is a finding, not an improvement.
Automation built without a documented intended use and risk assessment cannot be validated or verified after the fact without rework.
Scripts and integrations that change quality records without a secure, time-stamped audit trail are a finding waiting to surface, whether the auditor is FDA, a registrar or your customer.
A prompt, model or workflow changed outside change control becomes an unvalidated system the day it changes.
High-volume, rules-heavy work where a qualified person still makes the decision, and automation removes the clerical load around it.
Complaints, nonconformances, deviations and customer returns routed, deduplicated and pre-classified. The CAPA or 8D owner makes every decision.
Review and approval workflows, periodic review reminders, and training triggers when a controlled document changes.
A first draft of affected documents, parts, validations and customer notifications, such as a PPAP resubmission or a partial FAI, for the change owner to confirm.
Certificates of conformance, material certs and analysis reports read, checked against specification and filed, with exceptions sent to a review queue.
PPAP elements and AS9102 forms assembled from data you already hold, with gaps flagged. The warrant and the FAI sign-off stay with your people.
An alert when the PFMEA, control plan and work instructions drift apart after a change, before an auditor finds it.
SPC and gauge data watched continuously, with out-of-control signals raised in context. People decide the reaction.
Evidence pulled together from the systems that already hold it, instead of by hand the week before the audit.
Compliance is designed in, not tested in at the end.
We define what the automation does and does not do, which quality records it touches, and the risk it carries. That scopes everything after it.
Role-based access, audit trails, human review wherever a wrong answer is expensive, and records that stay attributable to a person.
Requirements, risk-based testing and traceability, scaled to risk: GAMP 5 and FDA's Computer Software Assurance approach in life sciences, and equivalent software control in aerospace and automotive quality systems. Prepared for your quality team to review and approve.
Every change to a workflow, prompt or model goes through your change control, with monitoring that shows when outputs start to drift.
| Industry | Standard | What it means for automation |
|---|---|---|
| Medical device | ISO 13485:2016 | Software used in the quality management system must be validated before use, with effort proportionate to risk (clause 4.1.6). |
| Medical device (US) | FDA QMSR (21 CFR 820) | Since 2 February 2026, the FDA's quality system regulation for medical devices incorporates ISO 13485 by reference. |
| Life sciences | 21 CFR Part 11 | Electronic records and signatures: secure, time-stamped audit trails, limited system access, operational checks and signature controls. |
| Life sciences | GAMP 5 | A widely used risk-based approach to computerized system validation. |
| Aerospace and defense | AS9100D (EN 9100:2018) | The quality system standard for aviation, space and defense, adding configuration management, product safety and counterfeit parts prevention to ISO 9001. Its successor, IA9100, is expected in late 2026 or early 2027. |
| Aerospace and defense | AS9102 | First article inspection: documented proof that the first production part matches the design. |
| Aerospace and defense | AS9145 | APQP and PPAP requirements for aviation, space and defense. |
| Aerospace and defense | NADCAP | Accreditation for special processes such as heat treating, chemical processing and nondestructive testing. |
| Defense | ITAR and EAR | Export-controlled technical data: who may access it, and where it may be stored or processed. |
| Defense | CMMC | Cybersecurity requirements for Defense Department suppliers handling controlled unclassified information (CUI), phased into contracts since 10 November 2025. |
| Automotive | IATF 16949:2016 | The automotive quality system standard, built on ISO 9001, plus each customer's specific requirements. |
| Automotive | AIAG core tools | APQP, PPAP, FMEA (AIAG and VDA handbook), SPC and MSA. |
| Automotive | TISAX | Information security assessment required by many European automakers for suppliers handling their data. |
| All | Data integrity (ALCOA+) | Records stay attributable, legible, contemporaneous, original and accurate, as well as complete, consistent, enduring and available. |
Export-controlled technical data, controlled unclassified information and customer drawings under NDA can't go to just any AI service. We design automation so controlled data stays inside environments approved for it, and keep it out of public AI tools. Your export compliance and security teams set the boundary. We build inside it.
We don't certify compliance or replace your quality team's judgment. Your quality organization owns validation and approves release. Our job is to make that work straightforward, with the evidence ready when they need it.
This page is general information, not regulatory, export control or legal advice.
Yes, with a defined intended use, a risk assessment, validation or verification proportionate to that risk, and human review on any decision that affects product quality, safety or conformity.
In life sciences, if it is used in the quality system or creates or changes GxP records, generally yes. In aerospace and automotive, software that affects product acceptance or quality records needs equivalent control. The depth scales with risk: a reminder email needs far less than a tool that classifies complaints.
Where electronic records or signatures are in scope: secure, computer-generated, time-stamped audit trails, access limited to authorized people, operational and authority checks, and controls on electronic signatures.
Yes, mostly by assembling: pulling dimensional results, material certifications, process flows, PFMEA and control plans into PPAP elements or AS9102 forms, and flagging what is missing. The part submission warrant and the FAI sign-off stay with your people.
Only in environments authorized for that data. We keep export-controlled technical data and CUI out of public AI services and design around your export control and CMMC boundaries. Your compliance team decides what is in scope.
It depends on the components. Configured off-the-shelf tools typically fall in Category 4, and custom code or scripts in Category 5. We document the categorization as part of the risk assessment.
Medical devices and diagnostics, aerospace and defense, and automotive. The same principles apply to pharmaceutical GxP and other regulated manufacturing.
The first conversation is free, takes about an hour and covers one process end to end. You keep the map whether or not you hire us.