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Regulatory & Customer Compliance

Prove Every Build Was Done Right, Instantly

Auditors, regulators, and customers all want the same thing: proof. FactoryLogix captures that proof automatically as products move through your factory, so every approval, every operator action, and every configuration change becomes part of a permanent record, not a report someone has to reconstruct after the fact.

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Compliance Shouldn't Mean a Week of Digital Archaeology

Most manufacturers already pass their audits. The question is what it costs to get there. When an auditor or a customer asks for proof of how a product was built, the evidence usually exists, scattered across paper travelers, spreadsheets, sign-off sheets, and disconnected quality systems, and someone has to go find it, reconcile it, and hope nothing is missing. 

Common challenges include:

  • Audit and customer requests trigger days of digging through paper, spreadsheets, and disconnected systems.

  • Device history records are assembled after the fact instead of automatically as work happens.

  • ITAR-controlled and customer-restricted data relies on manual access processes instead of enforced controls.

  • Process and routing changes reach validated production before their impact can be tested

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Compliance Built Into Every Build, Not Bolted On After

FactoryLogix captures the evidence of a properly controlled process as a byproduct of running production, not as a separate project. Every approval, signature, and configuration change is recorded automatically, so audits and customer requests get answered from data you already have, not data you have to go build.

Approvals, signatures, and process history are captured at the point of work, in sequence, as the product is built. Approvals, signatures, and process history are captured as work happens, creating a complete, accurate record that reflects exactly how the product was built.

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Explore the Features and Benefits

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Audit Trail

Answer Any Audit Question in Minutes, Not Days

Every approval, document revision, and operator action on the floor is captured automatically in a digital audit trail, so the evidence of a properly controlled process exists before an auditor ever asks for it. Electronic signatures confirm who did what and when, meeting FDA 21 CFR Part 11 and other stringent regulatory standards.

  • System-wide digital audit trail across engineering and production

  • Electronic signature enforcement tied to individual accountability

  • Instant retrieval for internal reviews, customer requests, or regulatory inspections

Built for Confidence, Not Just Compliance

Control Costs, Protect Quality, and Simplify Compliance

Compliance touches every part of the operation, not just the quality department. When the evidence builds itself, the benefit shows up in audit prep time, recall scope, and how fast a new product or revision can qualify, not just in the quality department's workload.

Risk Mitigation

Catch a compliance gap or quality escape before it reaches a customer, not after.

Continuous Improvement

Every audit and every nonconformance becomes data for the next improvement, not a closed file.

Total Product & Process Traceability

See the full build history of any unit, from incoming material to shipment, in seconds.

Faster Validation and Qualification

A GAMP5-aligned platform and Simio-tested process changes mean new lines and revisions qualify faster.

Protect Your Brand

Contain a recall to the units genuinely affected instead of the entire product line.

Single Source of Truth

One record regulators, customers, and your own team can rely on, instead of competing spreadsheets.

Compliance Across Every Regulatory Environment

Purpose Built for the Toughest Compliance Environments

Compliance looks different depending on the industry, regulator, and customer. FactoryLogix supports the requirements that govern how products are built, documented, controlled, and verified, giving manufacturers the flexibility to meet stringent compliance demands without adding separate processes or systems. 

Know What Happened. Prove What's Happening. Predict What's Next.

FactoryLogix captures the evidence of a properly controlled process as products move through the factory, so audits, recalls, and customer questions get answered from real build data instead of reconstructed after the fact. Paired with Simio, manufacturers can also see how a proposed change plays out ahead of time, so decisions get made with data instead of a best guess.

Make Every Audit a Formality, Not a Fire Drill

The digital audit trail, eDHR, and revision control FactoryLogix builds automatically turn audit and customer compliance requests into a lookup, not a project. And because Simio can run a change through its paces first, a schedule shift or new routing gets tested on a model instead of on a floor that's supposed to stay in a controlled state.

Answer Audits with Confidence

Passing an audit is good. Passing it quickly, completely, and with evidence already in hand is what builds trust.

Reduce the Cost of Compliance

Automated compliance eliminates the hours of digital forensics and manual report building that compliance used to require.

Related Insights & Resources

Practical guidance on building audit-ready evidence, automating compliance reporting, and keeping traceability intact across every site.

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FAQ's

The questions quality, compliance, and operations leaders ask most about proving regulatory and customer compliance with FactoryLogix.

The audit trail is captured automatically as operators complete their normal work. Approvals, document versions, and electronic signatures are recorded in the background, so there's no separate logging step and no impact on production pace.

Ready to Stop Rebuilding Evidence After the Fact?

See how manufacturers are cutting audit prep time, tightening ITAR and access control, and staying validation ready without slowing down the floor.

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