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Industry · Pharma & medical devices

Compliance is not extra work — it is built into the system

Pharma and medical device manufacturing is heavily regulated, and every batch needs complete and truthful records. Aiiiss builds compliance into the production process, so records are created as production happens.

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Industry challenges

What makes Pharma & medical devices hard

  • Strict regulation

    Records must be truthful, complete and traceable, and stand up to audits.

  • Heavy paper records

    Filling in, reviewing and archiving batch records takes a lot of people.

  • No room for dispensing errors

    Any deviation in weighing and dispensing affects product quality.

  • Scattered test data

    Lab data is hard to link to production data.

Our approach

How Aiiiss helps

Weighing and dispensing

Weighing data is collected automatically and materials and quantities are checked against the recipe.

Recipe design and execution

Recipe versions are controlled and production strictly follows the approved recipe.

Compliance management

Critical steps require electronic signatures and every operation has an audit trail.

Electronic batch records

Production records are created as you go, with less manual entry and review.

Data tracking and monitoring

Material, equipment and environmental data are tracked throughout, with deviations flagged in time.

Lab integration

Production inspections can be sent to LIMS and results are written back automatically.

Recommended

Recommended products and solutions

Every product can be purchased on its own. Start with what you need most and add the rest later.

Manufacturing Execution System (MES)End-to-end work order tracking · Barcode reportingLearn more → Quality Management & Traceability (QMS)Four inspection checkpoints · SPC process controlLearn more → Laboratory Information Management (LIMS)End-to-end sample management · Electronic records and signaturesLearn more → System & Data SecurityFine-grained permissions · Audit trail and e-signaturesLearn more → End-to-end quality traceabilityIncoming, in-process, lab and outgoing in one chainLearn more → Closed-loop field serviceRepair requests, dispatch, parts and billing in one flowLearn more →

Next step

See a demo built around your industry

We will walk you through the typical Pharma & medical devices scenarios.

Request a demo → Find your starting point