Electronic Device History Record Software

Embed compliance into execution and accelerate batch release

Capture operator actions, machine readings, and electronic signatures directly at the point of work. The record closes itself as the build progresses, and completed units move through quality review based on exceptions rather than manual audits.

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WHY ELECTRONIC DEVICE HISTORY RECORDS MATTER

Paper-based traceability is costing you yield and speed every day

  • Traceability becomes a reconstruction project before every audit

    When the record depends on manual paperwork, proving compliance requires weeks of assembly before an inspection. Teams spend their time hunting down missing signatures and correcting transcription errors, and batch release waits on the paperwork to catch up.

  • Quality escapes travel through multiple stations undetected

    A paper process checks the work at final inspection, so a missed step or a mistyped measurement becomes a defect that travels down the line. You usually pay for it as rework and scrap, or occasionally as a recall investigation.

  • Validation overhead stalls continuous improvement

    Making a process change on traditional systems requires full revalidation, and testing every minor update consumes engineering capacity. Lean initiatives stall when the cost of approving a change outweighs the benefit of making it.

How Tulip automates traceability, enforces quality, and governs change

Tulip's composable platform embeds data capture directly into guided workflows, so operators generate an immutable device history record simply by doing the work. The platform connects directly to the tools and systems at the station, capturing equipment readings and managing version control automatically.

Review by Exception

Accelerate Release Cycles Through Automated QA

A Review by Exception model flags only the records that require human review, letting complete and in-spec records proceed. Tulip compares collected measurements against expected tolerances automatically, routing deviations for disposition immediately. Quality teams focus on resolving exceptions instead of reviewing complete paperwork.

Review by Exception

AI-Assisted Authoring

A PDF Becomes a Draft App in Seconds

Upload a PDF procedure and Tulip AI Composer extracts the steps, images, and data-collection points, proposing a structure you review before it gets built[cite: 1, 6]. Start from one of your own templates so your data model comes with it. Refine the draft, assign approval gates, and then publish.

DMG Mori supervisors reviewing nonconformance

Native Integrations

Tools and Systems Feed the Record Directly

Connect digital calipers, torque tools, and sensors to capture readings without operator typing. Pull work orders from ERP and bills of materials from PLM so the floor always reflects current engineering intent. Machines connect over OPC UA and MQTT.

Connected devices to support quality

Electronic Signatures

Compliance Built Into Execution

Tulip captures 21 CFR Part 11 compliant electronic signatures directly within the workflow. Operators authenticate to approve a step or acknowledge a deviation, and the system logs the user, timestamp, and action in a centralized audit trail. A missed signature becomes impossible to advance past.

Scanning QR code for complete traceability

Version Control and Approvals

No Revision Ships Without a Signature

Every app is version controlled, and only published versions run at a station. Assign approvers and each new version needs their electronic sign-off before it deploys. A revision reaches the station once the job in progress finishes, keeping the process stable.

Quality dashboard log

Customer stories

What leading medical device manufacturers achieve with Tulip

See how manufacturers use Tulip to guide operators and capture what happens at every step.

93% reduction in QA review time, 70% reduction in defects

Outset Medical deployed a validated eDHR from a greenfield facility in nine months, reducing QA review time by 93% through a Review by Exception model. The deployment eliminated missing signatures entirely and cut defects by 70%.

"Before, tracking a defective component could take days. Now, we can trace an issue back to the exact moment and operator—within minutes."

Hector VidalSr. Director Manufacturing/Plant Manager, Outset Medical
Hear Outset Medical's story

Questions? We have answers!

Turn compliance into a competitive advantage

See how manufacturers build error-proofed workflows, connect the tools at the station, and accelerate batch release with automated data capture.

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