Automate DHR compliance. Release devices faster.
Build FDA 21 CFR Part 820 and ISO 13485 compliance directly into execution. Automatically compile device history records in real-time as the build progresses, ensuring every unit is audit-ready without the manual overhead.
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.
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.
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.
Tulip’s composable platform integrates data capture directly into your discrete assembly processes. Operators generate fully traceable, immutable electronic Device History Records (eDHR) simply by completing their work, eliminating post-production review bottlenecks and ensuring constant audit readiness for ISO 13485 and 21 CFR Part 820.
Error-Proof Assembly
Make traceability an automatic byproduct of device assembly. Tulip guides operators through complex builds with step-by-step applications that enforce critical data collection like UDI scanning, torque values, and lot numbers. This ensures operators only advance when all quality and traceability requirements are met.
AI-Assisted Authoring
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.
Native Integrations
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.
Electronic Signatures
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.
Version Control and Approvals
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.
Customer stories
See how manufacturers use Tulip to guide operators and capture what happens at every step.
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."
Smith+Nephew built a composable architecture supporting regulated manufacturing at a global scale. They achieved zero documentation non-conformances on their eDHR lines over a five-month period and increased sterilization chamber utilization by roughly 30%.
"If all we've done by bringing Tulip in is getting more modern with regard to risk-based validation, then that's already transformative for us – let alone everything else we’ve accomplished."
Laerdal Medical digitized critical workflows to ensure consistent quality across their life-saving training devices. They increased overall assembly process efficiency and eliminated defects and omitted parts resulting from human error.
An electronic device history record (eDHR) is a digital, immutable log of every material, operator action, and machine reading tied to a specific serialized medical device or lot. Where paper records require manual data entry and end-of-batch review, an eDHR captures data automatically at the point of work. It enforces required verifications, prevents skipped steps, and timestamps every entry, creating an audit trail that closes itself when the build finishes.
Tulip is built for GxP environments, incorporating controls for electronic records and signatures. The platform provides an immutable audit trail, electronic signature controls, and access management through identity providers. Every app, agent, and automation shares this security model, ensuring that compliance is inherited by design.
Tulip connects to existing systems like ERP, QMS, and PLM through pre-built connectors and open APIs. This structure pulls the latest work orders, BOMs, and inspection plans down to the station, and pushes completion data and deviations back up. The integration architecture maintains clear system-of-record boundaries while surfacing contextual data to operators.
Tulip supports a risk-based Computer Software Assurance (CSA) approach, aligning with FDA guidance. The platform's separation of development, validation, and production environments allows teams to validate a specific app or use case based on its intended use. Changes to an individual app do not trigger re-validation of the entire system.
Deployment timelines typically run from a few weeks to several months, depending on integration complexity and validation requirements. Manufacturers often start with a single bounded use case, validate one app, and expand from there. By taking an iterative approach, teams can prove value and train operators before rolling the system out broadly.
See how manufacturers build error-proofed workflows, connect the tools at the station, and accelerate batch release with automated data capture.