--- title: "Electronic Device History Record (eDHR) Software | Tulip" description: "Electronic device history record software that captures data as work happens, enforces in-process quality checks, and accelerates batch release with audit-ready traceability." url: "https://pr-1391.tulip-co.tulipecointra.net/traceability-and-compliance/device-history-records/" lang: "en" --- Electronic Device History Record Software # 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. [Request a Demo](https://pr-1391.tulip-co.tulipecointra.net/contact-sales/) Logos: RFK racing icon, DMG Mori icon, Vertex icon, SBD icon, Smith + Nephew icon, Laderal icon, Terex icon, Mack Molding icon, AstraZeneca icon, Saint-Gobain icon, Avon icon 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. ## Automate eDHR traceability and FDA compliance 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** Error-Proof Assembly ### Enforce Standard Operating Procedures During Every Build 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. ![Life sciences digital guidance safety check](https://tulip.widen.net/content/rhdtm1pfmr) [See how Tulip supports operator guidance](https://pr-1391.tulip-co.tulipecointra.net/digital-guidance.md) **AI-Assisted Authoring** 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](https://tulip.widen.net/content/lsw1ks5ts7) [See what Tulip AI can build](https://pr-1391.tulip-co.tulipecointra.net/platform/authoring.md) **Native Integrations** 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](https://tulip.widen.net/content/0owwds7unt) [Browse connectors and integrations](https://pr-1391.tulip-co.tulipecointra.net/platform/connectors-integrations.md) **Electronic Signatures** 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](https://tulip.widen.net/content/ryrgteuxpc) [See how Tulip supports compliance](https://pr-1391.tulip-co.tulipecointra.net/traceability-and-compliance.md) **Version Control and Approvals** 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](https://tulip.widen.net/content/eqmx4ehftu) [See how Tulip governs change](https://pr-1391.tulip-co.tulipecointra.net/platform/scalability-governance-insights.md) 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. **Outset Medical** ![Outset medical production facility](https://tulip.widen.net/content/gs78isawlh) ### 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 Vidal**, Sr. Director Manufacturing/Plant Manager, Outset Medical [Hear Outset Medical's story](https://pr-1391.tulip-co.tulipecointra.net/webinars/outset-medical-a-digital-transformation-success-story-how-to-build-an-agile-frontline-in-weeks-not-years/) **Smith+Nephew** ![Smith+Nephew production facility](https://tulip.widen.net/content/szpe9bkmx4) ### Zero documentation non-conformances on eDHR lines over five months 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." > > — **Sarath Krishnaswami**, VP of Operational Technology, Smith+Nephew [Hear Smith+Nephew's approach](https://pr-1391.tulip-co.tulipecointra.net/webinars/smith-and-nephews-agile-digital-transformation-in-med-device-manufacturing/) **Laerdal Medical** ![Laerdal Medical kitting process](https://tulip.widen.net/content/nyuhhd9in1) ### Increased assembly process efficiency 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. ## Questions? We have answers! ### What is an electronic device history record? 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. ### How does Tulip support 21 CFR Part 11 compliance? 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. ### How does Tulip integrate with our existing QMS and ERP? 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. ### How are changes validated in Tulip? 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. ### How quickly can a medical device manufacturer deploy an eDHR? 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. ## 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. [Book a Demo](https://pr-1391.tulip-co.tulipecointra.net/contact-sales/) [Take a Virtual Tour](https://pr-1391.tulip-co.tulipecointra.net/tec-virtual-tour/) ![DisrFactory Illustration](https://tulip.widen.net/content/8uc6gjw9qo)