Traceability & Compliance Solutions
Automated traceability for audit-ready operations
Stop reconstructing history. Tulip automatically captures material genealogy, electronic signatures, and machine data as production runs. Your compliance records are built instantly, saving thousands of manual documentation hours.
Why teams choose Tulip for quality management
Eliminate transcription errors with automatic data capture
Manual data entry inevitably leads to missing information and compliance risks. Tulip connects directly to your shop floor equipment to log precise measurements, material scans, and operator actions automatically. The quality record is built invisibly as the work gets done.
- Pull objective data directly from scales, barcode scanners, and smart tools
- Enforce process steps to guarantee accurate data collection before moving forward
- Enrich batch records with automatic timestamps, sensor readings, and photos
- Capture compliant electronic signatures exactly where the action happens
Map the complete genealogy of every product
Stop digging through disconnected systems to find the root cause of a defect. Tulip creates a complete digital thread linking every raw material, machine, and operator to the final product. When an issue arises, you can trace the exact source in minutes instead of days.
- Track raw materials and sub-assemblies through every production stage
- Link specific operator actions and tool data to individual serial numbers
- Isolate affected batches instantly to minimize the scope of potential recalls
- Visualize complete production history across multiple lines and facilities
Generate compliant digital history records organically
Preparing for an audit should not require a dedicated team of document chasers. Tulip automates the creation of electronic batch records (eBR) and device history records (eDHR), ensuring you always have accurate and compliant documentation ready for review.
- Generate complete eBR and eDHR reports without manual compilation
- Enforce strict CFR Part 11 compliant electronic signatures and approvals
- Prevent out-of-spec processes from proceeding with automatic workflow gating
- Access secure historical data immediately for fast and painless auditor reviews
Edge and Open Connectivity
Automate data capture to eliminate manual transcription errors. Native edge connectivity pulls objective readings directly from smart tools and machines, while open APIs sync critical compliance data seamlessly with your ERP and QMS.
Compliant Electronic Signatures
Enforce strict regulatory requirements directly within your operator workflows. The platform features native, role-based electronic signatures that comply with 21 CFR Part 11 and EU GMP Annex 11 to securely record critical sign-offs.
Contextual Audit Trails
Build comprehensive digital history records natively as production runs. The system automatically links material scans, equipment states, and time-stamped operator actions into a unified, audit-ready electronic batch record.
Scalability and Governance
Enforce strict GxP and ITAR compliance across your facility. The platform provides built-in version control, role-based access permissions, and approval workflows to ensure only authorized personnel can execute validated processes.
How manufacturers use Tulip for traceability and compliance
Electronic Batch Records
Enforce standardized workflows and collect batch data in real time. Catch deviations as they happen and shorten the review cycle standing between you and release.
Electronic Device History Records
Build complete, searchable device history records as the device is assembled. Answer material, personnel, and equipment traceability questions in minutes.
Equipment Logbooks
Replace paper logbooks with entries carrying images, sensor data, and timestamps. Filter the log to pinpoint an issue or demonstrate compliance on the spot.
Line Clearance Software
Guide operators through changeover with dynamic SOPs and document each step as it's completed. Shorten changeovers and keep the clearance record audit-ready.
Weigh and Dispense
Connect directly to scales so the dispensed weight lands in the record as it was measured. Verify quality at each stage to keep batch variation from reaching production.
Genealogy and Traceability
Capture every component, operator action, and machine reading as a product moves through production. Trace a quality event back to its source without reassembling the history first.
Don't just take our word for it...
Hear from quality and operations teams running regulated production on Tulip today.
We've had several AS9100 audits recently. Tulip helps with audit readiness by giving us traceability across production and quality, and it gives us a practical way to address findings as they come up.
One of our biggest challenges that we implemented is our eDHR. So now people can go dive in and check everything they want, like line clearances, traceability, materials, every transaction that we are doing, people or stakeholders can consult them in there.
Know what happened, and be able to show it
Request a demo to see how Tulip builds material genealogy, electronic records, and audit trails into the workflows your operators already run.