Launch new devices and programs faster, with audit-ready records
Capture DHRs as work happens, cut QA review, and roll out approved process changes.
Device makers are launching more products under closer scrutiny, and every process change carries audit risk. Keeping pace takes records captured at the point of work and change control that doesn't stall each improvement.
Tulip is a composable frontline operations platform used to implement a composable MES. It works alongside the systems you already run, so quality and operations teams can digitize the processes those systems don't cover.
Operator actions, machine readings, inspection results and electronic signatures are captured at the point of work, each attributed and time-stamped. Review by exception points QA at the records that need attention, so release waits less on manual checks.
Step-by-step workflows enforce required verifications and keep operators from skipping steps, whoever is on shift. Approved revisions reach the production floor as a new version, so operators build to the current process.
Inspection steps, error-proofing and conditional gates sit inside operator workflows, so defects surface at the station where they happen. Deviations are flagged and resolved right there, with the production data engineers need for root cause analysis.
Lot numbers, expiry dates and supplier data are recorded as materials are used, with shelf-life alerts before an expired lot reaches the line. Genealogy runs from incoming material to finished goods release, so an investigation starts from data.
Training requirements are built into the workflow, and an operator's certification status is checked before they start a step. Training records are captured automatically with time stamps and electronic signatures, ready when an auditor asks.
Follow work orders through production with dashboards for WIP, cycle time and throughput. Andons and alerts send problems to the right person during the shift, well before they show up in an end-of-shift report.
Tulip gives device makers faster process changes, records captured at the station and Part 11 controls built in, whether they're weighing it against a legacy MES, an eQMS-based eDHR, a low-code tool not built for manufacturing, or paper.
When a new device launches or a new OEM program lands, engineers and quality teams author the workflows themselves, and AI Composer can turn an existing SOP into a first version for review. Each change goes through approvals and change control before it reaches production, and only what changed is touched.
Guided workflows capture DHR entries at the point of work, with device connections, conditional logic and error-proofing, so data isn't keyed in after the fact. Your QMS stays the system of record for documents and CAPA, while eDHR, quality checks, training and production run on one platform.
Electronic signatures, an audit trail and user-attributed, time-stamped records are built into the DHR, ready for IT and Quality review. For teams working under 21 CFR Part 11, Tulip's ER/ES functionality is Part 11 and Annex 11 compliant, on a qualified platform with validation documentation for each LTS release.
Outset Medical, which makes dialysis technology, implemented Tulip for MES, including eDHR, at a greenfield site in less than six months.
"We have so much data that we can analyze and predict how our process is going, and we can catch errors or mistakes or defects much sooner in the process."
Smith+Nephew replaced paper documentation and siloed systems with digital eDHRs, bringing IT, OT and Quality under a shared governance model. At its Costa Rica site, it digitized operations to cut inventory and warehouse space.
"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"
Medical device manufacturers generally need software that captures device history records as work happens, supports a risk-based approach to validation, and connects to the MES, eQMS, ERP and PLM they already run. Tulip is a composable frontline operations platform used to implement a composable MES. Most teams start with one bounded use case, such as a single paper record or assembly process, validate it, and expand from there.
Look for electronic device history records captured at the point of work, electronic records and signatures that stand up to 21 CFR Part 11 review, validation effort proportionate to risk, and a way to change one process without revalidating the whole system. Tulip covers these on one platform, and it can work alongside an existing MES to digitize the processes that MES doesn't support.
DHRs usually get rebuilt because they're filled in after the work, on paper or in forms disconnected from the process. Capturing operator actions, machine readings, inspection results and electronic signatures at each step, attributed and time-stamped, means the record is typically complete when the unit is. In Tulip, the eDHR closes as production finishes and is ready for QA review.
QA review slows release when reviewers have to check every field of every record by hand. Review by exception points reviewers at the records that need attention, because the checks and signatures were captured in the workflow as the work happened. Outset Medical saw a 93% reduction in QA review for finished goods release after moving to a Tulip eDHR.
A risk-based approach, such as FDA's Computer Software Assurance guidance, scales validation effort to the risk a change carries. Tulip supports that approach: changes to individual apps don't trigger revalidation of the entire system. Each change still goes through approvals and change control before it reaches production.
FDA's Quality Management System Regulation aligns US requirements with ISO 13485 and puts more weight on risk management, documented processes and electronic records. Manufacturers updating their quality systems are looking for digital workflows that capture that documentation during production. Tulip helps customers comply with 21 CFR Part 820 and ISO 13485, with built-in change control and electronic records.
Defects found at final inspection have often passed through several stations already. Building inspection steps, error-proofing and conditional gates into operator workflows moves those checks upstream to the station. In Tulip, deviations are flagged and resolved at the station, and the data feeds root cause analysis.
When process knowledge lives in experienced operators' heads, training tends to run long and quality can vary by shift. Guided work instructions with required verifications put that knowledge at the station, and certification checks keep operators off steps they aren't yet qualified for. Training records are captured as part of the work.
New lines tend to reach validated production faster when engineering intent turns into a production workflow quickly and validation starts small. Starting with one bounded use case and validating one app at a time keeps each step manageable. On Tulip, a first use case goes live in weeks once it clears your approvals, and Outset Medical stood up a new line in four months.
Yes. Tulip complements an existing MES by digitizing the processes it can't support and connecting data that doesn't flow today. Your eQMS stays the system of record for documents, CAPA and quality events, while Tulip captures the record during production. Open, API-based integrations with ERP, QMS and PLM keep each system's role clear.
Tulip is delivered as a qualified platform, with validation documentation for each LTS release, and its GxP version was developed under the GAMP 5 framework within an ISO 9001:2015 quality management system. Its electronic record and electronic signature functionality is 21 CFR Part 11 and Annex 11 compliant, with an audit trail, electronic signatures and access management. You validate your apps to their intended use, and the documentation is available for IT and Quality to review during an evaluation.
A practical place to start with AI in regulated production is authoring, where people review everything AI produces before it's used. Tulip's AI Composer turns existing SOPs and PDFs into a first working app, so expert knowledge reaches the floor sooner, and every app goes through approvals before it reaches production. Operational data isn't retained by LLM providers or used to train their models.
See how device and diagnostics manufacturers get product out the door with eDHRs, guided assembly and in-process quality checks.