MES and electronic device history records for medical device manufacturing.
Every regulated device ships with a history the FDA can ask to see: which lots went in, who built it, on what equipment, against which revision, and with what test results. On paper, that history lives in binders and takes weeks to review. An MES builds it station by station as the work happens. We've spent years deploying and integrating Critical Manufacturing MES in FDA-regulated plants in North America and Europe, including the ERP interface that releases the order, the line equipment that feeds the record, and the Kubernetes infrastructure underneath.
Where the MES sits between the ERP and the line.
A Manufacturing Execution System sits at Level 3 of the ISA-95 stack: below the ERP that plans the business, above the equipment that does the work. The ERP says make 100 of part A. The MES decides what that means on the floor: which line, which materials, which operators, which work instructions at which revision. Then it records what actually happened and reports it back up to the ERP.
How the route is enforced at each station.
A released order carries its route, the sequence of operations the device has to pass through, each with its own materials, instructions, equipment, and data collection. The MES moves each serial number or lot through that route and blocks the usual shortcuts: wrong material, expired lot, uncertified operator, skipped test. Nothing moves forward without a record, and that record is the eDHR.
Enforcement is built in
Paper relies on the operator doing the right thing. The MES blocks the wrong thing: a step can't start with unverified material, an uncertified operator, or a superseded instruction revision. Compliance gets checked as the work happens, not afterward in review.
Genealogy runs both ways
You can ask a serial number what went into it, or ask a supplier lot where it ended up. When a component recall comes in, the list of affected devices is a query that takes seconds. It's exact, so there's no widening the recall to be safe and no digging through archived paperwork.
Quality in the same system
NCR, CAPA, SPC, and sampling inspection run in the same system as execution. A failed test doesn't file a form for someone to find later; it holds the material, opens the investigation, and links every affected order into it.
Integrating the MES with the ERP.
Without an ERP interface, an MES means orders retyped by hand, inventory counted twice, and two systems that quietly disagree. Much of the work in an MES program is this interface, and we've designed and specified all of it: which events trigger which messages, what every field means, and what happens in the edge cases. Below is the outline of a shop-order integration we wrote for a global, multi-site rollout (identifiers genericized).
Orders arrive once, complete, and filtered
Release is the trigger, whether it comes from a planning run, campaign processing, or manual order maintenance. Configurable rules (by warehouse, by item enablement) decide which orders go to the MES, so a plant can move over line by line instead of all at once. The header carries the order, and the material lines carry the full component list with quantities, scrap factors, and revisions.
release → filter → queue → MESMaster data stays in sync
Database triggers watch the lot master and item master after release. If a component lot expires early or gets blocked, the MES knows before the operator scans it. If a document on an open order gets a new revision, every affected order is notified by number, so nobody builds against an old drawing.
lot · status · revision → open ordersThe spec covers the edge cases
Rework orders that must not double-consume materials. Items with no GTIN that inherit the parent's. Blank lots that fall back to the order number. Placeholder expiration values that mean "never expires" and must never reach a label. A happy-path spec fits on one page. A real one has an answer for each of these, and ours does.
rework · GTIN fallback · blank lot · defaultsCompliance and validation.
No software is Part 11 compliant out of the box. The rule expects both technical controls, which come from the software, and procedural controls, which come from how you deploy, configure, and validate it. Critical Manufacturing MES covers the technical controls thoroughly. We've done the other half in live FDA-regulated plants: configuration, procedures, and risk-based validation.
Electronic signatures
Part 11 subpart C controls built in: unique credentialed signatures tied to enterprise identity, signature manifests showing name, date, time, and meaning (review, approval, responsibility), and signatures cryptographically linked to their records so they can't be excised or transplanted.
21 CFR 11 subpart CAudit trail everywhere
Secure, computer-generated, time-stamped audit trails on records and master data: who changed what, when, and from what value. With record retention and human-readable export, an investigator's request becomes a report you run instead of a scramble.
who · what · when · before/afterPart 820 production controls
This is the quality-system side: device master record data drives execution, device history records are assembled electronically, operator training and certification are enforced, and identification and traceability carry through every operation, as the subparts of 820 expect.
DMR → execution → DHRRisk-based validation
We validate the way the FDA now encourages, using Computer Software Assurance: the most rigorous testing goes where patient safety and product quality are at stake. Vendor assessments against ISA-95, ISA-88, and Part 11 feed the plan, so effort goes to configuration and intended use instead of re-testing the platform.
CSA · IQ/OQ/PQ · intended useWhat we do on an MES program.
We've taken Critical Manufacturing MES deployments through global multi-site programs. We've written the requirements, built the interfaces, replaced the paper, trained the plant, and run the platform underneath. That means one team can argue with the ERP analyst in the morning and the controls engineer in the afternoon.
Deploy & roll out
Site assessments, requirements, and phased rollouts that reuse one validated template across plants instead of starting over at each. We've led deployments through go-live and hypercare in regulated production, where cutover is the day the paper stops.
Integrate ERP & equipment
Shop orders, BOMs, lots, and revisions flowing from the ERP; consumption and completions flowing back; test stands, printers, scanners, and PLCs wired into the record. We write the field-level specs and build the interfaces, queues, and error handling around them.
Replace paper with eDHR
Process mapping from the current travelers, master data modeling, work instruction migration, and the validation documentation behind it. It's unglamorous work, and it's what actually gets a line running without paper.
Run the platform
We build and operate the cloud, hybrid, and on-premises Kubernetes platforms the MES runs on, with the monitoring, backup, and disaster recovery a validated system needs, and we provide support and training after go-live.
You'll see the results in metrics you already track, and in a few you couldn't measure before:
- Release in hours instead of weeks. Quality reviews the exceptions on the electronic record instead of reading the DHR page by page.
- Errors blocked at the station. Right-first-time goes up because the wrong material, revision, or operator never gets a chance to touch the unit.
- Audits become queries. Traceability, training records, and signatures are seconds away, sliced by product, lot, operator, or date.
- The floor and the ERP agree. Inventory, order status, and yield match in both because they're recorded once, in context, at the source.
- Clean data for what comes next. OEE, SPC, IoT, and analytics projects start with clean, contextualized data from day one, so Industry 4.0 stops being a poster in the lobby.
Get in touch about your MES project.
Tell us where your orders come from, what your lines look like, and where the binders live. We'll lay out what it takes to get from there to a validated eDHR.
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