The device history record that writes itself as the line runs.
In regulated device manufacturing, every unit ships with a story the FDA can ask for: which lots went in, who built it, on what equipment, against which revision, with what test results. On paper, that story takes binders, back-offices, and weeks of review. On a modern MES it assembles itself, station by station, as the work happens. We've spent years deploying and integrating Critical Manufacturing MES in FDA-regulated plants worldwide: from the ERP interface that releases the order, to the line equipment that feeds the record, to the Kubernetes infrastructure it all runs on.
MES is where orders become devices, and devices become data.
A Manufacturing Execution System lives 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 everything that actually happened and hands the proof back up.
Every station is a gate. The record is the toll.
A released order carries its route: the ordered set of operations the device must pass through, each with its own materials, instructions, equipment, and data collection. The MES walks each serial number or lot through that route and refuses every shortcut: wrong material, expired lot, uncertified operator, missed test. Nothing advances without proof, and the proof is the eDHR.
Enforcement is built in
Paper asks the operator to do the right thing. The MES makes the wrong thing impossible: a step can't start with unverified material, an uncertified operator, or a superseded instruction revision. Compliance stops being a review activity and becomes a property of the process itself.
Genealogy runs both ways
Ask a serial number what went into it, or ask a supplier lot where it ended up. When a component recall lands, the affected-device list is a query that takes seconds, and it's exact: no over-scoping the recall to be safe, no combing through storage boxes.
Quality closes the loop
NCR, CAPA, SPC, and sampling inspection live inside 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.
The integration is where MES projects live or die.
An MES with no ERP interface is an island: orders re-typed by hand, inventory counted twice, two systems that quietly disagree. The real work of an MES program is the plumbing, and we've designed and specified it end to end: which events trigger which messages, what every field means, and what happens on the edge cases. Below is the shape of a shop-order integration we authored for a global, multi-site rollout (identifiers genericized).
Orders arrive once, complete, and filtered
Release is the trigger, wherever it comes from: planning runs, campaign processing, or manual order maintenance. Configurable rules decide which orders belong to the MES (by warehouse, by item enablement) so a plant can migrate line by line instead of big-bang. The header brings the order; the material lines bring 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. A component lot expires early or gets blocked: the MES knows before the operator scans it. A document attached to an open order gets a new revision: every affected order is notified by number, so nobody builds against yesterday's drawing.
lot · status · revision → open ordersThe edge cases are the spec
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 one-page happy path becomes a real specification when every one of these has an answer, and ours do.
rework · GTIN fallback · blank lot · defaultsNo MES is compliant out of the box. Validated deployments are.
The FDA is explicit that no vendor can sell a turnkey "Part 11 compliant system": the technical controls come from the software, and the procedural controls come from how you deploy, configure, and validate it. Critical Manufacturing MES brings the technical half in depth. We've delivered the other half: configuration, procedures, and risk-based validation, inside live FDA-regulated plants.
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. Record retention and human-readable export mean an investigator's request is a report, and audit prep stops being a scramble.
who · what · when · before/afterPart 820 production controls
The quality-system half of the equation: device master record data driving execution, device history records assembled electronically, enforced operator training and certification, and identification and traceability through every operation, the way subparts of 820 expect.
DMR → execution → DHRRisk-based validation
We validate the way the FDA now encourages: Computer Software Assurance, with rigor focused where patient safety and product quality are actually at stake. Vendor assessments against ISA-95, ISA-88, and Part 11 feed the plan, so effort lands on configuration and intended use instead of re-testing the platform.
CSA · IQ/OQ/PQ · intended useMES integration services, from the interface spec to the infrastructure.
We've carried Critical Manufacturing MES deployments through global multi-site programs: writing the requirements, building the interfaces, replacing the paper, training the plant, and running the platform underneath. That end-to-end view is the service: one team that 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 scale one validated template across plants instead of reinventing each one. We've led deployments through go-live and hypercare in regulated production, where "cutover" means 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 to prove it all: the unglamorous work that turns "paperless" from a slide into a running line.
Run the platform
MES needs infrastructure that deserves it: we build and operate the cloud, hybrid, and on-premise Kubernetes platforms underneath, with the monitoring, backup, and disaster recovery a validated system demands. Plus the support and training that keep it healthy after go-live.
The payoff shows up in the metrics a plant manager already tracks, and in a few they've never been able to see before:
- Release in hours instead of weeks. Review-by-exception on a self-auditing record replaces page-by-page DHR review.
- 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.
- One truth from floor to ERP. Inventory, order status, and yield agree everywhere, because they're recorded once, in context, at the source.
- A foundation for the next decade. OEE, SPC, IoT data, and analytics inherit clean, contextualized data from day one, so Industry 4.0 stops being a poster in the lobby.
Still building regulated product on paper travelers?
Tell us where your orders come from, what your lines look like, and where the binders live. We'll show you the path from there to a validated eDHR, and what it takes to walk it.
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