The Clauses That Touch the ERP
Walk the standard and mark where your ERP carries the evidence. 5 govern control of documents and records, so routings, BOMs and travelers need revision control and retention. 4 covers purchasing and supplier evaluation.
11 preservation of product. 2 corrective action. 6 requires validation of software used in the QMS, and that includes an ERP that releases lots or holds inventory.
Writing this mapping down is also the fastest way to explain your system to an auditor.
Capabilities to Look for in an ERP or MES
Most mid-market ERPs handle the basics. The gaps show up in the specifics of device work.
- Lot and serial genealogy from raw material cert through to shipment, queryable in both directions
- Revision-controlled BOM and routing with approval workflow and effective dates
- Quality holds that block issue, shipment and invoicing until disposition
- Electronic signature and audit trail on records, aligned with 21 CFR Part 11 where records are electronic
- Approved supplier list enforced at purchase order creation
- Expiry and shelf-life controls for adhesives, sterile barrier materials and packaging
ERP, eQMS and MES: Who Owns What
Many device contract manufacturers run an ERP such as Epicor Kinetic, Infor SyteLine, Plex, NetSuite or E2 for orders, inventory and costing, and a separate eQMS such as MasterControl, Greenlight Guru, Arena or Qualio for CAPA, document control, training and audits. That split is fine as long as the interfaces are controlled: the released revision in the eQMS must be the one the ERP routing points to, and an NCR in the quality system must place an inventory hold in the ERP. Decide which system is the system of record for each record type and write it in your quality manual.
Duplicate sources of truth are where audit findings come from.
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FDA 21 CFR Part 11 Readiness Assessment
Answer 8 questions on e-signatures, audit trails, access control, and validation status to see how ready your electronic records and systems are for FDA scrutiny.
Validating the ERP Without Building a Mountain of Paper
FDA's computer software assurance guidance encourages risk-based testing over exhaustive scripted documentation. For an ERP, that means identifying the functions that carry product risk (lot status, holds, BOM revision, label data, release workflow), testing those thoroughly and recording the evidence, and doing lighter assurance on low-risk functions such as general ledger reports. Keep a validation plan, a requirements list tied to tests, and a change-impact procedure for upgrades and patches.
For SaaS ERPs, review the vendor's release notes each cycle and regression-test your critical functions before you accept a new release into production.
When Your Current ERP Is Good Enough
Not every shop needs to replace its system. If you run a few part families, lot traceability is already enforced by your travelers and receiving process, and your eQMS handles documents and CAPA, a well-configured ERP with disciplined procedures can satisfy an ISO 13485 audit. Replacement is worth considering when traceability depends on spreadsheets or tribal knowledge, when you cannot produce a lot genealogy in under an hour, when holds are not system-enforced, or when customers' supplier audits keep raising the same finding.
Fix the process first; software does not repair a weak procedure.
Frequently asked questions
Does ISO 13485 require a specific ERP system?
No. The standard is system-neutral. It requires controlled documents and records, traceability, supplier control, nonconformance handling and validation of software used in the quality system. Any ERP, eQMS or even paper system can comply if it is controlled and validated for its intended use.
Does my ERP need to be validated for FDA and ISO 13485?
If it is used in the quality system or affects product quality, such as lot status, holds, BOMs and release, yes, but validation should be risk-based and proportional. Focus testing on the functions that carry product risk and keep objective evidence. FDA's computer software assurance approach supports less scripted documentation for low-risk functions.
Do I need separate ERP and eQMS software?
Not always. Smaller shops sometimes run quality records inside the ERP. Separate eQMS tools offer stronger document control, CAPA and training workflows. Either works if the system of record for each record type is clear and the interfaces, such as holds and released revisions, are controlled.
Netray works with the ERP you already run, adding private AI and query tools for lot genealogy and audit evidence rather than asking you to replace the system of record.