# ISO 13485 ERP Requirements for Medical Device Contract Manufacturers > Source: https://netray.co/resources/iso-13485-erp-requirements-contract-manufacturers > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Knowledge Base ## Short answer What ISO 13485 and FDA QMSR actually require of an ERP at a medical device contract manufacturer: records, traceability, change control and software validation. ## Category erp-general ## Content **Intro:** ISO 13485 does not certify ERP software, but it does set requirements your ERP must help you meet: controlled records, lot and serial traceability, controlled changes to bills of material and routings, nonconforming product control, supplier approval and software validation for any system that affects product quality. Since the FDA's Quality Management System Regulation took effect in February 2026 and incorporates ISO 13485 by reference, the same discipline applies to US device work. The practical test is whether your ERP can reproduce, for any shipped lot, exactly which material, process, equipment, people and records produced it. **Sections:** #### The Clauses That Touch the ERP **Body:** Walk the standard and mark where your ERP carries the evidence. Clause 4.2.4 and 4.2.5 govern control of documents and records, so routings, BOMs and travelers need revision control and retention. Clause 7.4 covers purchasing and supplier evaluation. Clause 7.5.1 requires production control, 7.5.8 identification, 7.5.9 traceability, and 7.5.11 preservation of product. Clause 8.3 governs nonconforming product and 8.5.2 corrective action. Clause 4.1.6 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 **Body:** Most mid-market ERPs handle the basics. The gaps show up in the specifics of device work. **Bullets:** - 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 **Body:** 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. #### Validating the ERP Without Building a Mountain of Paper **Body:** 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 **Body:** 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. **Cta:** 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. **Faq:** #### Does ISO 13485 require a specific ERP system? **Answer:** 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? **Answer:** 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? **Answer:** 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. ## Related Slugs - healthcare-medical-device-erp - erp-audit-trail-configuration-guide - syteline-quality-management - ai-audit-trails-compliance-guide - erp-data-quality-framework ## Search terms ISO 13485 ERP requirements, ERP for medical device contract manufacturer, ISO 13485 software validation ERP, FDA QMSR ERP, best ERP for ISO 13485 shop, eQMS vs ERP medical device --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json