# Medical Device ERP Fit Assessment: Score Your System Against FDA and ISO 13485 Requirements > Source: https://netray.co/tools/medical-device-erp-fit-assessment > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Free Tools ## Short answer Score how well your current or shortlisted ERP supports medical device manufacturing requirements including DHR generation, lot traceability, Part 11 controls, CAPA, and UDI submission. ## Category erp-migration ## Tool **Kind:** assessment **Questions:** #### Can your ERP assemble a complete Device History Record from production transactions? **Help:** A compliant DHR must prove each unit or lot was manufactured per the Device Master Record, including materials, labor, equipment, and acceptance activities. **Options:** ##### No DHR capability - records are assembled from paper travelers and binders **Score:** 0 ##### Partial - ERP holds material and labor data, quality records live elsewhere **Score:** 1 ##### ERP builds most of the DHR but final compilation and review are manual **Score:** 2 ##### ERP generates a complete, reviewable electronic DHR per unit or lot with electronic release **Score:** 3 #### How fast can you trace a suspect lot forward to every shipped customer and backward to every raw material? **Help:** FDA and notified bodies commonly expect full bidirectional traceability during an inspection with minimal delay. **Options:** ##### Days of manual research across spreadsheets and paper **Score:** 0 ##### Several hours, requiring help from multiple departments **Score:** 1 ##### Under an hour using standard ERP inquiries plus some manual joins **Score:** 2 ##### Minutes, from a single ERP trace screen or report covering both directions **Score:** 3 #### Does your ERP meet 21 CFR Part 11 requirements for electronic records and signatures? **Help:** Look for immutable audit trails, signature manifestation with meaning, record retention, and no ability for users to delete transaction history. **Options:** ##### No audit trail on critical records and no electronic signature capability **Score:** 0 ##### Basic change logging only, signatures still captured on paper **Score:** 1 ##### Audit trails on most master data with e-signatures on a few transactions **Score:** 2 ##### Full audit trail, meaning-bearing e-signatures, and validated retention across QMS transactions **Score:** 3 #### How is engineering change control and revision effectivity handled? **Options:** ##### Changes are emailed and manually applied to BOMs with no formal record **Score:** 0 ##### ECO process exists on paper or in a separate system, ERP is updated afterward **Score:** 1 ##### ERP tracks BOM revisions but effectivity dates and approvals are managed outside **Score:** 2 ##### Closed-loop ECO in ERP with approvals, effectivity dates, and automatic DMR linkage **Score:** 3 #### Are nonconformances and CAPA connected to production, supplier, and complaint data? **Options:** ##### CAPA lives entirely in spreadsheets with no link to lots or suppliers **Score:** 0 ##### A separate QMS holds CAPA with manual copying of lot and supplier detail **Score:** 1 ##### ERP records nonconformances, CAPA is managed in an integrated external QMS **Score:** 2 ##### Nonconformance, CAPA, and effectiveness checks all reference live ERP lot and supplier records **Score:** 3 #### Does the system enforce approved vendor list and incoming inspection controls? **Help:** Purchasing from an unapproved supplier or receiving without inspection are two of the most common Part 820 supplier control findings. **Options:** ##### No AVL enforcement - buyers can purchase from any supplier **Score:** 0 ##### AVL exists as a reference document, enforcement depends on the buyer **Score:** 1 ##### ERP warns on unapproved suppliers but allows override without documented justification **Score:** 2 ##### ERP blocks unapproved supplier and part combinations and forces receiving inspection disposition **Score:** 3 #### Do you have a computer system validation package and a revalidation strategy for updates? **Help:** Cloud ERP releases arrive on the vendor schedule, so a repeatable regression and revalidation approach matters more than a one-time IQ/OQ/PQ binder. **Options:** ##### No formal validation documentation exists for the ERP **Score:** 0 ##### An original IQ/OQ/PQ package exists but has not been maintained through upgrades **Score:** 1 ##### Validation is current but revalidation is a manual, multi-week effort each release **Score:** 2 ##### Risk-based validation with automated regression scripts executed each vendor release **Score:** 3 #### How is UDI data managed and submitted to GUDID or EUDAMED? **Options:** ##### UDI attributes are maintained in spreadsheets and submitted manually **Score:** 0 ##### Some UDI fields live in ERP but submission files are built by hand **Score:** 1 ##### ERP holds all UDI attributes and exports a file that needs manual cleanup **Score:** 2 ##### ERP is the single source for UDI with validated submission and label printing **Score:** 3 #### Can complaint handling and post-market surveillance reach back to lot-level manufacturing data? **Options:** ##### Complaints are tracked separately with no manufacturing linkage **Score:** 0 ##### Complaint records reference a serial number but investigation data is gathered manually **Score:** 1 ##### Complaint investigators can query ERP lot data with help from operations **Score:** 2 ##### Complaints link directly to DHR, supplier lots, and process parameters for trend analysis **Score:** 3 #### Does the system control expiry dating, quarantine status, and FEFO issue for controlled materials? **Options:** ##### No system-level expiry or hold control - managed with physical tags **Score:** 0 ##### Expiry dates are recorded but issuing does not enforce FEFO or block expired stock **Score:** 1 ##### Expiry and hold statuses are enforced in the warehouse but not in planning **Score:** 2 ##### Full status control with FEFO allocation, automatic quarantine, and shelf-life aware planning **Score:** 3 **Bands:** #### High regulatory risk - your ERP is not carrying the compliance load **Min:** 0 **Max:** 39 **Verdict:** Your ERP is functioning as an accounting and materials system while your quality system runs on paper and spreadsheets. In a Part 820 or ISO 13485 audit this shows up as slow traceability responses, incomplete device history records, and undocumented supplier controls. The remediation effort is significant but the highest-value fixes are narrow and well understood. **Recommendations:** - Run a mock recall this quarter and time how long full bidirectional traceability actually takes - the number will anchor your business case. - Prioritize lot and serial genealogy in the ERP before any other module, since DHR, complaints, and CAPA all depend on it. - Stand up enforced approved vendor list controls and receiving inspection disposition, which are among the most cited supplier control gaps. - Write a risk-based validation plan now rather than after implementation, so requirements and test scripts are built together. - Evaluate whether your current platform can realistically close these gaps or whether a device-capable ERP is the faster path. #### Partial fit - core transactions are solid, compliance layers are bolted on **Min:** 40 **Max:** 59 **Verdict:** You have credible material and production control but quality-critical records still cross system boundaries by hand. That manual bridging is where audit findings and recall response delays originate. Closing two or three specific gaps usually moves you into defensible territory without a full replatform. **Recommendations:** - Identify every point where a person retypes data between ERP and the quality system, and close the highest-volume two first. - Move electronic signature and audit trail coverage onto the transactions that appear in your DHR, not just master data. - Automate UDI attribute maintenance in ERP so labeling and GUDID submissions share one validated source. - Build a repeatable regression test set so vendor releases do not trigger a multi-week revalidation scramble. - Document the current state gaps formally so they become a managed remediation plan rather than audit surprises. #### Good fit - refine execution and validation discipline **Min:** 60 **Max:** 79 **Verdict:** Your ERP genuinely supports device manufacturing and most compliance evidence is produced by the system rather than by people. Remaining risk is concentrated in change management, revalidation cadence, and the depth of post-market linkage back to manufacturing data. Focus on making the good design survive upgrades and growth. **Recommendations:** - Automate regression testing against your validated configuration so each vendor release is a controlled event. - Extend complaint and post-market records to link directly into DHR and supplier lot data for real trend analysis. - Tighten shelf-life and quarantine control into planning so expiring stock is visible before it becomes scrap. - Add exception dashboards for unapproved supplier attempts, override usage, and skipped inspections. - Review your validation scope annually against a risk assessment rather than revalidating everything by default. #### Strong fit - protect and extend what you have built **Min:** 80 **Max:** 100 **Verdict:** Your ERP is producing compliance evidence as a byproduct of normal operations, which is the goal. At this level the opportunity shifts from remediation to leverage: using the clean, structured data you already capture to reduce investigation time, predict quality escapes, and shorten release cycles. Guard against configuration drift as the business grows. **Recommendations:** - Apply analytics or on-prem AI to complaint and nonconformance text to surface emerging trends earlier than manual review. - Use your DHR data to shorten batch release review by flagging only exception units for human review. - Formalize configuration governance so growth into new sites or product lines does not fragment your validated design. - Benchmark your traceability response time annually and treat regression as a defect, not an inconvenience. - Extend the same discipline to supplier data so incoming quality trends feed sourcing decisions. ## Content **Intro:** This free assessment scores how well your current or shortlisted ERP supports medical device manufacturing, and it is built for quality directors, regulatory affairs leads, and IT managers at Class II and Class III device makers. Ten questions cover device history record generation, bidirectional lot traceability, 21 CFR Part 11 electronic records, change control, CAPA integration, supplier controls, computer system validation, UDI management, complaint linkage, and shelf-life control. You get a percentage score, a fit band, and specific remediation priorities. Use it before an ERP selection, ahead of a notified body audit, or when building the case for replacing a system that cannot carry regulatory weight. **Sections:** #### How this assessment is scored **Body:** Each of the ten questions offers four graded answers worth zero to three points, for a maximum of thirty. Your raw score is converted to a percentage and mapped to one of four fit bands. The questions are deliberately weighted toward evidence generation rather than feature checklists, because regulators do not audit your feature list - they audit whether the record exists, whether it is attributable, and whether you can produce it on demand. Answer based on how the system behaves today in production, not how it was configured on paper or demonstrated by a vendor. If two answers seem equally true, choose the lower one; optimistic self-scoring hides exactly the gaps this tool exists to find. #### The requirements behind the questions **Body:** The questions map to the obligations that most commonly generate FDA Form 483 observations and ISO 13485 nonconformities in device manufacturing. We weight traceability, records, and supplier controls heavily because those three areas account for a disproportionate share of findings across the industry, and because each one depends on the ERP rather than on a standalone quality system. An inspector asking for a device history record is not asking whether you own software that could produce one; they are asking you to produce it now, for a specific serial number, with every material lot, operator, and acceptance activity attached. The four obligations below are the ones this assessment tests most directly. **Bullets:** - 21 CFR Part 820 subpart M requires a device history record proving each batch was made per the device master record. - 21 CFR Part 11 requires attributable, immutable audit trails and meaning-bearing electronic signatures for regulated records. - ISO 13485 clause 7.4 requires documented supplier evaluation and enforcement of purchasing controls. - FDA UDI rules require accurate device identifiers maintained and submitted to GUDID with each label change. #### Reading your score and setting priorities **Body:** Below forty percent, the ERP is not carrying compliance load and your quality system depends on people remembering to bridge the gap. Between forty and sixty, core transactions are sound but manual handoffs between ERP and quality systems create the risk. Above sixty, the design is right and the remaining work is discipline: validation cadence, configuration governance, and exception monitoring. Whatever your band, look at individual zero and one answers before the composite score. A single zero on lot genealogy matters more than three ones spread across convenience features, because genealogy is the foundation that DHR, complaint investigation, and recall response all sit on top of. #### How Netray helps you close the gaps **Body:** Netray implements and remediates Infor SyteLine and CloudSuite Industrial for regulated discrete manufacturers, including medical device makers who need the compliance evidence to come out of the system rather than out of a binder. We build lot and serial genealogy, electronic DHR assembly, enforced supplier controls, and risk-based validation packages that survive vendor release cycles. Where confidentiality or data residency rules make cloud analytics impractical, we deploy on-prem AI inside your firewall to accelerate complaint triage and nonconformance trending. Engagements typically start with a gap assessment against your actual configuration, followed by a prioritized remediation roadmap tied to audit exposure. **Cta:** Get a detailed gap analysis of your ERP against medical device regulatory requirements from Netray's regulated manufacturing specialists. **Faq:** #### Does a validated ERP mean my quality system is compliant? **Answer:** No. Validation proves the software performs as intended for its specified use; it says nothing about whether your procedures, records, and controls satisfy Part 820 or ISO 13485. Plenty of validated systems still produce incomplete device history records because the configuration never captured the required evidence. Treat validation as a prerequisite for relying on the system, then separately verify that the records it produces are complete, attributable, and retrievable. #### Can a general discrete manufacturing ERP work for medical devices? **Answer:** Often yes, provided lot and serial genealogy, audit trails, electronic signatures, and status control are native rather than bolted on. Platforms like Infor SyteLine are used successfully by device manufacturers when configured deliberately for traceability and record retention. The risk is not the platform category but the implementation: teams that configure for speed rather than evidence end up with a fast system that cannot survive an inspection. #### How often should we revalidate after cloud ERP updates? **Answer:** Use a risk-based approach rather than a fixed calendar. Assess each vendor release for impact on the functions that produce regulated records, then execute regression tests scoped to those functions. Manufacturers with automated regression scripts typically validate a quarterly release in days rather than weeks. The unsustainable pattern is full manual revalidation every cycle, which either consumes the quality team or quietly stops happening. ## Search terms medical device ERP requirements, ISO 13485 ERP software, 21 CFR Part 820 ERP, FDA compliant ERP for medical devices, device history record ERP, UDI GUDID ERP software, medical device ERP selection checklist --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json