# AI for Dynamics 365 Business Central in Medical Device Manufacturing > Source: https://netray.co/erp-ai/dynamics-365-business-central-medical-devices-ai > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: AI for ERP ## Short answer AI for Business Central in medical device manufacturing helps quality and operations teams retrieve lot and serial genealogy, assemble device history record evidence and prepare audit packages from ERP data and controlled documents, using a private model with every answer tied to its source records. It supports QMSR and ISO 13485 workflows but does not replace a validated QMS or regulatory judgment. ## Kind industry ## Erp Family microsoft ## Erp Products - Dynamics 365 Business Central ## Industries - Medical Devices - Life Sciences - Contract Manufacturing ## Region Global ## Persona Quality Manager ## Eyebrow Business Central + medtech AI ## Intro Small and mid-size device makers often run Business Central for inventory, production, purchasing and finance while the quality system lives elsewhere: an eQMS such as a dedicated document and CAPA tool, or controlled documents on a share. The ERP holds lots, serial numbers, production orders and supplier data; the QMS holds procedures, complaints, nonconformances and approvals. The two meet at audit time. That seam is where time disappears. A device history record request, a complaint investigation or a supplier audit needs records from both systems, and the person assembling them has to know which Business Central entries correspond to which QMS record. Native Business Central has no device history record or design history file concept; it provides tracking, change logging and posted ledgers that support one if configured consistently. Regulation is also shifting. FDA's Quality Management System Regulation, which amends 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, took effect in February 2026, and EU MDR keeps its own demands for traceability and post-market surveillance. Computer systems that touch quality records must be validated for intended use, which makes any AI layer something to scope carefully rather than sprinkle in. This page lays out a conservative approach: read-only AI over ERP and controlled documents, hosted privately, producing drafts and retrieval for qualified staff. It describes what is helpful, the objects involved, and what remains your quality system's job. ## Pain Points ### Genealogy spans systems **Detail:** Serial and lot history is in Business Central, while the nonconformance or complaint that triggered the question is in the QMS. Linking them is manual, which slows complaint and field-action investigations. ### Device history record assembly is tedious **Detail:** Collecting production order data, component lots, test results, labeling and release approvals for each unit or batch takes hours when pieces live in different places. ### Supplier control evidence is scattered **Detail:** Approved supplier status, certificates, audit reports and incoming inspection results are spread across vendor records, attachments and files, making periodic reviews slow. ### Change control touches many records **Detail:** An engineering change affects BOM versions, routing versions, open orders and stock of old revisions. Verifying the effect in the ERP is a separate exercise from the change record. ### Validation burden discourages tooling **Detail:** Every new tool touching quality data needs documented intended use and risk-based assurance, so teams avoid helpful tools or adopt them informally, which is worse. ## Use Cases ### Lot and serial genealogy retrieval **Description:** Given a finished serial or lot, the assistant lists component lots, supplier receipts, production order and test or inspection entries, with each source linked, as a draft for the quality engineer to verify. **Erp Objects:** Item Ledger Entry, Serial No. Information, Lot No. Information, Item Application Entry, Production Order **Outcome:** Faster first-pass genealogy for complaint and field-action investigations; the engineer reviews and signs. ### DHR evidence compilation **Description:** For a batch, the agent assembles production order data, consumption lots, operator and work center entries, labeling references and release dates into a checklist against your DHR template and flags missing items. **Erp Objects:** Production Order, Prod. Order Component, Capacity Ledger Entry, Item Tracking Line, Document Attachment **Outcome:** Shorter review cycles and earlier detection of missing entries before release. ### Approved supplier review **Description:** Quality asks which suppliers of critical components lack a current audit, certificate or approved status and receives a sourced list. **Erp Objects:** Vendor, Item Vendor, Purchase Receipt Line, Document Attachment, Vendor custom fields **Outcome:** Periodic supplier reviews prepared from data, not memory. ### Change impact check **Description:** Before an engineering change is implemented, the assistant lists affected BOM and routing versions, open production orders, stock of superseded revisions and purchase lines in flight. **Erp Objects:** Production BOM Version, Routing Version, Prod. Order Line, Item Ledger Entry, Purchase Line **Outcome:** Fewer mixed-revision builds and a documented impact summary attached to the change record. ### Audit preparation Q&A **Description:** Staff ask audit-style questions such as how a given purchase is controlled; the assistant retrieves the relevant procedure sections and sample ERP records with citations. **Erp Objects:** Controlled documents index, Change Log Entry, Purchase Header, Item Tracking Line **Outcome:** Auditor questions answered with references faster, with staff verifying the answer. ### Expiry and sterility date monitoring **Description:** A daily read of lots with expiration dates by location and open demand, flagging stock that cannot ship within remaining shelf life requirements. **Erp Objects:** Lot No. Information, Item Ledger Entry, Bin Content, Sales Line **Outcome:** Less expired stock discovered late. ### UDI and labeling data checks **Description:** The agent compares item GTIN and UDI attributes held in item or custom fields against labeling records and flags inconsistencies for review. **Erp Objects:** Item, Item Reference, custom UDI fields, Item Ledger Entry **Outcome:** Inconsistencies found before shipment rather than during an audit. ## Architecture **Overview:** A private, read-only layer retrieves from Business Central and from your controlled-document store, produces cited drafts and never writes to quality records. The design is built so it can be described in an intended-use statement and assured proportionately to risk. **Layers:** #### ERP read interface **Detail:** Scoped API pages over ledger, lot, serial, production and vendor data, with Change Log Entry exposed where audit trail review matters. #### Controlled document index **Detail:** Procedures, work instructions and specifications indexed with document ID, revision and status, so only effective revisions are cited. #### Citation and traceability **Detail:** Each statement carries a pointer to the ledger entry or document revision it came from; unsupported answers are declined. #### Model hosting **Detail:** Open-weight models hosted privately, with version pinning so behavior is stable between validations. #### Assurance and logging **Detail:** Intended-use statement, risk assessment, test set and prompt logs retained to support a risk-based assurance approach. ## Deployment Options ### Dedicated private environment **Fit:** Device makers with strict IP and design confidentiality **Detail:** Model and index run in a locked-down subscription or on-site server; Business Central is accessed through scoped service credentials. ### On-prem with Business Central On-Premises **Fit:** Contract manufacturers with customer-imposed data limits **Detail:** All components inside the plant network with no external model calls; updates are scheduled and documented. ### Staged pilot on a sandbox copy **Fit:** Teams that must complete risk assessment before touching production **Detail:** Begin on a sandbox environment with masked data, finalize intended use and tests, then switch the read connection to production. ## Compliance ### The assistant supports retrieval and compilation of records; procedures for document and record control remain the manufacturer's responsibility. **Framework:** FDA QMSR (21 CFR Part 820) and ISO 13485:2016 ### The AI does not sign or approve; Business Central's change log and your QMS handle audit trails, and AI outputs are treated as drafts. **Framework:** 21 CFR Part 11 electronic records and signatures ### Risk-based assurance for the tool's intended use, with documented test cases; version pinning of models. **Framework:** FDA Computer Software Assurance guidance ### Traceability and UDI consistency checks assist post-market surveillance data gathering; regulatory strategy stays with your team. **Framework:** EU MDR and UDI requirements ### Private hosting keeps designs, suppliers and process data inside your boundary. **Framework:** Design confidentiality ## Integration Notes - Expose Serial No. Information and Lot No. Information along with Item Application Entry; genealogy from lot numbers alone is incomplete. - Turn on and expose the Change Log for tables where audit trail matters, and set a retention policy since it grows quickly. - Document the intended use of the tool: read-only retrieval and drafting, no record creation or approval. - Pin model version and prompt templates; re-run the test set before any change, and keep results as assurance evidence. - Integrate with the eQMS through its API or export only for read access, matching records by item, lot or NCR number. - Plan for Business Central release waves: test custom API pages in sandbox preview before each wave. ## Product Fit ### ERPray **Why:** Cited genealogy, supplier and expiry questions over Business Central with permissions respected. ### DataRay **Why:** Searching controlled documents and audit files on local shares together with ERP records. ### Custom build **Why:** DHR compilation workflows and integrations with your eQMS under a documented intended-use statement. ## Engagement ### Scope and intended use **Duration:** 1 to 2 weeks **Deliverables:** - Intended-use statement and risk assessment draft - Records and systems map (ERP and QMS) - Priority retrieval scenarios ### Sandbox build **Duration:** 3 to 4 weeks **Deliverables:** - Read-only endpoints and document index - Test cases with expected answers - Citation behavior review ### Assurance and pilot **Duration:** 3 to 4 weeks **Deliverables:** - Executed test evidence - Pilot with quality engineers - Access and logging review ### Controlled release **Duration:** 2 to 3 weeks **Deliverables:** - Production read connection - Change procedure for model and templates - Training and runbook ## Buyer Questions - How does the vendor support our computer software assurance approach? - Is the tool strictly read-only, and how is that enforced? - Does every statement include a citation to a record or controlled document revision? - How is the model version controlled and re-tested after changes? - Where do designs, supplier data and complaint details get processed? - How does it handle Business Central release waves? - What happens when the answer is not supported by records? ## Faq ### Can an AI tool be used in a regulated medical device environment? **Answer:** Yes, with discipline. Define the intended use, assess the risk, test against known cases, control versions and keep humans accountable for decisions. A read-only retrieval and drafting tool carries less risk than one that creates or approves records. Your quality team and regulatory advisor decide what assurance is sufficient. ### Does Business Central include a device history record? **Answer:** Not as a named feature. It provides production orders, tracking, ledgers and a change log that can support a DHR if processes and configuration are consistent. Many manufacturers combine it with an eQMS or controlled documents. The AI helps assemble evidence across them; it does not create the record structure. ### What changed with QMSR? **Answer:** FDA's Quality Management System Regulation amends 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, effective February 2026. For ERP users, the practical effect is alignment with ISO 13485 terms and expectations. Confirm specifics with your regulatory advisor; this page does not provide regulatory advice. ### Will it write CAPAs or approve changes? **Answer:** No. It can retrieve related records and draft summaries that a qualified person reviews. Creating or approving CAPAs, nonconformances and changes should remain in your QMS under your procedures and electronic signature controls. Keeping the AI out of the approval path simplifies assurance. ### How do you prevent made-up answers? **Answer:** By requiring citations to specific ledger entries or document revisions and declining to answer when none support a statement. We also maintain a test set of known questions run after any change. No approach eliminates errors, so staff verify before relying on an answer in a record. ### Can we run it fully offline? **Answer:** Yes. With open-weight models on local GPUs and Business Central On-Premises, the system can run in a network with no internet access. For SaaS tenants, only the scoped API calls reach the tenant, and model processing stays on your infrastructure. ### How long does a validated pilot take? **Answer:** Typically eight to twelve weeks, driven more by intended-use documentation, test design and review cycles than by technical build. Teams with an existing assurance procedure move faster. We recommend starting in a sandbox with masked data while paperwork is completed. ## Search terms business central medical device manufacturing, business central iso 13485, business central serial lot traceability medical device, ai for medical device manufacturers erp, qmsr 21 cfr 820 erp, business central device history record, dynamics 365 business central life sciences, business central udi traceability, computer software assurance ai erp, private llm medical device quality, business central change log audit trail --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json