Agentic AI, computer vision, generative AI
Web, mobile, and custom software
Engineering, warehousing, analytics
Farm, livestock, and crop software
Traceability and food supply chain
EHR, telehealth, and interoperability
ERP implementation and support
Dynamics 365 and Business Central
CRM consulting and integration
B2B ecommerce, ERP integrations and migrations
Folio3 Dynamics implements Dynamics 365 for FDA-regulated manufacturers. This includes full lot genealogy from raw material through finished dispatch, electronic batch records configured to 21 CFR Part 11 requirements, and native recall traceability.
These are three problems Folio3 sees repeatedly in FDA-regulated ERP implementations. Each is fixable before an audit.
Quality teams often take days to close a batch record because the source data lives across paper logs, environmental printouts, and multiple systems. Product stays in quarantine longer than it should.
Tracing a raw material lot forward through every batch and customer shipment can take days when the data isn't structured for it. Mock recalls that should take hours take a week.
Manual data flow between the ERP and the QMS, weak audit trails on inventory adjustments, and gaps in electronic-signature controls are common on FDA inspections. The CAPAs stay open because the underlying system hasn't changed.
For smaller nutraceutical, cosmetic, or food operations with simpler regulatory profiles. Item tracking and lot genealogy are native. Part 11 controls come from validated add-ons.
Company size
SMB to mid-market
Regulatory profile
Standard, non-injectable
Deployment
Cloud-native
Batch records
Native item and lot tracking
Part 11 controls
Via validated add-on
For pharmaceutical, medical device, and complex food or nutraceutical operations. Full process manufacturing depth, native quality management, and Part 11 controls built into the platform.
Company size
Mid-market to enterprise
Regulatory profile
High, multi-modality
Deployment
Global, multi-currency
Batch records
Full eBR with genealogy
Part 11 controls
Native, configured in scope
Each batch generates a complete electronic record: master formula, amounts issued, operator sign-offs, deviations, and final release approval. Any lot can be pulled up on demand.
Formula management with version control and effective dating. Batch orders generate a full electronic batch record as production runs. Part 11 electronic-signature workflows apply to every release-related action. Deviations are captured inside the batch record they came from.
Given a raw-material lot number, the system returns every finished-good lot it touched and every customer shipment affected. Trace queries run in hours. Quarantine actions are queued automatically.
Full lot genealogy from raw material receipt through finished-goods dispatch, with catch-weight and potency tracking. Trace queries run forward from a supplier lot and backward from a customer complaint. Quarantine actions and hold codes trigger automatically when defined thresholds are hit.
Deviations recorded during production link to the batch, operator, equipment, and raw materials. The resulting CAPA links back to those records, and the effectiveness check pulls its evidence from live ERP data.
Non-conformance capture, deviation workflows, and CAPA lifecycle management inside the platform. Document control ties to master records. For deeper QMS integration, Folio3 connects Dynamics 365 to validated third-party systems like MasterControl or Veeva through the BURQ iPaaS platform.
Electronic-signature workflows on every release-relevant action. Signed audit trails, unique-user identification, signature meanings, and manifest linking are set up during implementation.
IQ, OQ, and PQ activities scoped alongside the technical build. Folio3 follows GAMP 5 categorization and delivers the validation documentation package for your quality team.
DSCSA serialization for pharmaceutical operations, EU FMD support where applicable, and unit-level traceability for medical devices. Configured against your labeling infrastructure and 3PL data exchange requirements.
FEFO and FIFO picking, quarantine location control, temperature and humidity monitoring integration, and expiry-date-driven inventory workflows. Cold-chain sensors and IoT devices connect through Microsoft's standard IoT infrastructure.
Copilot for Supply Chain runs inside the same audit trail as the rest of the platform. Governance controls keep AI-generated recommendations reviewable and reversible. Regulated actions still require the process electronic signature.
Folio3 runs a scoped audit of where the configuration stopped meeting validation requirements. The team keeps the parts that still work and rebuilds the parts that don't. Full rip-and-replace is often avoidable.
Book a demo with a Folio3 Dynamics manufacturing lead. Walk through Dynamics 365 configured for your regulatory profile. Bring your questions.
The client was using Magento for eCommerce and D365 FSM for backend operations and faced challenges with manual data syncing between the two systems, leading to errors and inefficiencies. To support business growth, they sought to automate data synchronization and streamline operations.
Burq iPaaS streamlined the integration between Magento and D365, syncing product details, inventory, prices, orders, and customer accounts. It also ensured seamless product mapping and streamlined data flow across both systems.
It significantly impacted TricorBraun process efficiency by over 95%. They were able to achieve near real-time data synchronization between their systems with a 100% data accuracy rate.
Yes, for the parts that touch regulated processes. Under GAMP 5, the ERP components carrying GxP data are treated as Category 4 or 5 software, which means IQ, OQ, and PQ activities are scoped alongside the technical build. Folio3 delivers the validation documentation as part of a regulated implementation.
It's driven by regulatory profile and process depth more than by revenue. Business Central works for simpler food, nutraceutical, or cosmetic operations where Part 11 controls come from a validated add-on. Finance and Operations fits pharmaceutical, medical device, and complex process operations where eBR, potency tracking, and native Part 11 controls need to be configured into the platform itself.
Yes. Most regulated manufacturers keep their validated QMS in place and connect it to Dynamics 365 through the BURQ iPaaS platform. Deviations, CAPAs, and change controls flow between the systems, and the audit trail spans both. Where the customer wants to consolidate, Dynamics 365 handles CAPA and non-conformance workflows natively.
Dynamics 365 supports unit-level serialization, aggregation and disaggregation events, and the transaction data exchange DSCSA requires. Folio3 configures it against your labeling infrastructure, 3PL data exchange, and EPCIS reporting requirements. EU FMD support is available for operations shipping into European markets.
It depends on the tier and the regulatory profile. Business Central with a validated Part 11 add-on typically runs 4 to 6 months for straightforward operations. Finance and Operations standard implementations run 9 to 15 months with validation activities in scope. Multi-site or specialty modality rollouts run 18 months to 3 years. Discovery produces a validated timeline against your specific profile.
Often the fastest way to inspection-readiness is a scoped migration to a properly validated Dynamics 365 configuration. Folio3 runs a pre-migration assessment that identifies which parts of your current configuration are salvageable, which validation artifacts you already have, and the shortest path to a defensible audit trail.
