One platform to run Product Compliance
Connect product, supplier and regulatory data once and use it across compliance management, registry submissions and upcoming Digital Product Passports. One shared foundation helps you meet today’s requirements and adapt when products, markets or regulations change.
Product compliance that scales with every product, supplier and market.
The osapies HUB for Product Compliance – one connected data foundation to automate repetitive work, manage the full DPP lifecycle and scale confidently as your portfolio, partner network and regulatory scope grow.
What challenges are you dealing with?
osapiens HUB for General Product Compliance
Integrate each product once and connect it to its components, suppliers, markets and applicable regulations. Existing data flows in from ERP and PLM systems, while missing evidence can be requested directly from suppliers. Automated checks reveal compliance gaps, trigger the right workflows and keep every product record complete, current and ready for audits or market access decisions.
osapiens HUB for ftrace
Track every lot from harvest, catch or farm through processing and distribution to the consumer scan. Partners capture each step as a standardized traceability event, creating one continuous chain of custody across the supply network. When an audit, investigation or recall occurs, you can identify affected lots and trace their path forwards or backwards without piecing information together manually.
osapiens HUB for Medical Devices
Import medical device data from ERP, PLM, PIM, REST interfaces or structured Excel files and validate it against registry-specific requirements. Manage Basic UDI-DIs, packaging levels and product relationships in one versioned record with a complete change history. From there, submit consistent data to EUDAMED, Swissdamed, AusUDID or FDA GUDID without maintaining separate processes for every registry.
osapiens HUB for Tobacco Track & Trace
Order unit-level and aggregated Unique Identifiers from national ID issuers and make them available directly to the production line. Apply and verify codes through Line Controllers, Mobile or Manual Stations, then build the hierarchy from individual packs to cases and pallets. Every required event is reported to the primary and secondary repositories, creating a complete traceability process for the EU Tobacco Products Directive.
osapiens HUB for Digital Product Passport
Connect information from products, components, suppliers and existing business systems in one structured data foundation. Validate which information is required, close missing-data gaps and generate a product-specific Digital Product Passport from the resulting record. As materials, suppliers or regulatory requirements change, the passport can be updated without rebuilding the underlying data process from scratch.
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What mattered most to us was osapiens' deep expertise in Tobacco Track & Trace and their ongoing support beyond the software itself.
Tobias BjörneskogCo-Founder Yoik Group AB (Helwit)
Frequently asked questions
Product compliance means ensuring that a product meets all legal, regulatory and market-specific requirements that apply to it. This can include rules for product safety, materials, restricted substances, documentation, traceability, labelling and regulatory submissions. Effective product compliance protects market access and helps you provide the evidence regulators, customers and business partners require.
The suite brings together General Product Compliance, Food Traceability, Medical Devices, Tobacco Traceability and Digital Product Passports. Depending on the use case, it supports everything from identifying applicable requirements and collecting supplier evidence to tracing products, validating regulatory data, submitting records to authorities and making product information accessible through a DPP.
General Product Compliance covers requirements including PPWR, REACH, RoHS, PFAS, POPs, the EU Battery Regulation, GPSR and SCIP. The suite also supports UDI submissions for medical devices, EU TPD track and trace for tobacco products, and GS1- and EPCIS-based food traceability. Additional company-specific or regulatory standards can be added to the same product data foundation.
Product, material, component and supplier data is brought together in one connected structure. Information collected for one requirement can then be reused across other regulations and processes instead of being requested, checked and maintained again. This reduces duplicate work and prevents every new requirement from creating another isolated data process.
Yes. The suite is modular, so you can begin with a specific regulation, product group or process and add further requirements over time. Once the underlying product and supplier data is connected, it can be reused as you activate additional regulations, traceability processes, registry submissions or Digital Product Passports.
You can send structured data requests and questionnaires directly to suppliers through the osapiens Portal. Suppliers provide documents, declarations and product information in a guided process, while automated workflows track responses, identify missing evidence and trigger follow-ups. Submitted information can be reused across multiple requirements instead of repeatedly requesting the same data.
Yes. Product and transaction data can be integrated from systems such as ERP, PLM and PIM through standard interfaces and ready-made connectors, including SAP integrations. The suite also connects to relevant external registries and regulatory platforms, allowing data to move from your internal systems into validation, compliance and submission workflows without manual re-entry.
Compliance information remains connected to its source, supporting documents, responsible owners and revision history. Automated validations highlight incomplete or inconsistent records before they become an audit or submission issue. This gives internal teams, auditors and regulatory authorities a traceable record of what was submitted, which evidence supports it and how the information changed over time.
A single-regulation tool usually solves one requirement but creates a separate data structure and workflow. The osapiens Product Compliance Suite connects multiple regulations and industry-specific processes to the same product data foundation. You collect and maintain information once, then reuse it across existing obligations and future requirements such as Digital Product Passports.
Built-in rule sets, workflows and legally validated templates help translate regulatory requirements into concrete data requests, checks and documentation processes. When requirements evolve, the relevant rules and workflows can be updated centrally rather than rebuilding the complete compliance process for every product or business unit.
