Highlights
- GxP-Ready Data Mappings Across Partner Systems: our team defined, documented, and validated the rules that map and transform partner data into the platform’s standard format for regulated pharma and biotech environments.
- End-to-End Data Flow Visibility: every data flow handled by the integration layer is now visible in the platform’s UI.
- Steady Delivery Amid Changing Requirements: we kept documentation and mappings in sync as requirements evolved, so the specification and implementation stayed aligned.
- One Specification Across All Stakeholders: we worked with the client’s developers and QA engineers to reconcile conflicting data requirements into one agreed behavior for every data flow.
Client
The client is a UK-based B2B SaaS company serving the pharmaceutical and life sciences industry. Its platform gives drug makers live visibility into the work they outsource to contract manufacturers (CMOs), contract packagers, and third-party logistics (3PL) providers.
These external operations usually fall outside pharma companies’ ERP and planning systems, so teams rely on emails, spreadsheets, and phone calls. The client replaces them with one shared, compliant view used by pharma companies and their service providers worldwide. The company is certified to ISO 27001:2022 and ISO 9001:2015 and complies with GDPR.
Product
The product is a cloud platform for managing outsourced logistics in regulated pharma supply chains. It pulls live data from external partners into one place, so supply problems can be spotted and fixed before they cause a disruption. For one pharma customer, the platform saved 42% per partner integration and cut new-market entry to under 3 months.
Its main users are external manufacturing and supply teams at mid-size and large pharma companies, biotechs that own no factories, and the service providers that work for them. Supply planning, procurement, quality assurance, and logistics teams use it too. For service providers, the platform also works as a sales channel: each connected provider brings its pharma clients onto the network.
The key product components include:
- Data Integration Layer: It collects data from manufacturers, packagers, 3PLs, and suppliers into one data layer that every other module is built on. Partners send data through existing channels such as AS2, HTTPS, SFTP, FTPS, email, or file upload, in formats ranging from CSV, XML, and JSON to EDI, iDoc, and Excel. Automatic format classification cuts manual mapping effort during partner onboarding by 80%.
- Compliance and Collaboration Layer: Tamper-evident audit trails meet 21 CFR Part 11 and GAMP 5, secure document sharing, approval workflows, and free guest access for partners, with role-based dashboards for each team. The platform also supports EU GMP Annex 11, ALCOA+ data integrity principles, EU Good Distribution Practice (GDP) and the US Drug Supply Chain Security Act (DSCSA), and is validated to GAMP 5 Category 4, with IQ/OQ documentation updated on each release.
- Inventory, Order, and Shipment Tracking: Live stock levels across partner sites, purchase orders and deliveries, including temperature-controlled shipments.
- Forecast Reconciliation: Checks demand forecasts against what partners have committed to supply and supports joint planning with them.
- Supplier Performance and Risk Monitoring: Scores partners on delivery, quality, and responsiveness, and sends alerts about delays, deviations, and quality events.
Goals and objectives
- Establish Precise Cross-System Data Mapping: define how each data entity moves from partner systems, whatever their format or channel, into the platform’s data layer.
- Guarantee Accurate and Consistent Data Transformation: build and validate transformation logic that converts partner data into the platform’s standard format completely and consistently.
- Ensure Traceability for GxP Compliance: keep every transformation traceable to its source, in line with EU GMP Annex 11, FDA 21 CFR Part 11, and ALCOA+.
- Unify Stakeholder Requirements: reconcile the different data mappings each stakeholder group expected into one agreed specification.
Project challenge
- Complex and Heterogeneous Data Sources: partners sent data through different channels, from AS2 and SFTP to email, and in formats ranging from CSV and XML to EDI and JSON, each with its own structure, so every mapping demanded careful analysis.
- Accurate and Consistent Transformation at Every Step: each record had to be transformed identically every time, with no loss or distortion between source and destination, because stock, order, shipment, and supplier views all rely on the same data layer.
- Conflicting Stakeholder Requirements: separate teams and stakeholders brought their own data mappings and transformation rules, which we had to reconcile into one specification before development could move forward.
- Requirements That Evolved Mid-Project: requirements shifted during development, so the data mappings had to stay aligned with a moving specification while the solution was being built.
- Strict Regulatory Requirements: because the platform operates under GxP rules such as EU GMP Annex 11, FDA 21 CFR Part 11, and ALCOA+, every transformation had to stay traceable to its original source file and fully auditable.
Solution
Our team of 12 specialists began by working directly with the client’s developers and QA engineers to clarify requirements and agree on the expected behavior of each data flow. We analyzed and documented those requirements, so every team worked from the same specification.
Our engineers then built the data mapping, conversion, and transformation logic with ETL tools, converting partner data into the platform’s standard format, and validated each mapping and transformation rule against the agreed requirements.
We also implemented internal data-flow functionality in the platform so every data flow appears in the user interface. As requirements changed, we updated the documentation and mappings together, keeping all stakeholders aligned through to delivery.
Tech Stack
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AWS Fargate -
Amazon S3
Our results
We delivered a reliable, validated data mapping and transformation layer that gives the client’s team a solid foundation for supporting their data flows, with every flow visible in the platform interface.
- Validated, Audit-Ready Data Mappings: every mapping and transformation rule was documented and verified against the agreed requirements, supporting the platform’s compliance.
- One Consistent Data Foundation: partner data arrives in one standard format, giving every module, from stock visibility to supplier performance, the same reliable base.
- Required Functionality Delivered: with validated mappings in place, the client’s team delivered the platform functionality they needed.
- Requirement Changes Absorbed Without Disruption: shifting requirements and clarifications were managed throughout development, keeping delivery on track.
The collaboration has ended, leaving the client’s team equipped to support and extend the platform’s data flows independently.atures, such as trending items and recommendations in the search results.