Anonymous CDMO

As the client prepared for a substantial scale-up of its production capacity, it faced the critical need to streamline and standardize processes to ensure consistent and compliant operations across both new and existing facilities. Their existing setup relied on many locally managed systems, siloed knowledge, and manual workflows - including Excel sheets to manage vital production data. As expansion progressed, this fragmented ecosystem exposed the client to increasing operational and compliance risks, including:

• Process variability across sites

• Increased likelihood of configuration errors

• Limited transparency and cross-site collaboration

• Knowledge silos slowing down operations

• Lack of end-to-end visibility of configurations and dependencies across departments

• Onboarding bottlenecks due to inaccessible or localized expertise

• Manual data management and lack of unified control

• Heightened compliance risk under strict GxP regulatory requirements

To enable the expansion and safeguard regulatory compliance, the client required a scalable, validated platform capable of harmonizing global production processes, mitigating operational risks, and empowering teams to operate with greater autonomy.

Our approach

We kicked off the engagement with a focused 10-week discovery phase, led by a multidisciplinary core team consisting of a solution architect, product manager, and designer. During this phase, we conducted an in-depth analysis of the client’s desired business outcomes, existing processes, IT landscape, and regulatory requirements. This process enabled us to identify key challenges and define the foundation for a long-term, tailored roadmap.

Given the project’s scale, complexity, and regulatory demands, the resulting roadmap was designed as a high-level strategic framework - ensuring conceptual coherence, defining a meaningful sequence for the development work, and identifying the critical workshops and verification activities required throughout the project lifecycle. This approach ensured that essential functionality would be thoroughly explored, designed, and verified at the appropriate stages throughout the project.

Following the discovery, we entered a long-term development partnership, scaling up to a cross-functional team of up to 21 specialists at its peak, including designers, developers, product managers, solution architects, and QA engineers. The project was structured along two parallel tracks:

• Continuous system development

• Continuous discovery, refinement, and validation of requirements

A defining success factor was the early and embedded role of Quality Assurance (QA) - not as a late-stage checkpoint, but as a core design principle. By actively involving QA in the definition of requirements, we ensured that quality, compliance, and usability were not afterthoughts but integral to the platform's DNA. 

To further strengthen our process, we collaborated with the client to develop a tailored Configuration Management Procedure. This procedure formalized key practices, including systematic code reviews, adherence to coding guidelines, comprehensive acceptance criteria and definition-of-done checklists, and the use of verified designs. By building quality into the development cycle itself, rather than relying solely on testing, we aligned with the well-established principle that sustainable quality cannot be tested in, but must be designed in from day one.

This proactive approach enabled faster validation, reduced regulatory risk, and delivered a solution ready for real-world production from day one. 

The documentation

Operating within a GxP-regulated environment imposed strict requirements for traceability, documentation, and testing. To meet these expectations, every release into the client’s ecosystem was accompanied by a comprehensive documentation package, ensuring end-to-end traceability - from high-level User Requirements (URS) through Functional Specifications (FS) and Detailed Design Specifications (DDS), all systematically mapped to test cases via a dedicated Requirement Traceability Matrix (RTM). This provided full coverage control and transparency across the entire validation lifecycle.

The test documentation covered approximately 6,500 individual test cases, each executed systematically and fully traceable - including tester identity, execution details, and test results. 

In addition to development and test documentation, we delivered critical system documents, including the Configuration Specification (CS) and comprehensive System Management documentation, further strengthening the platform’s governance foundation.

Together, these practices ensured that every feature, change, and release could be readily demonstrated to both regulatory authorities and the client’s internal quality organization - securing consistent quality and sustainable compliance.