A multinational biotechnology company that recently completed a merger with another large biotechnology company identified a gap in out-of-trend (OOT) analysis in its product stability program. The labs decided to develop a bespoke stability trending tool to close the potential compliance gap and standardize stability analysis across the enterprise. They wanted to interface the new tool with their existing ChemLMS and LabWare LIMS™ applications, so the tool and its interfaces required full validation.
The client lacked internal resources to complete the development and validation tasks and engaged CSols Inc. to plan and manage, document, and execute the computer systems validation (CSV).
The client aimed to develop, interface, and validate a tool to ensure compliant OOT analysis for their stability program. As part of this project, the client wanted to remove manual calculations from the analysis process via automation. The project was part of a global effort to standardize stability OOT analysis methodology across the organization.
- Lack of software testing resources: the client had limited internal resources to create detailed test cases and scripts that could be run by the inexperienced testers
- Offshore software testing resources: communications and coordination required vigilant and rigorous project management
- Aggressive timeline: several sites needed the new software rolled out and validated right away to satisfy regulatory observations
CSols’s Role in the Solution
CSols provided validation project management and planning services, validation test script development, and project management services, including managing and communicating with offshore testing resources. This effort included the following tasks and deliverables:
- Developed and executed a plan to eliminate redundant development and validation activities
- Developed validation plans for the new stability testing analysis tool, the LabWare LIMS integration, and the ChemLMS integration
- Performed functional risk assessment
- Developed test plans for the new tool and the interfaces
- Developed compliant test cases for the new tool and the interfaces
- Managed and communicated with offshore testing resources
- Increased laboratory efficiency via automated OOT analysis
- Increased efficiency via enterprise-wide standardization of OOT analysis
- Improved regulatory compliance via the new stability trend analysis tool
- Improved OOT analysis via bespoke stability analysis tool
- Reduced validation costs via test case development and effective management of off-shore testing resources
- Increased regulatory compliance and audit readiness
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