Providing Computer Software Assurance (CSA) Guidance for LIMS for a Cell and Gene Therapy CDMO
Clarkston Consulting recently worked with a cell and gene therapy CDMO on providing CSA guidance for LIMS. Read a synopsis of the project below or download the full case study.
Download the CSA guidance for LIMS Case Study Here
The client is a Contract Development and Manufacturing Organization (CDMO) that specializes in cell and gene therapy, with a focus on lentiviral and cell therapy research, development, and bioprocessing. The company chose the development and delivery of new gene therapies for viral diseases, produced by the engineering of viruses based on lentiviruses and adeno-associated viruses (AAV), as its main target.
The client has more than 25 years of experience in viral vectors and has recognized leading solutions for the commercially approved lentiviral-based gene delivery system. The company established AAV manufacturing production and has been operating for Good Manufacturing Practices (GMP) production, recently expanding laboratories and its GMP footprint on-site. With expanding GMP facilities, growing data, and the intention to deliver high-level products and boost laboratory efficiency, the company decided to implement a Laboratory Information Management System (LIMS) into the manufacturing process.
Clarkston Consulting was asked to partner with the company on their LabVantage LIMS project and ensure the implemented solution leveraged a risk-based approach to validation and Computer Software Assurance (CSA) guidance. The Clarkston team supported the development of the documentation and testing of the LabVantage LIMS application to ensure it met all its intended business requirements.
By leveraging a risk-based approach and developing the risk assessment documents for the solution, Clarkston assisted the client in setting validation process guidelines with the continuous improvement plan to meet the current standards updates. By working together with the client’s IT validation team, the Clarkston team ensured the effective development, review, and approval of the Validation Project Plan and documentation.
The plan helped to ensure compliance and functionality of the software in the long term. This included assessing the validation procedures governing the FDA requirements to develop and document the validation process. After developing the documents, Clarkston generated the Operational Qualification and Performance Qualification protocols, including test scripts that mimic the laboratory flow in the LIMS in the client environment and test key functional and operational features of the system.
Overall, Clarkston helped the client ensure that the LIMS solution supports a repeatable process and expected results through the documentation and testing of CSA for a cell and gene therapy company.
