Computer Software Reliability Evaluations (CSA) Recommendations for Laboratory Information Management Systems (LIMS) in the context of a Contract Development and Manufacturing Organization (CDMO) for Cell and Gene Therapy

Computer Software Reliability Evaluations (CSA) Recommendations for Laboratory Information Management Systems (LIMS) in the context of a Contract Development and Manufacturing Organization (CDMO) for Cell and Gene Therapy

In a recent partnership, Clarkston Consulting has worked with a Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapy to implement a LabVantage LIMS system. The collaboration aimed to ensure the implemented solution leveraged a risk-based approach to validation and Computer Software Assurance (CSA) guidance, tailored to the unique challenges of cell and gene therapy products.

The CDMO, with over 25 years of experience in viral vectors and a recognized leader in the commercially approved lentiviral-based gene delivery system, recently expanded laboratories and its Good Manufacturing Practices (GMP) footprint on-site. In response, the company decided to implement a Laboratory Information Management System (LIMS) into the manufacturing process to meet its intended business requirements.

Clarkston Consulting, with its expertise in serialization and traceability programs in biotech contexts, was enlisted to support the development of the project. The team assisted in setting validation process guidelines with a continuous improvement plan to meet current standards updates, ensuring the application's compliance with FDA and EMA regulations.

The Clarkston team developed the risk assessment documents for the solution, designed test scripts to test key functional and operational features of the system, and supported the development and testing of the LabVantage LIMS application. They also collaborated with the client's IT validation team to develop, review, and approve the Validation Project Plan and related documentation.

The partnership's focus on CSA guidance for LIMS in cell and gene therapy CDMOs aligns with the industry's growing need for data integrity, traceability, and compliance. LIMS for these CDMOs must support chain-of-identity, chain-of-custody, and robust data management to ensure product safety and regulatory compliance. The guidance often covers the need for standardized data capture, validation, audit trails, and integration with serialization and supply chain systems to track product life cycles precisely.

While the search results do not directly reference the CSA (Cell and Gene Therapy Contract Services Association) guidance for LIMS in the context of cell and gene therapy CDMOs, Clarkston's experience in lab informatics systems (including LIMS) for regulated industries suggests they are well-equipped to address these challenges. The implementation is expected to result in robust data integrity and traceability throughout cell and gene therapy production, harmonization of master data and regulatory compliance documentation, and development of process maps, SOPs, and training aligned with regulatory expectations.

For precise details on CSA's LIMS guidance as demonstrated in the Clarkston Consulting case study for cell and gene therapy CDMOs, access to the full case study or CSA documentation would be needed. However, this partnership underscores Clarkston Consulting's commitment to helping biotech companies navigate complex data systems and regulatory-driven processes in the manufacturing of cell and gene therapies.

1. The collaboration between Clarkston Consulting and the CDMO focused on implementing a risk-based approach to validation and Computer Software Assurance (CSA) guidance for Laboratory Information Management Systems (LIMS) in cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs).
2. The implementation of the LabVantage LIMS system, supported by Clarkston Consulting, aims to meet the CDMO's business requirements and ensure the system's compliance with FDA and EMA regulations.
3. As part of the project, Clarkston's team developed risk assessment documents, test scripts, and supported the development and testing of the LabVantage LIMS application.
4. The partnership underscores Clarkston Consulting's commitment to helping biotech companies in the manufacturing of cell and gene therapies navigate complex data systems and regulatory-driven processes, particularly in the areas of data integrity, traceability, and compliance.

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