Before starting any type of CSV project, it’s important to create a strategic plan. The plan should detail the goals and objectives of the validation, include a business and workflow analysis, and define the necessary functional and user requirements. These requirements should be clear, specific, and reflect your unique environment to ensure the system will work as intended.

A crucial next step is to develop a plan for the validation processes. This plan should include an explanation of how you will achieve continuous validation throughout the software development life cycle (SDLC) and compliance with regulatory requirements and industry best practices.

The validation plan should also include the scope of the project, the approach to testing, a list of all team members as well as their roles and responsibilities, and the requirements necessary for the system to be validated.

Focus on computer system validation in the areas with the highest risk and impact on your manufacturing processes. Work with a CQV expert that can demonstrate an efficient use of ISPE GAMP 5 guidelines to stay within important business and regulatory areas while eliminating redundant testing during the CQV activities at your gene therapy facility.

The most successful CSV projects are comprised of structured knowledge and clear documentation about standards, processes, and logistics. This approach enables well-informed decisions, leaves no room for error, and ensures all team members are working together in an efficient way.

Your documentation should include a clear definition of the approach, address redundancies or conflicting information, match with the high-level guidance, and prioritize teamwork. It’s also important to include potential challenges, obstacles, and what-if scenarios — and guidance for how they will be addressed.

More complex technologies are being added to labs and manufacturing suites to increase efficiencies and safety. Cloud-based technologies such as infrastructure as a service, platform as a service, and software as a service can help reduce costs, improve flexibility, boost scalability, and quicken responsiveness to changing business needs.

Keep in mind, however, that each type of technology requires a different validation strategy to accommodate for server and application qualification and data validation.

On the CSV side, digital solutions that offer validation automation help to reduce errors and risks while driving efficiency. Companies that embrace technology innovation and automation from all angles will be best positioned for efficiency gains.