For example, in the US, FDA needs the pharmaceutical sector to perform CSV on systems that support the production of medical devices, drugs, blood & blood components, infant formulas, human cell & tissue products, and biological. CSV is essential while new system configuration or upgrading a validated system.

The computer systems validation processes are based on guidelines, regulations, and best practices. You can learn more about the standards of CSV planning and execution on the blog GMPSOP.

According to FDA the general principle of software validation - ‘“Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”.

All the CSV activities that need to be documented are -

• System inventory & assessment - Defines which system needs validation.

• User requirement specifications - Describes what the system has to do and even its operational limitations.

• Functional requirement specifications - Outlines how the system looks and performs for users.

• Validation plan - Sketches validation goals and how to maintain validation grades.

• Validation risk assessment - Defines how to analyze validation effort scope in case of failure.

• Validation traceability matrix - Outlines how to cross-reference between functional and user needs to confirm that everything is verified.

• Network & infrastructure qualification - Summarizes that the network & infrastructure associated with hardware & software is installed correctly and performing as proposed.

• Installation qualification scripts & results - Examine the installation accuracy.

• Operational qualification scripts & results - Examine the system to see if it does what it is anticipated to do.

• Performance qualification & results - Scrutinizes the performance of the system with trained users following SOPs [Standard Operating Procedures] during production even in worst scenarios.

• Validation report - Review of every CSV activity and validation plan document.

• System release documentation - Documents stating that validation activities are finished and the system is released for the intended use.

Best practices for CSV process

• Follow a risk-based system assessment to stay focused on what is useful and doable for quality assurance and compliance. Avoid vague test scripts because precise validation testing confirms systems perform as intended.

• Develop a clear and detailed validation plan focusing on user requirements. The VP must outline the project scope, testing approach, acceptance criteria, and even the responsibilities of the testing team.

• Create a team with CSV experience and awareness about the validation process, compliance guidelines, lab processes, and technology. The team must have sufficient members so that there is no stress during the validation process.

• The CSV activities & results have to be documented clearly. It has to pass the regulatory agencies' audits, to ensure that all the required documentation is created for submission.

• If 3rd party service providers or vendors [CROs or SaaS] are used then the manufacturer has to partner with those that operate under standards, which hold up under FDA audit