Computer System Validation
Ensuring regulatory compliance in HLS
with Computer System Validation processes
Learn more about Microexcel’s Computer System Validation solutions, and the way they enable statutory compliance in the HLS sector.
Computer System Validation (CSV) is a compliance process to ensure that the software tools and technology environment in Healthcare and Life Sciences (HLS) industries comply with FDA norms and meet the standards set down for the industry.
CSV is essential to validate that software and applications are certified for safety and efficacy and meet the intended requirement with precision and accuracy.The Food and Drug Administration (FDA) defines CSV as
“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” – General Principles of Software Validation: Final Guidance for Industry and FDA Staff
The validation is carried out in regulated companies to prove that their systems, software, and processes are working as per the intended functionality, and do not deviate from the prescribed norms. The compliance with FDA regulation and guidelines is crucial in the Healthcare and Life Sciences sector, owing to the criticality of their operations.