Computer systems validation ensures that computerised systems used in regulated industries, such as pharmaceuticals, healthcare, and finance, comply with regulatory requirements. It helps organisations meet the standards set by regulatory bodies like the Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Computer systems validation projects face high costs due to a lack of specific implementation guidelines, complicating the determination of the best validation approach. Maintaining compliance during system upgrades is challenging, while improper role distribution and limited cross-functional coordination cause delays and inefficiencies, emphasising the need for effective teamwork.
InspireXT provides accelerated computer systems validation (CSV) services tailored for life sciences organisations. By employing a risk-based validation approach, we ensure compliance with international regulations, offering a faster and more efficient validation process.
InspireXT follows a comprehensive methodology where infrastructure, installation, and software undergo rigorous testing and qualification ensuring GxP compliance. User acceptance testing is conducted with clients to verify that the validated system meets their specific requirements. These streamlined methods eliminate the need for clients to allocate extra time and resources to validation, enabling them to prioritise research and development efforts.
Find out more about how we can help your organisation navigate its next. Let us know your areas of interest so that we can serve you better.