Software Validation Keeps GxP Systems Current And Speeds Up Time-To-Market

By Fran Carmody, Services Enablement Manager, IDBS

Industry insiders warn that with more scrutiny on software processes, they expect the Food and Drug Administration (FDA) to issue more warning letters on product software validation – the process of ensuring that a software product meets a user’s demands and expectations. In recent years, global regulatory agencies, including the European Medicines Agency (EMA), have followed the FDA’s lead in citing deficiencies in computer and software system validation, particularly regarding GxP-regulated activities.

As part of the 2002 final guidance on General Principles of Software Validation, the FDA requires that pharmaceutical companies demonstrate and document that their software accurately and consistently produces results that meet predetermined guidelines for compliance and quality management.³ Requirements to maintain a GxP environment and the need to understand how the system works mean that life sciences researchers must ensure that any updated software continues to meet the needs of all who use it and that it functions as designed.