Introduction In September 2022, the U.S. Food and Drug Administration (FDA) released a draft guidance on software validation, introducing a new approach called Computer Software Assurance (CSA) for production and quality system software. This guidance marks a shift from the traditional method of software validation, known as computer system validation (CSV), towards a risk-based approach….
A new Warning Letter has been issued by the U.S. Food and Drug Administration (FDA) and published on their website on August 1, 2023. The document, dated July 28, 2023, pertains to an inspection from November 22 to December 2, 2022, at a drug manufacturing facility in Sanand (Gujarat, India). The company under scrutiny is…
Computer system validation (CSV) in the pharmaceutical industry refers to the process of ensuring that computer systems used in various critical functions, such as manufacturing, quality control, and data management, are operating in a controlled and consistent manner. CSV is essential for ensuring data integrity, patient safety, and compliance with regulatory requirements. The CSV…
