Process and Quality System Software Validation

Regulated software includes applications that manage quality records (e.g., spreadsheets, management software) as well as software used in production processes or as measuring tools. Such software must be validated, especially when it is used to ensure device safety or to generate information for regulatory authorities.

Software validation helps reduce risks and legal liability, while providing documented evidence that the IT system is fit for its intended purpose.

In ISO 13485:2016, software validation requirements have become more explicit. Similarly, 21 CFR 820 (QSR) has long required these same validation standards for medical device and IVD companies intending to market their products in the USA.

With over a decade of experience in software validation, Maytal can support companies to:

• Develop validation and revalidation procedures and protocols for regulated software

• Implement a practical and efficient approach, proportionate to the level of risk

• Execute validation and revalidation procedures, prepare validation reports, and guide/train internal personnel managing the validated software

• Train internal teams and suppliers to ensure revalidation is performed correctly whenever the software is modified