By Kevin Ballard, Director of Program Management, MasterControl
Software validation activities often delay an organization’s ability to implement and go live with new software or features. While the FDA requires software validation, it does not specify how to validate.
The goal is to ensure the software will work as expected for your use cases and to ensure that any invalidated or altered records are easily identifiable.
FDA recently published a draft guidance for Computer Software Assurance, which is intended to further clarify how to use a risk-based approach to ensure device quality and patient safety are assured. Leveraging this guidance, this article presents six steps to help reduce the time, pain, and the cost of the software validation process while ensuring the highest levels of quality and safety.