Medical device companies are required to validate enterprise software that is part of the quality system to ensure all functionality meets the software’s intended use. Detailed in 21 CFR 820.70(i) and 21 CFR 11.10(a), these multilayered requirements can have a major impact on business operations in the form of high costs and significant time demands on team members.
Many organizations find the process so punitive, in fact, that they choose not to install updates, upgrades, and bug fixes at all. Those decisions lead to a dangerous mismatch of cutting-edge technologies being managed by old, outdated enterprise software.
Challenge: How can medical device companies benefit from software updates and make the validation better?
Arena Validate simplifies validation so that organizations can reduce costs and the work required by internal quality and regulatory teams. This straightforward approach is comprised of three steps: