Software used to automate any part of your medical device production process or quality system must be validated for its intended use in order to be regulatory compliant. This requirement applies to software used to automate medical device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.
Validating Your Medical Device Business with 20/20 Vision provides insight you can use when assessing a technology provider’s validation process including:
- The 10 key elements software validation plans, including ERP validation, should encompass
- The three essential elements that direct manufacturing process validation should address