Implementation of FDA’s Design Control requirements (21 CFR 820.30) changed the entire medical device and diagnostic industries. The quality system requirements define the approach to medical device validation, product design, manufacturing process and test method validation studies. Validation studies must demonstrate that product design, processes, test methods, requirements and specifications determined during development are met in the environment the product is used.
Medical device validation is a complex process that must be completed and documented prior to releasing products into market so as to meet the strict regulatory requirements including those of the FDA. Success in the medical device market requires adherence to applicable FDA regulations and international standards – ISO 13485, ISO 14791[these are not FDA regulations], 21 CFR 820 and 21 CFR Part 11. The FDA believes that through careful design and software validation of the process and process controls, a medical device manufacturer can establish a higher degree of confidence in delivering a safe product. Successful validation of a process will reduce the dependence on intensive in-process and finished product testing.
The current validation process is predominantly manual and paper based, yet paper-based manual validation processes stifle innovation, cause compliance risks and compromise a medical device firm’s ability to bring products to the market on time. Inefficiencies in the validation process cost regulated manufacturers millions of dollars annually, mainly attributed to the use of paper or paper/hybrid systems.
ValGenesis completely replaces the inefficient paper-based validation process with a 100% paperless, electronic system. ValGenesis’ unique technology manages the entire validation process end to end, dynamically tracking validation status in real time, streamlining the process, improving communication between all stakeholders and ensuring/enforcing compliance and consistency throughout the whole corporate validation process. ValGenesis helps to implement and enforce a uniform set of validation standards and procedures that are typically scattered in validation master plans, SOPs and policy documents across the organization.