Paperless Validation for Medical Devices and Diagnostics

Our unique solutions manage the entire validation process end to end, dynamically tracking validation status in real-time, streamlining the process, and improving communication between stakeholders while ensuring/enforcing compliance and consistency throughout the whole corporate validation process.

Medical device validation can be a complex process, and it must be completed and documented before releasing products into the market to conform with regulatory requirements (FDA, EU, etc.). Continued success in the medical device market requires adherence to applicable regulations and international standards, such as ISO 13485, ISO 14791, 21 CFR 820 and 21 CFR Part 11. Through careful design and software validation of the process and its controls, a medical device manufacturer can establish a higher degree of confidence in delivering a safe product. Successful validation of a process will reduce dependence on intensive in-process as well as finished product testing.

Much of the current validation processes are predominantly performed manually in a paper-based environment. Sadly, such environments stifle innovation, cause compliance risks, and compromise a medical device organization’s ability to bring products to market on time. Validation inefficiencies can cost medical device manufacturers millions of dollars annually, mainly due to the use of paper (or paper hybrid) systems.

ValGenesis VLMS completely replaces the inefficient paper-based validation process with a paperless electronic system. Our unique solutions manage the entire validation process end to end, providing dynamic tracking of validation status in real-time, streamlining the process and improving communication between stakeholders while ensuring/enforcing compliance and consistency throughout the whole corporate validation process. The ValGenesis VLMS helps to implement and enforce a uniform set of validation standards and procedures that are typically scattered and buried in approved validation master plans, SOPs, and policy documents.