USDM performed a thorough risk assessment on all requirements (functional, user, system) and completely revamped the traceability matrix, reducing the total number of regulatory “required” requirements
- Read on to learn the exceedingly positive outcomes of this approach achieved through proven cost and time saving mechanisms.
- Reduced the number of requirements by almost 90%!
- Reduced the company’s original timeline for validation by over 80%
- Oversaw all validation activities from conference room pilots to final implementation resulting in a smooth transition to the new version, and also setting the company up for the next version upgrade
TOTAL Estimated SAVINGS on total validation effort!
Requirement drop from original to current via risk based validation resulted in less time, less reso