Practical does not always mean Cheaper or Faster

A CRO hired The Practical Solutions Group, LLC to serve in the capacity of QA to oversee the CRO’s user acceptance testing regarding its major regulated computerized system. Our initial review of the executed test scripts and testing anomaly documentation resulted in identifying multiple documentation-related gaps. We suggested to the CRO’s executive management team that the user acceptance tests be re-written and the testing re-executed, with a documented explanation, because the documentation would not withstand audit scrutiny from existing/potential clients or from FDA. Our advice was taken to heart even though it meant expending more time and resources. The management’s decision paid off: more than 2 years later, and after more than 10 audits from major pharma and medical device companies, there was not one observation issued to our client regarding the validation of its major regulated computerized system! “Practical” does not always mean “cheaper” or “faster”; sometimes “practical” means “sacrificing short-term objectives in order to assure long-term success.”