Industry Common CSV Pain Points

Data Integrity App


Industry Common CSV Pain Points

USFDA and Industry working group of Computer System Assurance (CSA) identified the common pain points of the industry in implementation of new technologies with traditional CSV methodology

I Deterrent to pursuing automation: 

The volume of documentation and complex process of computerized system validation deter the rate of investment (ROI) on implementation of new technologies and automation.


II. Gathering evidence for auditors: 

The lack of knowledge and understanding on the regulatory expectations on CSV forced the industry to collect the evidence for each function in the computer system beyond the intended scope to please the auditors. This process of gathering the evidence doubles the CSV process implementation time.


III. Duplication of vendor efforts at client sites: 

The failure in exploring the product and supplier maturity and inexperience in communication with vendor results in customer to repeat the activities, during implementation of computerized systems onsite.


IV. Burdensome and complex Risk Assessments: 

The traditional risk assessments are applied beyond the scope of intended requirements, shifting the focus to unintended mitigations, burdensome testing, and implementation of unnecessary controls.


V. Testing documentation and errors: 

It is observed that high number of deviations in the testing occurs due to the test script errors and the time spent on correction and resolution of these errors does not add any additional value to actual computer system.


VI. Numerous Post- Go Live Issues: 

Despite spending huge amount of time on creation of validation documentation and testing, numerous Post-Go live issues are observed

 

 “Trust but Verify “ Ronald Reagan

 

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