Computer System Validation

Computer systems validation (CSV) is an area of high focus by regulators.  In this course, we’ll discuss CSV best practices in relation to ALCOA+.  As we have seen with some of the FDA Warning Letters that we’ve covered in previous courses in this data integrity awareness program, inspectors will check to see that the software is validated to have the proper level of control over the corresponding data consistent with ALCOA+ principles.

Assuring data integrity requires appropriate quality and risk management systems and processes, including adherence to sound scientific principles and good (electronic) documentation practices, keeping in mind that there is no loss of quality when an electronic system is used in place of a paper system.

Kyowa Bio Company

Remember the Kyowa Hakko Bio Company FDA Warning Letter that we discussed in the previous course in this program?  The FDA stated in the letter that the company “used unprotected Excel worksheets to perform calculations and statistical evaluations of production data, such as standard deviation and process capability. These electronic files were not secured to prevent unauthorized changes, and have no change history.”

Clearly this was a CSV failure that cost the company dearly after the inspection.

Technology alone cannot eliminate data integrity issues.  There are still people and manual processes involved that must be accounted for, monitored, and improved.  When trying to implement a system and associated controls, remember a team is involved throughout the entire lifecycle.


At a minimum, there must be a team of qualified subject matter experts (SMEs) in the following areas:

  • System/Business Process Owner
  • Technical Representative,
  • Computer System Validation
  • And Quality