Validation

In the United States since the mid-1980s, for example, the Food and Drug Association (FDA) has enforced validation of software and computer systems in pharmaceutical manufacturing for consumers’ safety. In response to this important industry need, the industry has created special task forces with the primary mission of developing guidelines for computer and software validation—known as the Computer System Validation Committee of the Pharmaceutical Research and Manufacturing Association (PhRMA). Probably the most important industry task force for computer validation is the Good Automated Manufacturing Practice (GAMP) forum.

The basic principles behind software validation are as follows: Specify the intended use of the software and user requirements; verify that the software meets the requirements through proper design, implementation, and testing; and maintain proper use of the software through an ongoing performance program. Similarly, for computer validation one should ask, “What is this computer system intended to do, and how can I ensure that this system meets the requirements?”

Successful computer and software validation “best practices” include these steps: Develop a validation master plan, including a glossary and recommendations for risk management; form a validation team with members of all departments who are affected by the computer system; develop a validation project plan, including a risk assessment; develop specifications, including user requirements and functional specifications; design and develop appropriate code, or select a suitable vendor and product; verify the proper installation of the hardware and software; perform functional tests to determine whether the system functions as specified in the functional specifications documents; verify that the system meets the user’s requirement specifications, as defined in the functional specifications documents; develop and implement procedures to check whether the system performs as intended during long-term usage, including planned and unplanned changes; and develop a validation report.

See Also: Verification.