FDA Validation

Companies in the pharmaceutical and health care industries require more of their Enterprise Business Solutions than their counterparts do in other industries. Often, the first question asked would be--- Is this system FDA validated?

FDA validation is critical to assuring product quality for software automated operations. Furthermore, software validation is a requirement of the Quality System Regulation, 21 CFR Part 820. This requirement applies to any software used for manufacturing, labeling, packaging, distribution, complaint handling or any aspect of quality management. Such software may be developed in-house or under contract, but it is most likely to be an ERP system purchased for a particular intended use.

Sysbiz Technologies understands that deploying an ERP system is simply not enough for our pharmaceutical clients. During all phases of deployment, we focus on mission critical results including 1) Business and IT objectives, 2) Class A processes and 3) FDA validation. We document the requirements that fully define the intended use of the ERP solution, and against which testing results and other verification evidence can be validated. We understand the complex subject of software validation. Through our work with the FDA, we recognize that although software validation may sound like software testing, the FDA uses this term to encompass the entire software development lifecycle.

As a result, our successful approach includes both structural and functional validation. Structural validation ensures that:

• Software logic has been developed to perform in accordance with the functional specifications.
• The software performs in an efficient, concise and reliable manner.
• All logic paths are complete and terminate logically.
• Single entry and exit points have been used.
• Programming and development standards have been incorporated.

Functional validation ensures that:

• Testing is performed without regard to source code lo gic.
• The software satisfies its intended use.
• Data integrity is maintained.

Our clients know that the benefits of software validation are significant. Validation can increase the usability and reliability of the ERP software to streamline processes, resulting in decreased incident reports, fewer recalls and/or corrective actions, and reduced liability.