Written by: Gary E. Ritchie, MS, Senior Validation Engineer Consultant, PSC Biotech Corporation 

The FDA will release the draft guidance on Computer Software Assurance for Manufacturing, Operations, and Quality System Software in late 2020. The new draft guidance will apply critical thinkingassessmentand risk tools for assuring that data for the manufacture of drugs and devices meets their product quality specifications, ensure patient safety, and conform to data integrity requirements for complete, consistent and accurate records throughout the computer software lifecycle. The new approach in this draft guidance differs from the current validation approach in several ways, as it is a shift away from a compliance approach to a quality assurance approach.    

Although the draft guidance will be issued by the CDRH, you know that FDA will apply it Agency-wide, which means you need to know what FDA will expect. The change to a quality focused approach comes out of the FDA’s The Case for Quality (CfQ) Program, launched in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders.     

FDA envisions that a focused and leaner approach will lead to reduced documentation and faster qualification of computer software before, during, and after manufacturing, testing and releaseFDA expects that the new framework will assure that requirements for computer software, hardware, and integrated system maintenance, change control, qualification, verification, validation, and data integrity are met through this quality and risk-based approach. 

Since automated computer controlled systems and software are often also used in in the production of biologics and drugs, the guidance will impact these areas as well. 

FDA wants to ensure that you have adequate controls in place for your computer software and systems. You will get increased product and patient safety and reduced risk wherever data is used and generated by software and automated computer controlled equipment. PSC™ can help meet your quality needs for computer systems quality assurance under this new paradigm.