It has been proven time and again that necessity is the mother of invention. From the printing press to electric cars, the story is similar. The printing press answered the need for a more rapid dissemination of information during the Renaissance, while the electric car is a response to the need for a zero-emission car today. In regulated environments, the dire need to lighten the software validation burden led to the development of a groundbreaking application.
“We have seen up close the struggle of life science companies in complying with software validation requirements. For most of them, validation is a major burden in terms of time, cost, and manpower,” said Erin Wright, MasterControl’s validation production manager, in a white paper she wrote. MasterControl’s search for ways to streamline and improve the validation process resulted in the development of an innovative approach and tool for software validation.
The requirement for software validation comes from a number of regulations and standards. For companies regulated by the U.S. Food and Drug Administration (FDA), two of the most important regulations that explicitly require software validation are: 21 CFR Part 11 and 21 CFR Part 820 (or Quality System Regulation) for medical device firms.
Part 11 established the criteria for the use of electronic records and electronic signatures by organizations under the jurisdiction of the FDA. Part 820 governs the design, manufacture, packaging and servicing of medical devices sold in the United States. Both regulations require validation of software that impact product quality and safety to ensure that the software is functioning as intended.
Although the FDA requires software validation, it doesn’t prescribe a specific method. Guidance documents such as “General Principles of Software Validation” (2002) and “Guidance for Industry, Part 11 Electronic Records; Electronic Signatures–Scope and Application” (2003) recommend risk-based validation but they don’t include a methodology.
The lack of a prescribed method has always been a source of uncertainty for regulated companies. As a result, Wright said there’s a wide variation in approaches to system validation across the industry.
“Our methodology, MasterControl Validation Excellence (Vx), accelerates the validation process from months to days, if not hours, by combining a best-practice testing and software lifecycle approach with the use of a risk-evaluation tool that focuses on critical business processes,” said Wright in a white paper called “How Necessity Led to a New Validation Methodology and Innovative Tool.”
MasterControl Validation Excellence Tool (VxT), a cloud-based application, is the centerpiece of Vx methodology. The tool streamlines the risk-evaluation process and evaluates multiple risks, such as software usage, impact of failure, regulatory requirements, variation from best practices and testing mitigations.
Janis Olson, vice president of regulatory and quality services at EduQuest, praised the tool for its ability to lower the amount of client work in validation. “This allows the client to leverage the supplier documentation,” she said. Olson’s 22-year career at the FDA includes supervising the NDA/ANDA Program for the FDA’s Atlanta District.
Amber Bawden of the consulting and training firm Axeon said MasterControl’s Vx methodology balances best-practice software testing with customer configuration and deviations to calculate usage risk. “This allows for more focused validation where needed, and at times, no validation at all,” she said.
Olson and Bawden worked with MasterControl as consultants during the development of the VxT.
The new methodology is designed to make validation sustainable and cost-effective by making the process repeatable with every software upgrade. “The path toward validation compliance may be long, but we hope to make the journey faster, less expensive, and less cumbersome with the help of the right tool and approach,” said Wright.
Cindy Fazzi writes about the life science industry and other regulated environments for MasterControl. She has worked as a journalist in three countries. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York City. She has a master’s degree in journalism from Ohio State University.