Constantly striving to learn and improve, IQMS' management team follows a wide variety of blogs written by industry and subject matter experts. Over the past year, we have been struck by a number of articles that we feel need to be shared with our readers. From topics we consider very important to columns that we found inspirational or simply couldn't have said better ourselves, this new blog series is devoted to some of our favorite writers. We hope you enjoy the articles as much as we did.FDA Software Validation: What to do to Validate Quality Computer Systems
By Penny Goss, Consultant at Penny Goss Technical Solutions
By Penny Goss, Consultant at Penny Goss Technical Solutions
Summary: Understanding FDA and IEC requirements for validation of your manufacturing software can lead to a lot of questions. Your software may be compliant, but you are not, and understanding the actual guidelines and best practices isn't always clear. Because the FDA requires that verification and validation activities cover how a system is configured in the manufacturer's environment, there can be no "one size fits all" validation. This guest blog answers questions such as: What systems are considered quality systems, what documentation is required (with brief document definitions), why can't validation documentation be purchased and how do you upgrade or add modules to a validated system. Learn more here.
