Validating software process
The FDA (Food and Drug Administration) and IEC (International Electrotechnical Commission) requirements for validation of your manufacturing and quality system software can conjure up a lot of questions.Understanding the actual guidelines and best practices for meeting these requirements isn't always clear.The systems in red typically affect multiple business units within the organization, most of which are Configurable-off -the-Shelf (COTS) software systems.These systems allow you to configure the software to meet your business needs.For automating websites my weapons are QTP and Selenium (Web Driver JAVA & C#).I live in London (UK), with my wife and a lovely daughter. An additional challenge is that traditional process validation is a paper-based very inefficient and time consuming process.Paper-based process validation lifecycle creates a significant amount of challenges while managing the process validation lifecycle as per new process validation guidance.
You will encounter (or have encountered) all kinds of usage and interpretations of those terms, and it is our humble attempt here to distinguish between them as clearly as possible.For majority of the regulated life science companies, the guidance created a systemic shift in the expectations of their validation programs.Moving from current 3 batch process to 3 stage process requires significant changes with traditional validation process and approach.Your software may be compliant, but you may not be.This article provides answers the top five most common software validation and documentation questions asked by others in FDA regulated industries and demonstrates best practices for meeting the guidelines. The FDA mandates that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use shall be validated.