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.Validation testing can be best demonstrated using V-Model.The Software/product under test is evaluated during this type of testing.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 process of evaluating software during the development process or at the end of the development process to determine whether it satisfies specified business requirements.
Moving from current 3 batch process to 3 stage process requires significant changes with traditional validation process and approach.
Verification is concerned with whether the system is well-engineered and error-free.
Validation is the process of evaluating the final product to check whether the software meets the customer expectations and requirements.
To ensure that the product actually meets the user’s needs, and that the specifications were correct in the first place.
In other words, to demonstrate that the product fulfills its intended use when placed in its intended environment.