If the brakes fail, your customers won’t let you take them for another ride. Recognize that functional applications are a requirement, not an enhancement.In order to comply with c GMP, companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs), Master Production Batch Record (MPBR), Production Batch Record (PBR), Equipment log books, etc.This white paper uses that FDA guidance as an input to define an “easy-to-implement” framework for systems validation.Finally, the paper identifies a best practice, which calls for IT organizations and software vendors to proactively audit their software development and implementation processes on an ongoing basis to identify and correct any systemic issues to lower the cost of compliance. Current Good Manufacturing Practices (c GMP) are mandated by the FDA to ensure that the products manufactured by the industries such as pharmaceutical, biotech and medical devices, meet specific requirements for identity, strength, quality, and purity.The regulation outlines controls for ensuring that electronic records and signatures are trustworthy, reliable, and compatible with FDA procedures and as verifiable and traceable as their paper counterparts.Hence, 21 CFR Part 11 also specifies a number of requirements for software systems to enable trustworthy and reliable electronic records and signatures - see Figure 1.These software requirements must be met for the resulting electronic records to comply with FDA's c GMP.If an organization does employ electronic records and signatures, but fails to comply with these system requirements, the FDA will cite the firm for violating the underlying regulation.
Adding new software requirements adds cost and time to the software development process. Include all stakeholders in the requirements definition phase. Have a strict definition of the requirements definition phase.
Here’s The Difference Between the Software Validation and Software Verification Software validation is determining whether or not an interface with a website or another software application is necessary.