IEC 82304, in conjunction with IEC 62304, plays a critical role in the realm of software-based medical devices. While these two standards may appear similar at first glance, they actually

Traceability for Software Validation Activities  In the framework of software validation, it is of fundamental importance to maintain full traceability during the whole entire project and in this context the requirement

GAMP-5 guidance, the related "V model" and the different software categories used to simplify the validation activities are nowadays considered the internationally recognised best approach for computer system validation. GAMP

Introduction of 21 CFR Part 11 Requirements FDA 21 CFR Part 11 defines the requirements for the management of electronic records and electronic signatures. It is one among the best known

IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of software used as or within medical devices. It