IEC 82304-1 and its Application for Stand-Alone Software
IEC 82304, in conjunction with IEC 62304, plays a critical role in the realm of software-based medical devices. While these…
Requirements Traceability Matrix
Traceability for Software Validation Activities In the framework of software validation, it is of fundamental importance to maintain full traceability…
GAMP-5 Guidance for Computer System Validation
GAMP-5 guidance, the related “V model” and the different software categories used to simplify the validation activities are nowadays considered…
21 CFR Part 11: Requirements for Electronic Records and Signatures.
Introduction of 21 CFR Part 11 Requirements FDA 21 CFR Part 11 defines the requirements for the management of electronic…
IEC 62304:2006 – Medical Device Software
IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of…
Computer System Validation
Introduction Computer System Validation (CSV) is an extremely important subject for Quality Management System of highly regulated companies; software .…