Electronic Music & Artists
If a system has been changed since August 20, 1997, and if the changes would prevent the system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 records and signatures pursuant to the enforcement policy expressed in this guidance. These concerns have been raised particularly in the areas of part 11 requirements for validation, audit trails, record retention, record copying, and legacy systems. Electronic systems design deals with the multi-disciplinary design issues of complex electronic devices and systems, such as mobile phones and computers. 7 In this guidance document, we use the term legacy system to describe systems already in operation before the effective date of part 11. We believe that some of those broad interpretations could lead to unnecessary controls and costs and could discourage innovation and technological advances without providing added benefit to the public health. As a result, we want to clarify that the Agency intends to