ABSTRACT
This chapter discusses expectations by key regulatory agencies, expectation by worldwide entities, e-records integrity, and a summary. It provides the expectations of Therapeutic Goods Administration's inspectors on electronic records: Data may be recorded by electronic data processing systems, photographic or other reliable means, but detailed procedures relating to the system in use should be available and the accuracy of the records should be checked. The chapter defines all the tasks required for developing and maintaining software. It provides recommendations and background information concerning computer systems that will be of assistance to inspectors for training purposes and during the inspection of computer systems. The chapter presents and briefly discusses the latest regulations and guideline documents impacting the requirements applicable to computer systems in the manufacturing environment. There is a notable amount and quality of the regulatory requirements and regulatory guidelines provided by the worldwide regulatory authorities.
