Event Description:

The scope of computer systems is defined to include hardware, software, peripheral devices, personnel and documentation. Regulatory agencies recommend a practice of “risk-based” validation processes for ensuring the safety of electronically stored data. Regulatory and accrediting agencies have established standards and guidelines that relate to the process of implementing, modifying, and maintaining these systems and electronically stored data. This seminar will review some of the aspects of these recommendations and standards. The review will discuss processes of creating a validation plan for software validation and the expected outcomes of validating systems. Included in the discussion will be topics of the assurance of personnel competency and prevention of unauthorized access to computers and electronic records.