Computer systems regulatory requirements analysis

Compliance assessments for computer systems are performed periodically, based on the applicable predicate regulatory and Part 11 requirements. These assessments must be performed in order to identify any functional gaps, and/ or procedural gaps, which may be present for each computer system implemented. The analysis will determine if operational, maintenance or security controls, specific to the system, provide a controlled environment ensuring the integrity of the electronic records and/or signatures as stated in the regulatory requirements. Additional information can be found in Chapter 19. 

The handbook additionally provides an extensive overview and comparison of commercially available computer systems and software for chemical emergency planning. This section provides technical guidance for hazard analysis and identification implementing regulatory requirements and descriptions of computer applications and systems applicable under SARA Title III. 

The process of NPP I C systems V V and expert analysis of V V includes the stages of verification and validation and expert analysis of V V both algorithms and software (A SW). The quality of A SW V V execution is very important for the computer-based critical I C systems reliability and safety ensuring. The requirements for verification have actually become more strict and methodology of V V is the subject of regulatory bodies assessment. The problems of regulation of V V are inseparable components of both national and international standards in critical engineering [1-3],... 

---