Regulatory assessment, integrate

During the assessment process, there is a documented interactive dialogue between each assessor and the applicant to clarify points that are complex or ambiguous or to enable the applicant to provide additional raw data, statistical appendices and detailed protocols to facilitate the assessment process. However, none of the various parts of the dossier is self-standing or independent of others. There are areas within each, which are intricately linked to the others. In preparing a comprehensive and integrated regulatory assessment report, it is important that these areas of common interest are appropriately addressed. 

Banard R.C., (1996) A New Approach to Risk Assessment Integrating Scientific Evaluation and Economic Assessment of Cost and Benefits , Regulatory Toxicology and Pharmacology, Vol. 24, pp. 121-125. 

Program Plan for an Integrated Risk Assessment Data Acquisition Program. U. S. Nuclear Regulatory Commission, September 1982. 

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. 

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