Regulatory Impact Analysis data required

Some conclusions can nevertheless be drawn. It seems clear from the survey research data that the American public is concerned over the increase in social regulation, and that there is growing interest in introducing the cost factor into agency considerations. It can reasonably be concluded that, so long as Executive Order 12291 requires regulatory impact analysis, cost-benefit analysis will play that function. Nevertheless, the nature of the debate is very likely to change in ways not yet anticipated by the present participants. 

Electronic records requiring particular regulatory control should be identified based on critical process control points and associated critical parameters that directly impact product quality or product safety. A defined process should be used to conduct this analysis, and it should be one that builds on or is complementary to any assessment conducted as part of product registration. Consistency is key. There may be additional records identified by predicate rules but care must be taken not to extend beyond these records. A risk assessment should be conducted to determine appropriate electroific record management controls such as audit trail and archiving. Electronic records will need to be archived for retention periods specified in predicate rules. Other data related to process performance rather than product quality or product safety requires only basic data maintenance and may be retained for much shorter periods before being purged. 

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