 ART Updates - Management of Change
The final component of Citation Technologies’ Compliance Continuum, and possibly the most valuable, is ART Updates.
Without question, a compliance assurance system must have the capability to manage change (MoC). ART supports a high quality MoC process by periodically updating regulatory data. Users are notified of any new, changed, or repealed requirements since the last applicability review was performed. These changes are presented in the same layman’s language approach used during the initial applicability review. Included in the ART Update is an explanation of the regulatory change as well as summaries and lins to the actual requirement.
ART Updates enable the applicability review team to
- determine applicability of all new requirements,
- decide whether to delete compliance activities for repealed requirements or to continue them as supplemental requirements, or
- review changed requirements to determine if previous applicability decisions need to be revised.
MoC Compliance Requirements are derived from ART Updates. The MoC Incremental Matrix enables site personnel to add, change, or delete compliance activities for only those requirements that are new or have changed thus reducing the MoC effort dramatically.
Having the direct link from applicability determination to the site's compliance activities will enable an ongoing, sustainable compliance assurance system.
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