Risks in Regology are the regulatory risks associated with non-compliance with a given regulation, including penalties, adverse economic impacts, withdrawal of a license to operate, and more. On the Regology platform, Risks can be associated with Authoritative Documents or created as standalone risks. Risks are generally mitigated by creating Controls and complying with those Controls.
These Risks could stem from multiple sources, ranging from (but not limited to) failure to capture the requirement, inaccurate understanding of the requirement, inaccurate understanding of the business (products, functions, processes, IT systems, etc.), incomplete or inaccurate control for the risk or requirement, misstatement of compliance readiness, estimation of compliance evidence, or inaccurate capture of the evidence.
The Risk of misstatement of regulatory readiness is generally greater when regulatory readiness assessments include estimates rather than factual data and evidence substantiation. Some examples of estimates are inventory obsolescence and uncollectible receivables.
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