Assessing and reducing compliance risks can now be considered one of the core criteria for business success. While failure mode and effect analysis (FMEA) is widely used in engineering, its application in the financial sector is quite novel, primarily related to compliance risk assessment. This...

Corporate investment in compliance in general and compliance management systems (CMS) in particular, follow the cardinal management obligation to always obey the law (so-called "management duty to legality"). But does the compliance function as any other corporate investment really add value...

This paper investigates the relationship between contract manufacturing and quality risk — a term defined as the propensity of a manufacturing plant to operate out of compliance with required procedures. Contract manufacturing plants (hereafter, CM) are increasingly being used in many...

This document is a statement of policy set by the 1989 Council Decision-Recommendation on Compliance with Good Laboratory Practice [C(89)87(Final). It reiterates the decisions and the recommendations related to the role and responsibilities of governments, national GLP compliance monitoring...