Various laws, standards, and guidelines place stringent requirements on firms in the regulated industries; compliance to completion of these requirements is often a first step in gaining access to the market and consumers. GxP, Annex 11, cGMP, 21 CFR, ISO 9001, and ISO 13485 etc. are among the relevant requirements.
Adjustments to specific parts and interpretations of regulatory requirements have to be anticipated proactively, evaluated correctly, and implemented efficiently. This approach is crucial for your organization’s compliance.
A company’s quality management system (QMS) is a key success factor in the implementation of such activities to ensure compliance.