Smart regulatory requirements

In this day and age any company that attempts to operate an FDA-regulated facility without a fully operational quality assurance department is asking for severe regulatory actions by the agency. There is no justification for even the smallest FDA-regulated firm to operate without some degree of quality assurance and quality control. Not only is this a regulatory requirement, it is smart business sense. 

Regardless of the laboratory s mission, managers are confronted with a common set of problems Increases in data volume from increased use of smart instruments and from increased testing and record retention requirements imposed by ERA, FDA, OSHA, and other regulatory agencies constantly rising operating and material... 

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