Credentialing regulation

Because of the complexity of computer hardware and software and because of the intricacy of a risk assessment, the FDA has to all intents and purposes adopted an indirect regulatory posture. Regulated companies are informally urged to conduct independent audits of Part 11 compliance, utilizing in-house or consultant expertise. The agency can then review the details of the audit report and the credentials for experience, expertise, and independence of the auditor. Follow-up investigation of speciflc points can then be laser-focused on specific areas of concern. 

They are somewhat controversial with regard to their green credentials among some members of the public, the scientific community, and even other federal agencies [30-32]. They also are assessed for risk and regulated somewhat differently from either conventional chemicals or the other two categories of biopesticides [29]. 

The laboratory to be inspected will receive a letter approximately two weeks before the Agency inspection team arrives that specifies which studies will be audited and if a laboratory GLP inspection is to be included. Upon arrival, the inspector will present official credentials and a Notice of Inspection form. The GLP portion of the audit is now conducted as if GLPs for all types of studies were in effect. For those laboratories conducting non-GLP studies, this is done to give an idea of what to expect when, and if, the GLP regulations become law. The laboratory inspection aspects will be reviewed briefly and then the data audit portion will be discussed. 

A person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The investigator should have qualifications and competence in accordance with local laws and regulations as evidenced by an up-to-date curriculum vitae and other credentials. Decisions relating to, and the provision of, medical or dental care must always be the responsibility of a clinically competent person legally allowed to practise medicine or dentistry. 

Defining appropriate expertise is even more complex. The FDA informally recognizes the expertise and hence the credentials of some individuals, but does not provide any formal certification. This recognition seems to be based on a combination of experience, academic credentials (in computer systems, regulation, and laboratory management), and general familiarity. (The more often an investigator successfully reviews a laboratory audited by a specific validator the... 

It is submitted that there is more to be gained from a consideration of regulatory enforcement as a moral endeavour than a straightforward endorsement of the regulator s normative credentials. While responding... 

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