An auditor should provide a clear and concise report relating to an audit to demonstrate and explain all non-compliances observed during the audit.  In addition, it is important that auditees are aware that the responses provided to an audit report are important elements of any audit.  After the effort afforded by the audit team, the auditee should carefully review each observation and provide an adequate and appropriate response.

When responding to the audit observations, the auditee should look at each observation from a systems point of view and not see each observation as a study observation.  Each study specific observation does of course require an adequate resolution in terms of an appropriate CAPA but responding at a study level could mean that the same observation exists in a number of other trials that were not part of that audit.

For example, an auditor notes that for trial 12345-6789-10, the safety monitoring plan had not been completed and approved before enrolment began and that several subjects had been randomised before this key document had been approved.  Any response should include a CAPA for that trial but the auditee should also then review how widespread this observation is within their organisation.  All on-going trials should be reviewed to see whether the auditor had just got “lucky” with that trial or whether there is a systematic issue within the organisation relating to this process.

A CAPA that only covers the trial in which that observation was noted is taking a very narrow view of quality issues.  Responses to audit reports which demonstrate that the auditee has looked “outside of the box” show a true commitment to quality improvement and will undoubtedly improve the overall level of quality within the organisation.

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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