The audit report is the final deliverable, following an audit, and must therefore, be able to communicate, effectively, what was done and what was found, to the people commissioning the audit, as well as the auditees.  This is not an easy task, and many auditing groups are continuously modifying and improving reports to achieve perfection, or as near perfection as possible.

There are many opinions on what a ‘good’ audit report should look like, but this is heavily influenced by the purpose of the report.  ADAMAS standard audit reports include details relating to the audit scope, to allow the recipient of the report to be able to put the observations into context.  Some organisations produce reports which contain only observations, and cut out the background detail.  This is probably acceptable for internal systems audits, but may not present the reader with a clear picture of what was actually audited.

One of the biggest challenges in writing reports is the grading of observations.  It is standard practice to grade observations as critical, major or minor (also may be general or other).  This is one of the most difficult areas in which to achieve consistency between auditors.  Having good definitions for each grading helps, but because the context of the audit observations varies enormously, it can still be very difficult to always achieve agreement.

Agreeing on critical observations is usually achievable because it is often based on a non-compliance that has actually occurred and impacts the rights or safety of the subject or the integrity of the data.  The most difficult area to achieve consistency in the grading is between major and minor.  One solution to this is to ensure all reports are peer reviewed and any disagreements discussed with a third auditor.  However, even though suitable regulatory citations may be used to support the grading, there is often an element of subjectivity, and the best person to make the final decision is probably the auditor making the finding, as they know the most about the context in which it was made.  Because of this element of subjectivity it is unlikely ‘perfection’ will ever be achieved, although it will continue to be strived for!

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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