Mark Poulton recently presented a presentation at an RQA regional forum meeting (Scotland and English Borders, 29-Jan-15) entitled “Audit vs Inspection”.

This presentation was intended to awaken minds to the similarities between audits and inspections and to make suggestions to improve quality in all research areas.

Mark opened by looking at the terminology and demonstrated the strong similarities between the two terms. He then highlighted the differences between the two activities, but in oversight terms and staff terms rather than real measureable terms. He then described the attitudes and mind-sets associated with the two and made comment that there were two mind-sets of clinical operations associated with audit:

1. “We are all working for the same company and the outcome can affect us all”

2. “You damned auditors just interfere with our systems and work”

He highlighted the need to display the second mind-set and to avoid the “them” and “us” mentality often associated with audit. He pointed out that both QA and Clinical should learn from an audit, clinical about the audit process and the reason why things are important and QA about the clinical processes and issues associated with trial management.

Mark highlighted the low emphasis often placed on audit, and highlighted the need to consider inspections and audits as equal, and to prepare for them and treat them the same.

He concluded by stating that by treating audits and inspections differently, organisations are not gaining benefit from either of these important tools and that organisations should consider both as essential tools in the continual assessment and improvement of quality.

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.

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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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