As contract auditors, the one area that we are frequently asked to reduce time for in proposals is preparation. I often wonder whether the client company realises what a false economy this actually is. Unfortunately, this is usually a decision made by the finance or contracts group who have a poor understanding of what is actually involved in preparing for an audit, and are merely concerned about cost. ADAMAS has always emphasised that preparation is the key to a thorough and successful audit. However, how much preparation is enough? There is a balance between doing enough preparation to ensure the audit progresses smoothly, to going overboard and spending a great deal of time reading documents that could be read during the audit, or that have no real relevance to the audit.

For pharmacovigilance (PV) systems audits this can be a particularly difficult balance. I have received up to 120 different documents to read before starting a PV systems audit – which is somewhat difficult to achieve, even with a generous preparation time of three days! This can be contrasted with service provider qualification audits, where one often just has a contract, organisation chart and list of SOPs, as well as the website information.

The view we take at ADAMAS is that you should have read enough information to be able to prepare a detailed audit plan and agenda, and to understand the scope of the audit thoroughly, so that the auditor can walk into a site or organisation feeling confident that they know what needs to be done, and avoid looking confused and muddled – this would not be good for their credibility (which is extremely important for an auditor).

It’s also not recommended to prepare whilst travelling to the audit! Although some clients have asked us to do this – we rarely do. We believe in keeping client information confidential, but also it is not good practice to leave preparation to the last minute.

In summary, good quality and efficient preparation is important to the overall success of an audit and delivery of a quality product.

The ADAMAS Corporate Brochure 2016

 

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

×
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.

 

×
How to be a Clinical Auditor

 

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

×
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.

×
Is your QMS compliant?

 

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

×
ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

×

×