As a service company we keep in mind the old adage that ‘the customer is always right’.  But is this really appropriate in QA?  I guess you would say it depends on who the customer is.

In our business, the customer is the company/person that commissioned the audit/quality consultancy, but they could also be the auditee.  This is also the case for most QA functions within companies, and could potentially put the QA company/function in a very tricky situation; how to meet the customer’s demands and expectations, whilst maintaining independence.  The outcome of the audit may not always be what they expect, or want to hear!

There can be situations where the customer tries to apply pressure to QA, to make the outcome of the audit look more favourable than it is.  This may be for financial or regulatory reasons.  The customer may be submitting a licence application for approval, or they may be licensing out a product, and want to provide assurance to the buyer that the data is of a high quality.  Bad news, following the audits, could adversely affect the success of the submission or the business deal.   QA may find itself in a dilemma.  Does it do it’s best to meet the customer’s needs and potentially compromise the integrity of the audit?  Or does it stand its ground and risk losing future business with the customer or possibly losing their job?  It does and has happened!

In ADAMAS, we believe strongly that there must not be undue influence from auditees, whether they are the customer or not, in the output from audits.  QA’s integrity and credibility are sacrosanct.  Auditors are not infallible and do make mistakes, but as long as there is sufficient evidence to change or remove an observation, the auditor would accept this.  This is very different from manipulating data to justify removing, or downgrading, the criticality of an observation.

Once a QA company or function compromises its integrity, it can never be retrieved.

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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