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01252 375362

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Data Integrity within your Quality System and Wholesale Business

by | Dec 19, 2014 | Business, Quality Systems

DATA INTEGRITY – is Mickey Mouse filling in your documents?

What is data integrity?

The extent to which all data are complete, consistent and accurate throughout the data lifecycle. From its generation and recording to use, retention, archiving, retrieval and its destruction.

How can this be achieved?

  1. Have an organisational culture which strives due to leadership and risk awareness
  2. Encourage the right behaviours throughout your company from the warehouse operative to the managing director
  3. Keep it simple – can you tick yes to the principles below? If no review your system

– Attributable

– Legible/permanent

– Contemporaneous

– Original

– Accurate

4. Data review and system monitoring

 

If you would like any further information regarding Data Integrity or an Audit and GAP Analysis of your current system, Contact Pharmacy Consulting Limited on 01252 302342

Testimonials

Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it see… Read more
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