Ensure your team understand the importance of Data Integrity

NOW AVAILABLE - A 20-minute online Data Integrity training course

Now Available – online Data Integrity training for your team

Our 20-minute online Data Integrity training course will ensure your entire team understand the importance of Data Integrity and their role in meeting the expectations of EU Inspectors (such as the UK’s MHRA) and the FDA.

The careful and secure control of data and records is a hot topic at regulatory inspections right now. One reason for this is due to the increased use of computer systems to hold data in one form or another. That said – data integrity is not just about computerised records. Most of all it is about keeping all records, including paper-based records, safe and secure, accessible and free from damage, alteration and deterioration.

It is therefore essential that your team have the correct understanding of what is required of them. Consequently, this online data integrity training course covers the background to Data Integrity, why it is important and how its requirements affect both paper-based and computer-based systems. This 20-minute course will give you and your team a clear understanding of their role in meeting the expectations of EU Inspectors (such as the UK’s MHRA) and the FDA.

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Alternatively to try a free Taster course subscribe by clicking on the link in blue in this sentence.

The benefits of this course:

Accessed over the internet using desktop computers, laptops, tablets, and smartphones
Or available for access via your own internal systems
Aimed at new starters, existing staff and as part of ongoing Data Integrity training
Authored by specialists in the field of Data Integrity who can provide you with additional implementation support, if required
The course provides an overview of DI threats and issued posed within paper, electronic and hybrid systems
It delivers a consistent message to facilitate building a positive Data Integrity culture
At the end of the course assessment ‘quiz questions’ evaluate the learner’s knowledge
Upon successful completion, a certificate is available for download by the trainee and/or the team administrators
It’s simple, flexible and very cost effective

Available online now

The course is available online using our cloud-based services or the course materials can be purchased for use on your own internal systems.

The topics covered are:

What is Data Integrity?
Why it is important
The ALCOA principles, for: Paper-based, computer-based and hybrid systems
Application of the ALCOA Principles
The importance of metadata
The importance of a positive quality culture
Quiz-based Assessment

At the end of the online data integrity training course, there is a series of randomly selected assessment quiz questions. An 80% pass mark is expected to successfully complete the course and following successful completion of the course, a certificate is available for download by the learner and/or their team administrator.

Click here for full details.

To try a free Taster course subscribe by clicking on the link in blue in this sentence.

We offer you a total solution

Inspired Pharma also offers online GMP (click here for details) and GDP courses (click here for details) and consequently this course can be combined with these programmes to meet all of your compliance and refresher training needs.

In addition, there is a much more in-depth one-day public course on Data Integrity. Attend this course and you will possess the understanding required to enable you to implement the required the Data Integrity governance systems, methodologies and programmes within your organisation – click here for details.

And if you would like us to assist your organisation to review and implement your Data Integrity governance systems and methodologies we can provide the necessary expertise in partnership with Clarity Compliance Solutions, who we collaborate with, in this specialist area.

Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.

Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.

While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.

About the author

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

Training courses on Annex 1

There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.

More details