Duration
1 Hour
Data Integrity
It is important to consider how we generate, maintain and store records, particularly for paper based and electronic mediums, both now and in the future. (See Chapter 4 of the EU GDP Guidelines).
The Data Integrity course shows you how and why you must ensure that any records or data generated are kept in a suitable and readable format, with records and data remaining secure, accessible and unaltered, until their expiry date.
Maintaining Data Integrity forms part of your Quality Management System. Any omissions, oversights, lost or incorrect record keeping will be picked up by inspectors and will count against you. If the issue is serious enough, temporary suspensions can be incurred in the event of a serious deviation from procedure.
The learning objectives of our Data Integrity course are:
- To know and understand what Data Integrity is and it’s importance in GDP workplaces.
- To understand the ALCOA principle (including ALCOA+), and how it should be applied.
- Understand the compliance requirements of data storage in line with EU GDP Guidelines 2013/C 343/01 and MHRA HMR2012.
You will also learn:
- What Meta-data is and why it is so important.
- How to develop a quality culture in your workplace.
- How to apply Data Integrity due-diligence in your day to day activities.
Click the button below for supporting documentation about GDP if you wish to continue your learning journey.
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Help and Support
Ratings and Reviews
Ernest Opoku-Acheampong
Great Information and reliable
sgarcha@hotmail.co.uk
provided the necessary information, brief but comprehensive.
joanne@priorypharma.co.uk
Great learning tool that can be used at your own speed to fit around work commitments and home if necessary
Jeanee York
I like the pre-test to highlight strengths and weakness of understanding. Then the detailed information regarding the course presented immediately to clarify your learning with the opportunity of re-taking the test to check improvements.
I liked the training format. It was easy to follow yet contained a lot of important information.