The MHRA’s GXP data integrity guide was published in March 2018. ‘GXP’ refers to the various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority (GLPMA). These are
- Good Clinical Practice,
- Good Distribution Practice,
- Good Laboratory Practice,
- Good Manufacturing Practice and
- Good Pharmacovigilance Practice.
As can be seen below, from an extract of the guide, section 3.1 states a clear expectation that ‘the organisational culture’ should ensure data is complete, consistent and accurate in all of it’s forms.
The guide also refers to the acronym ALCOA as the “attributes of data quality that are suitable for regulatory purposes”.
Do the people in your team understand the principles espoused by ALCOA and their role in making sure that your data quality is ‘suitable for regulatory purposes‘?
Have you met this challenge? Or if not, will your organisation be one of the many facing compliance issues on your next MHRA inspection?
We can help. Our 20-minute online course on Data Integrity can help you to meet this challenge. It is affordable for every member of your team and covers these topics:
- 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
- Positive Quality Culture
After successful completion of the course, a certificate with our logo and the RSC Approved Training logo is available for download by the learner and/or your team administrator.
Find out more by clicking on any of the links in this article or here.
The MHRA’s GXP data integrity guide can be read in full by selecting the text in blue.
For anyone needing a more detailed review of this important topic we also offer a one-day course.
Find out about our course ranges