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A Summary of the New MHRA ‘GXP’ Data Integrity Guidance and Definitions – March 2018

For over 20 years, there have been Health Authority regulations governing the use of Electronic Records and Electronic Signatures (eReS) for GxP purposes. 406 more words


Data Integrity Thoughts

At the MHRA Blog, a GDP Inspector has posted some thoughts on Data Integrity. As always, it is valuable to read what an agency, or a representative, of an agency in this case, is thinking. 180 more words

Quality Intelligence

Data Integrity in the quality system

Data integrity has been, for the last few years, one of the hot topics of regulatory agency inspections for the last few years, one that it has often been noticed seems to be, at times, a popular umbrella for a wide variety of related topics (that usually have a variety of root causes). 343 more words

Quality Intelligence


Increased administrative examination of information trustworthiness features the requirement for exhaustive procedural audits and techniques for overseeing mission-basic data.

The administrative prerequisite for information genuinely isn’t new and was expressed in 21 Code of Federal Regulation (CFR), Part 11 out of 1997 (1) 2,508 more words


Exploiting drug redeployment for modern-day drug discovery

By Sabrina Hossain, University of Birmingham

The progression of drug discovery and development over the last 50 years has been rather exciting for scientists and the community to follow. 964 more words

Front Page

Letter to Government: Mesh Health Scandal

***For the attention of Lord O’Shaughnessy, Lord Hunt, Baroness McIntosh, Baroness Jolly, Lord Patel and Baroness Tonge ***
Dear Lords and Ladies,
I am grateful to you all for your contributions to the review of the safety of pelvic mesh implants in the House of Lords last week, on Tuesday 6th February 2018. 1,465 more words

Mesh Activism