The Data Integrity Working Group has added four additional resources (links below) to the Data Integrity Library. We welcome you to share these resources with colleagues and industry members. If you would like to see other resources added to this library please feel free to email suggestions to email@example.com.
As always we sincerely thank our working groups, members and observers for all their hard work and dedication in support, protection and promotion of patient safety.
- Empower Software Audit Trails and Logs: A guide to the different locations of audit trails in Empower and what information they provide to Reviewers – Whitepaper
- MHRA GMP Inspectorate Blog: MHRA Data Integrity Guidance: 18 months on (21 July 2016)
- MHRA GMP Inspection Deficiency Data Trend 2015 (see slides 63 -66)
- Notice of Concern, Micro Labs Limited, 2014