Data Integrity in the EU Requirements for Quality Management Systems
The FDA is not the only regulator focusing on data integrity.
If you do business in the U.S. and European countries, you need to know the requirements for quality management systems from all the authorities.
The European Medicines Agency (EMA) — the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) — and the World Health Organization (WHO) — all have data integrity guidelines. And, their regulations don’t always agree.
You’ll understand all the requirements with Data Integrity in the EU: Requirements for Quality Management Systems. This report details the ins and outs of all three documents and explains how the FDA regulations fit in.
You will learn:
The five principles of data integrity
Differences between EU and UK definitions of data integrity and raw data
The differences between raw data and metadata
Ensuring the integrity of original paper-based records vs. electronic records
Systems to monitor data integrity
Laboratory handling and testing of samples
Storage and archiving of records
Data integrity during process development and validation
The report also includes the texts for:
EMA’s question-and-answer document on data integrity
MHRA’s GXP data integrity guidance
WHO’s Annex 5: Guidance on Good Data and Record Management Practices.
Order your copy of Data Integrity in the EU and avoid data problems and breaches that can damage your drug’s success.
Order Your Copy Today
PDF Edition — $129
Who Will Benefit
Regulatory affairs/compliance department
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.