Data Integrity in the EU

Excerpt from the GMP Compliance Adviser

Nowadays all regulatory authorities focus on data integrity. 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.