Data Integrity in the EU: Requirements for Quality Management Systems

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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.

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PDF Edition


Available Format

PDF Edition — $397

Who Will Benefit

  • Quality managers
  • Lab supervisors
  • Regulatory affairs/compliance department

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