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Data Integrity in the EU

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Nowadays all regulatory authorities focus on data integrity and have their own data integrity guidelines - however, their regulations don’t always agree.
With this pdf download you will understand all the requirements! This report details the ins and outs of all three documents of EMA, MHRA and WHO and explains how the FDA regulations fit in.

e-book / PDF-Download

111 Seiten

ISBN: 978-3-958070912

1st edition 2018

Lieferung sofort nach Zahlungseingang

345,00 € netto

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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.

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Reading Sample - Data Integrity in the EU


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