Der Artikel wurde erfolgreich hinzugefügt.

Data Integrity in the EU

Geben Sie die erste Bewertung für diesen Artikel ab

Nowadays all regulatory authorities focus on data integrity and have their own data integrity guidelines - however, their regulations don’t always agree.
With this e-book 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

111 Seiten

ISBN: 978-3-958070912

1st edition 2018

Lieferung sofort nach Zahlungseingang

345,00 € netto

X

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.

Weitere Informationen

Reading Sample - Data Integrity in the EU


Bewertungen können anonym erfolgen und werden nach Überprüfung in unserem Webshop veröffentlicht.
Bewertung schreiben

Bitte geben Sie die Zeichenfolge in das nachfolgende Textfeld ein.

Die mit einem * markierten Felder sind Pflichtfelder.

  • laboratory
  • quality management
  • documentation

Technical Requirements

This file is in PDF format!
Filesize: 1,6 MB

To view PDF files, we recommend using the Adobe Reader.

https://get.adobe.com/de/reader/

The e-book is password protected to prevent copying and modification of content.

Please note the following procedure guidelines:

For payment by invoice:

  • You will receive an advance invoice by e-mail within 1-2 working days. You payment is required for the download.
  • After receipt of payment you will receive an e-mail with the download information.

When paying by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • Your invoice will be sent in a separate e-mail within 1-2 working days.
  • Top Ten Data Integrity Traps
    Download

    How to Find and Fix Problems

    A FDAnews publication

    147,50 € netto

  • Zum Vorteilspreis: Unsere Bestseller zum Thema Datenintegrität als...

    115,00 € netto

  • GMP-Regelwerke zur Datenintegrität (E-Book)
    Download
    • WHO: Leitlinie zur Guten Praxis für das Daten- und Aufzeichnungsmanagement
    • EMA:...

    25,90 € netto

  • SOP 400 Datenintegrität und Data Governance
    Download

    Möchten Sie stets die Herrschaft über GxP-relevante Daten haben und somit ihre...

    219,00 € netto

  • 390,00 € netto

    GMP-LOGFILE

    Newsletter

    Lesen Sie GMP-News und informative Beiträge zum Thema GMP in unseren kostenlosen GMP Newsletter "LOGFILE".

    Anmelden