Der Artikel wurde erfolgreich hinzugefügt.

Data Integrity in the EU

Enter the first customer review for this item

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 pages

ISBN: 978-3-958070912

1st edition 2018

Delivery immediately after receipt of payment

€345.00 net

€410.55 * prices incl. VAT

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.

Available downloads:

Reading Sample - Data Integrity in the EU


Customer reviews will be activated after verification.
Write a customer review

Please enter these characters in the following text field.

The fields marked with * are required.

  • 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.

Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.
  • Top Ten Data Integrity Traps
    Download

    How to Find and Fix Problems

    A FDAnews publication

    €147.50 net

  • GMP LOGFILE

    Newsletter

    With this GMP newsletter you will be regularly informed on the latest developments in GMP.

    Sign up