• Available Formats
    • Availability
    • Priced From ( in USD )
    • Secure PDF

      Secure PDF Files

      Secure PDF files include digital rights management (DRM) software. DRM is included at the request of the publisher, as it helps them protect their copyright by restricting file sharing. In order to read a Secure PDF, you will need to install the FileOpen Plug-In on your computer. The FileOpen Plug-In works with Adobe Reader and other viewers. Visit FileOpen to see the full list.

        What you can do with a Secure PDF:
      • Print
      • Search
      • Highlight
      • Bookmark
      Please note that some publishers - including BOMA, IADC and NRC - do not allow printing of their documents.

    • Immediate download
    • $350.00
    • Add to Cart

About This Item


Full Description

The ISPE GAMP® RDI Good Practice Guide: Data Integrity ? Key Concepts provides detailed practical guidance to support data integrity within a regulated organization.

In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which a regulatory decision is based.

Additionally, the implementation of behavioral, procedural, and technical solutions to meet regulatory requirements throughout the business process proves to be challenging for organizations that do not have expertise in incorporating data integrity into their daily activities.

This Guide integrates tools such as Cultural Excellence and critical thinking skills into data integrity practices to aid companies in meeting regulatory requirements and expectations. Numerous examples of good data integrity practices along with ways to identify risks and detect issues are included to assist organizations in developing or raising their data integrity awareness.