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Ensure Data Integrity and Part 11 Compliance Across Your Entire Enterprise

 

Due to FDA regulations, any system within a Life Sciences organization that captures, stores, modifies, and retrieves electronic data MUST ensure integrity from design to implementation, to data usage.

Life Sciences organizations must comply with FDA regulations when it comes to assuring data integrity, or risk suffering huge yet preventable consequences. The consequences of NOT complying with these regulations are unacceptable in terms of time, money, resources, and opportunity cost.

It is often arduous in practice to ensure data integrity throughout your organization. There are however, basic principles and processes that help companies ensure data integrity and improve organizational compliance including:

  • cGxP Guidelines
  • Employee Training
  • Effective Leadership
  • Software Solutions

In our recent white paper, we cover many of these timely and pressing issues surrounding data integrity within a Life Sciences organization.

Xybion Corporation Â© 2018

We will send the white paper to the above mentioned Email ID.

Download the White Paper

Is Data Integrity An Impossible Task?
 

With our extensive global experience working with companies of all sizes, we offer deep domain knowledge of FDA regulations and have a long track record of helping clients build effective compliance and risk mitigation strategies.

Xybion provides a total compliance and quality management solution for companies operating in heavily regulated industries. As part of this total solution, we offer ComplianceBuilderâ„¢, a unique solution that helps companies ensure they are properly monitoring all files, databases, and equipment in accordance with 21 CFR Part 11 and other regulations.


ComplianceBuilder is a cost-effective solution that provides compliance with minimal system and operator changes.

 

Xybion - Your Expert Partner