Data Integrity and Compliance With CGMP

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How does your company handle GXP data?  CGMP violations involving data integrity have been increasing over the last few years.  Data integrity is an important component to ensure safety, efficacy, and quality of drugs.

This guidance document is critical for all pharmaceutical, medical device and biotechnology companies to help establish robust data handling policies and procedures. It clarifies data integrity definitions, discusses when to retain original documents, describes how to handle electronic data, when it is permissible to exclude CGMP data from decision making and much more.

Learn more and download the guidance document here.