White Paper — Sponsored Content

Data Integrity: How to Prevent a Significant Source of 483 Warning Letters in Drugs, Devices, and Biologics

ICQ consultants

5 Practical Ways to Proactively Avoid Data Integrity Issues for Improved Quality

Pharmaceutical and biotechnology companies are no strangers to FDA 483 warning letters. In fact, the categories of Devices and Drugs accounted for the second- and third-most 483 warnings issued by the FDA in 2019. Although not the top source of 483s, issues related to data integrity were responsible for a significant portion of the warning letters in these categories as well as in the growing field of Biologics.

Companies that can identify, remediate, and prevent data integrity issues will have a distinct advantage over those that continue to let data and procedures go unchecked. Download this white paper to learn five ways to address data integrity and process issues to minimize 483 warning letters.

For more information, visit ICQconsultants.com.

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