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Digitization for Data Integrity and Regulatory Compliance

Article

Last Updated: January 16, 2023

Written by

Bob McDowall, PhD

Digitization for Data Integrity and Regulatory Compliance content piece image

To ensure data integrity and regulatory compliance, analytical procedures involving observation must change from recording observations on paper to direct data acquisition by informatics applications.

This article will explore how the move to digitize laboratory processes promises to make data integrity and compliance, an essential goal for regulated laboratories, an easier task.

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Meet the Author

Bob McDowall, PhD

Director

Bob is an analytical chemist with over 50 years’ experience, including 15 years working in the pharmaceutical industry and over 30 years working for the industry as a consultant. Bob has been involved with process redesign, specifying and implementing laboratory informatics solutions for over 40 years and has nearly 35 years’ experience of computerized system validation in regulated GXP environments. Bob is also a trained auditor. He has run training courses on computerized system validation, digitalization, LIMS, instrument qualification, data integrity and auditing since 1988.

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