Abstract
The purpose of this document is to describe behaviors, including the elements and controls, to ensure the integrity of GxP data in pharmaceutical manufacturing operations. Fundamental concepts such as ALCOA (attributable, legible, contemporaneous, original, and accurate) and the prevent/detect/respond approach to a data integrity program are defined and discussed. This paper was developed through the PDA Data Integrity Task Force and reviewed and approved by the PDA Regulatory and Quality Advisory Board as well as the PDA Board of Directors. Data integrity is a significant component of a company's Quality System, providing foundational assurance of the data a company uses to operate in compliance with regulatory requirements and to demonstrate its products are safe and effective for their intended use. Through data integrity the company recognizes its responsibility to prove the origin, transmission, and content of the company's data and that data is what it is purported to be. To holistically address Data Integrity, the Parenteral Drug Association (PDA) is developing a set of tools in the form of PDA Technical Reports, PDA Training, Data Integrity Workshops, and Points to Consider documents that can be used by industry to address this serious issue. This document serves as an introduction to that suite of tools to follow
- Received July 1, 2016.
- Accepted July 4, 2016.
- Copyright © 2016, Parenteral Drug Association
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