Abstract
Data integrity has recently been in the regulatory agencies limelight. It is primarily due to increased number of inspections findings related to data integrity. Regulatory agencies have published many guidelines for industry to follow starting from 1963. AT that industry was using the completely paper-based system but due to the technology advancement, we are in electronic age. Most of the pharmaceutical industry is operating in the hybrid mode. It is clear that it started with basic regulations, then 21 CFR Part 11 and now ALCOA plus. Regulations from the beginning are stating that there should be a traceability for any action you perform on paper- and electronic-based systems. This article is trying to address some of the issues and how data integrity issues can be corrected by implementation of simple checklists and other measures.
- Received June 2, 2017.
- Accepted November 1, 2017.
- Copyright © 2017, Parenteral Drug Association
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