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Elements To Consider When Automating QA Processes

Automation - 30 January 2013

Once the time comes for a life sciences organization to automate its QA processes, what should be considered before beginning this initiative?

Identify and prioritize the QA processes that must be automated:

    • 1- CAPA/Change Control;
    • 2- Audit/Complaint/Deviation Report;
    • 3- Etc.

Every organization will have its own priorities with regard to which quality processes need to be automated first. However, for most organizations that are transitioning from a purely paper-based QMS to a fully automated eQMS, the “core complaint” processes are the activities that are most often identified as their priorities. More specifically, CAPA and Change Control are most often identified as the processes that need to be automated first. The next processes that are often addressed are Audit, Complaint and Deviation Report and so on and so forth. A potential mistake that an organization can make when transitioning from a paper-based Quality Management System to Quality Management Software is to attempt to change everything at once. There are significant benefits to approaching this transition in stages; in other words, identify your organizations ‘A’ priorities and implement those in year one and move to the next level priorities in years two and three. An organization will significantly increase its probability for a successful implementation by taking this approach.

The graphic below will help set exceptions for which eQMS functions will require the greatest or least amount of relative effort to convert from “paper to electronic”.