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| By following six steps, regulated companies are better positioned to adopt and validate eQMS software with ease. |
by Kevin Ballard, Director of Software Validation, MasterControl
Validation is one of the most time-consuming and resource-intensive activities when implementing eQMS software in a regulated environment, often delaying implementation and an organization’s ability to go live with new software.
If your company is regulated by the Food and Drug Administration (FDA), you are required to validate your electronic systems to comply with 21 CFR Part 11 and 21 CFR 820, among other regulations. While the FDA requires validation, it does not specify how to validate. Rather, the agency wants evidence that you’ve documented how you intend to validate, and prove that you’ve done it the way you said you were going to. The goal is to ensure the software will work as expected for your use cases, and to make sure that any invalidated or altered records are easily identifiable.
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