When designing a manufacturing process within the Life Sciences/Biotech/Pharmaceutical industries, you must adhere to the FDA's expectations around Data Integrity. But what does Data Integrity mean for your manufacturing process within the guardrails set by the FDA and cGMP (current Good Manufacturing Practice)? Skellig Automation's Bonnie Gauss discusses the basics of the FDA's expectations around Data Integrity as detailed in the guidance released in 2018.
Whether your process is built within the traditional automation stack or Industry 4.0 architecture, building in Data Integrity from the beginning will prevent many common issues at manufacturing sites.
Skellig Automation is a systems integrator within the Life Sciences that focuses on educating and innovating within the industry. If you'd like to learn more about Data Integrity, Industry 4.0, and other automation topics, be sure to check us out at: [ Ссылка ]
Link to the FDA's guidance on Data Integrity and Compliance: [ Ссылка ]
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