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Risk Management Is More Than a Spreadsheet In a previous article, we discussed several causes that lead to product malfunctions and how to mitigate them. In this article, we will look at how a change from a document-driven risk management approach to a data-driven risk management approach can help mitigate product failure. Mitigating risk …
Laying the Groundwork for an AI Breakthrough Big data and artificial intelligence (AI) have been billed as “the next big thing” for more than a decade. Theoretically, these approaches present R&D groups in the medical device industry with enormous prospects. Realistically, many organizations have trouble realizing their full potential. Some businesses have resisted or …
Contamination Control: Practical Steps to Compliance with EU GMP Annex 1 In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new provisions must be fulfilled by August 2023. The updated requirements, designed to protect …
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