Smart manufacturing magazine has published an article which was written by Adion Systems co-founder and President of ProShop USA, Paul Van Metre. The article summarizes the importance of record keeping in the industry of medical devices. Van Metre goes on to state that the regulations in this industry “pose a real logistical challenge to medical device makers trying to adopt industry 4.0 and move to a fully digital environment”. CFR820: Subpart D 820.40(b) dictates that: “Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective”. Going forward in the article, Van Metre explores the idea of moving from a traditional paper-based quality system to a paperless ERP system with these requirements in mind. He mentions how manufacturing engineers would be able to focus most of their time on process improvements, instead of becoming paper pushers with the help of this type of paperless ERP system. He ends the article by saying “The pace of innovation and process improvements can accelerate exponentially. There are specialized medical QMS software programs that already do this, but they are generally isolated silos of information, detached from the ERP and MES systems that are essential to daily operation of a manufacturer. By combining all of these essential functions, manufacturing companies can unleash their true potential.”
Read the full article here
Read the article on advancedmanufacturing.org here
About Smart Manufacturing Magazine:
SME’s Manufacturing Engineering has been covering smart manufacturing technologies from the beginning. But the growing need for education, alongside increased offerings and adoption, has provided us with the opportunity to lead the discussion on the future of making things.
Smart Manufacturing is the leading business-to-business magazine that focuses on advanced manufacturing technologies and tools that are driven or enhanced by integrated information technology (IT).
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