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In the past, validating computer software for automated processes has been a cumbersome, paperwork-intensive task with limited practical benefits. Excessive paperwork and inadequate validation methods have often led to inefficiency and ineffectiveness. However, today, the FDA recognizes that embracing digital capabilities enables manufacturers to reduce errors, optimize resources, and enhance...
Companies of all sizes are now investing in product lifecycle management (PLM) software to gain better control of their product development processes and reach their commercialization targets. Yet, industry surveys indicate that some companies struggle to implement PLM successfully.1 Doug Johnston, Solution Architect at Arena, a PTC Business was a recent recipient of the PTC Change Maker award...
Internal quality audits are crucial for ensuring regulatory compliance and identifying operational strengths and weaknesses in product development and manufacturing sectors, especially in regulated industries like aerospace and medical devices. In-house expert Christine Pompa emphasizes strategic planning and empathy during audits while utilizing a quality management system, such as Arena QMS to effectively align teams and assure adherence to various regulations.
