Aaron HoareMedical device design controls are a set of policies and practices intended to ensure consistent translation of input requirements into a physical product that meets those requirements.Good design controls are important to:Reduce product risks Demonstrate your product is fit for purpose Align your organizationISO 13485:2016 sets out a series of requirements for design controls. So how can you actually apply, manage and use our software to ensure you are compliant with ISO 13485 design control requirements?Each of the sub-clauses in 7.3 require documented SOPs (Standard Operating Procedures). Our software takes this one step further – it enables you to enforce each of the procedures, making quality b

 Aaron HoareEffective CAPA management is essential in the medical device industry, with corrective and preventive action a core pillar of ISO 13485. ISO 13485 is the international standard for demonstrating a commitment to quality, and the importance of CAPA is clear throughout the standard – not to mention it having two dedicated clauses, 8.5.2 and 8.5.3, for corrective and preventive action respectively.So, in simplest terms: CAPA management for ISO 13485 is essential, and by extension is important for all types of medical device organization. Meeting the demands of ISO 13485 would be impossible without sound CAPA management.Without being firmly in control of your corrective and preventive actions, you open up your medical device quality management system, and your entire organization, to intense scrutiny and avoidable risk. Not to mention, opening up pa

 Antiksha JoshiThe pharmaceutical and wider life science industry is slowly but surely moving toward Industry 4.0. This is evidenced by the regular entry of new and improved equipment, monitoring systems, and electronic quality management systems into the market, as well as the increased number of regulatory publications on the same.Organizations are increasingly adopting and implementing software-based and automated solutions for many of their quality systems as well as manufacturing processes. The most common, and often the first system any organization implements, is an electronic Quality Management System (eQMS).Choosing and implementing an eQMSWhen choosing and implementing an eQMS, the organization's sole purpose is to reduce human errors and improve efficiency. Once an eQMS is implemented and in use, it is often found that problems have not

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  Aaron HoareIn the realm of quality management systems (QMS), managing Corrective and Preventive Actions (CAPAs) in manufacturing takes center stage. A strong grip on your CAPAs not only shields your QMS and organization from serious examination, but it also acts as the cornerstone of continuous quality improvement.Key advantages of strong manufacturing CAPA processes include reduced defects, reworks, and out-of-specs; easier adherence to quality standards and regulatory demands; improved efficiency across your organization; better safety standards for end-users; significant reduction in costs.Put simply, CAPA management in manufacturing ensures a process for getting things right first time and, crucially, making sure things stay that way. This is a must for any quality team.If your current CAPA system seems wanting, continue reading this introduct

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Does anyone have any examples of how they are using an eQMS to support their Business Continuity Management processes?

Does anyone have a good example of MoC process they would recommend for an eQMS? Based on Demming?