Quality assurance tools help companies manage quality processes. Digital tools streamline deviations, corrective and preventive actions (CAPAs), and other processes. Digital tools built on the same platform provide further visibility into a company’s quality assurance. This is ideal for maintaining compliance and resolving issues before they escalate.
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Digital quality assurance tools are the best way to implement a closed-loop quality management system (QMS). The tools are interconnected, so any quality event can be tracked through to resolution. Automated routing prevents bottlenecks, and the digital system provides an automatic audit trail.
The U.S. Food and Drug Administration (FDA) and other regulatory bodies set current good manufacturing practices (CGMPs) for pharmaceutical manufacturing. Using quality assurance tools makes quality part of the product development process instead of an afterthought. Pharmaceutical companies can use these tools to prevent mistakes before they happen and effectively resolve quality events.
Medical device manufacturers must comply with 21 CFR Part 820, which outlines current good manufacturing practices (CGMPs) for medical devices. Quality assurance tools keep manufacturers in compliance with part 820 and guarantee safety and quality in finished products.
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