White Papers

Debunking 5 Common Assumptions About Quality in Business and Life in General

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White Paper 6 Debunking 5 Common Assumptions About Quality in Business and Life in General Conclusion My point here is to show you how simple and pragmatic quality management is. Quality is what we seek in our personal lives, but especially in the drugs, medical devices, medical therapies, and consumer products and services we need. If you are a quality professional working for an organization still using a paper-based or hybrid QMS, then you are in a better position to appreciate the need for a robust system that will facilitate quality and compliance for you and your colleagues. I imagine you would hesitate to ever buy a product or service from an organization without effective QMS in place. If you need to convince your organization about the necessity to switch to a fully automatic and integrated QMS, you can start by debunking the common but false assumptions we discussed in this white paper. About the Author Paul Sanderson is the head of MasterControl's Solutions Consultants Group. He has spent the last decade helping almost 200 regulated companies choose the right eQMS based on their unique needs and implement it successfully. He has 12 years of enterprise software experience in the life science space. References (1) Warning letter issued to Horizon Pharmaceuticals on Dec. 23, 2016. From the FDA website: https://www.fda.gov/ICECI/EnforcementActions/ WarningLetters/2016/ucm536715.htm (2) Warning letter issued to AG Industries LLC on June 12, 2015. From the FDA website: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ ucm451494.htm About MasterControl MasterControl Inc. creates software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl's integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and postmarket surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use. For more information, visit www.mastercontrol.com. © 2019 MasterControl Inc. All rights reserved. WPXXXXUSENLT-04/19

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