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Feb 19, 2015

6 Ways to Ensure Your QMS Meets FDA and ISO Compliance


by David R. Butcher, Marketing Communications, MasterControl

An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.

Following these six guidelines will help FDA-regulated and ISO-certified organizations optimize their QMS to ensure high-quality products/services and continuous compliance:

This article is related to the Whitepaper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance. To get the full details, please download your free copy


1) Automate Your System to Simplify the Compliance Environment. Quality systems are complex and can be difficult to manage across an entire enterprise, especially in regulated environments where strict adherence to quality standards is required. This is especially true when quality systems are paper-based or only partially electronic. Automating such processes with a QMS can help enhance efficiencies and accelerate product delivery while maintaining compliance. By simplifying and streamlining processes through automation, organizations can significantly reduce document approval cycle times from months or weeks to days.

2) Choose a Connected Solution for Holistic Quality Management. In regulated environments, having a fully integrated QMS in place helps organizations automate and streamline their processes to improve operational efficiency and overall compliance. An optimal quality management suite provides connectivity in many ways, including: connecting different quality processes critical to compliance; integrating with existing electronic repositories; and connecting different departments and people involved in quality control, regardless of location. Without an integrated QMS, it isn’t uncommon to find disconnected quality tasks, information and people.

3) Choose a Solution with Robust Analytics and Reporting Capability. A QMS can generate a lot of quality data from various groups and cross-functional teams. To make sense of the data flood and to gain greater control of quality operations, organizations need visibility into information. To ensure greater visibility, companies must leverage QMS data to perform analytics and provide advanced reporting, helping to draw conclusions about information and improve decision making. A QMS has little value if the system does not enable users to visualize, monitor and report on data collected, and then use that data to make informed decisions.

4) Choose a Flexible and Scalable System to Support Change and Growth. For life science and other regulated companies, a QMS must offer sufficient flexibility and scalability for quality management across the entire organization – including different locations, multiple business units and different departments – whether a small start-up, a midsize company beyond the start-up phase or a large corporation. Its architecture should be scalable to make adding more users and increasing storage easy as business needs grow or change, but also flexible to adapt to changes in the market while maintaining the entity’s own unique processes.

5) Integrate Training into Quality Management for Continuous Improvement. In FDA environments, CGMP requirements demand ongoing training for personnel, and in ISO environments, continuous improvement is similarly important. In constantly developing markets, regulated companies’ personnel must always be learning about industry issues, regulations and the quality management solutions that ensure compliance. An optimal QMS automates and streamlines training processes to ensure that employees always know how to complete their tasks and, ultimately, comply with current quality standards.

6) Make Continuous Validation a Strategy for Staying Compliant. To maintain FDA compliance, regulated companies with an automated QMS solutions must have their software validated. The FDA also requires companies to be in a constant state of validation, which generally means they must re-validate every time they upgrade or change their systems. The validation process can require a significant amount of time and expertise. An optimal QMS is designed to allow for continuous validation while dramatically reducing the time, effort and cost involved in the validation process and allaying fears of non-compliance.

This overview serves as a foundation for optimizing a QMS that ensures continuous compliance and, ultimately, spares unnecessary costs of poor quality. For a more in-depth look at how to optimize your QMS, check out MasterControl’s free white paper, Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance.


David Butcher has been writing about business and technology trends in the industrial B2B space for more than a decade. Currently a marketing communications specialist at MasterControl, he previously served as editor of ThomasNet News’ Industry Market Trends newsletter and blog and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions magazine. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.






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