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6 Ways to Ensure Your Quality Management System Meets FDA and ISO Compliance

Ensure QMS system Compliance

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 and continuous compliance.

#1: Automate your quality management system to simplify the compliance environment.

A quality management system (QMS) can be complex and difficult to manage across an entire enterprise, especially in regulated environments where strict adherence to current good manufacturing practices (CGMPs) and other quality requirements or standards are required. This is especially true with a paper-based or partially electronic quality system. Automating such processes with a fully digital QMS can help enhance efficiencies and accelerate product delivery while maintaining compliance.

An optimal QMS solution simplifies the compliance environment, standardizes and streamlines processes, and promotes efficiency throughout the enterprise. It provides a single location for all quality data and documentation, making it easy to maintain and retrieve quality information during inspections and audits. 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 QMS solution for holistic quality management.

In regulated environments, having a fully digitized, integrated quality management system in place helps organizations automate and streamline their processes to improve operational efficiency and overall compliance. An optimal QMS solution provides connectivity in many ways, including:

  • Connecting different quality processes critical to compliance, such as document control, change control, training management, corrective action/preventive action (CAPA), and audit management.
  • Integrating with other core enterprise systems, such as enterprise resource planning (ERP), product life cycle management (PLM), manufacturing execution systems (MES), and laboratory information management systems (LIMS).
  • Connecting different people and departments involved in quality control, even vendors, consultants, and other authorized third parties, regardless of location.

#3: Choose a QMS solution with robust analytics and reporting capabilities.

A quality management system can generate a lot of quality data. To make sense of all this data and to gain greater control of quality operations, organizations need visibility into information, robust analytical tools, and advanced reporting. An optimal QMS solution improves access to data that was previously unstructured and trapped in paper documents and disconnected applications.

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. A robust QMS solution’s interactive business intelligence and data management tools provide complete access to data and allow quality and compliance professionals to analyze insights, draw conclusions about information, and improve decision making.

#4: Choose a flexible, scalable QMS system to support change and growth.

Approximately 74% of quality process end users report that launch delays of products and services are frequently caused by inflexible quality processes, according to Gartner research.1 For life science and other regulated companies, an optimal quality management system offers the flexibility and scalability necessary to adapt to market changes and support growth.

A configurable, cloud-based QMS solution allows companies to automate their quality processes in their core quality areas and then further enhance the system by incorporating additional advanced tools and emerging technologies as the company requires while maintaining the entity's own unique processes. Dynamic workflows and design flexibility help users work smarter. The solution’s architecture is scalable to make adding more users and increasing storage easy as business needs grow or change.

#5: Integrate training into quality management for continuous improvement.

In FDA environments, CGMP requirements demand ongoing training for personnel. Training is similarly important in ISO environments. An important way for organizations to manage training tasks and related compliance requirements is by integrating comprehensive training management into the QMS system.

An optimal QMS solution automates and streamlines training processes to ensure compliance with current quality requirements in a few key ways:

  • Recording and maintaining a detailed status of each employee’s training in one location.
  • Preventing employees from signing off on training tasks until they have completed the training.
  • Keeping employees moving through their training by sequencing training courses.
  • Enhancing the effectiveness of training programs by incorporating helpful learning aids.
  • Giving user access to Shareable Content Object Reference Model (SCORM)-compliant courses.

#6: Make continuous validation a strategy for QMS compliance.

To maintain FDA compliance, regulated companies with an automated QMS solution must validate their software and remain in a constant state of validation. This generally means they must re-validate with every upgrade or system change. The validation process can be time-consuming and costly. An optimal QMS is designed to allow for continuous validation while dramatically reducing the time, effort, and cost involved in the validation process and ensuring quality system compliance.

MasterControl’s patented Validation Excellence Tool (VxT)™ dramatically cuts down on the testing time, eases the overall validation burden, and helps maintain a constant state of validation and QMS compliance. The automated tool is coupled with a proven, risk-based validation approach that focuses on critical business processes and follows the FDA’s recommendation to take the least burdensome approach to software validation.

To learn more about what components of a quality management system will set you up for success, download MasterControl’s QMS Buyer’s Guide.

  1. Reimagining Quality Processes for the Digital Era,” Gartner Quality Research Team, Nov. 1, 2019.


David Butcher has covered business and technology trends in life sciences and industrial manufacturing for more than 15 years. Currently a content marketing specialist at MasterControl, he previously served as editor of Thomas Publishing’s Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.

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