Quality
6 Must-Haves for a Quality Management System
The U.S. Food and Drug Administration (FDA) expects life sciences companies to build quality into their products. But testing alone won’t ensure product quality. The smartest way to build quality into your products is with an effective, connected quality management system (QMS). Since not every QMS offers the same capabilities and connectivity, companies must make sure the solution they implement includes six core QMS requirements.
1. Simplify Quality Automation
Quality systems are complex, but manageable with a QMS that automates all quality-related tasks such as routing, tracking, escalation, review, and approval of documents and forms. This applies to standard operating procedures (SOPs), training records, electronic production records, and anything else that requires review and approval. An automated QMS keeps you prepared for an audit with the most up-to-date version of each document, fully automated change control, and an electronic signature trail.
2. Connect All Areas of Quality
Connecting different quality processes such as document control, training management, change control, CAPA, quality audit, nonconformance disposition, customer complaints, and other processes is critical in compliance. Consider the example of a defective medical device, in which a new glucose monitor shows erroneous readings during testing. An investigation of this product would cover the entire product life cycle. All updates in the documentation for this product would be managed through the document control process.
3. Provides Robust Analytics and Reporting
In today’s competitive manufacturing environment, organizations must not only ensure product quality, but also have insight into all quality processes. Those in regulated environments, especially, need all the support they can get to see trends and understand quality issues to proactively solve problems. Their ability to adapt to changes and problems in a timely manner can make all the difference between a simple CAPA or a product recall. Even if you’re working with a digital system, Excel data dumps are a fact of life. It doesn’t have to be that way, though. With connected quality data that is always up to date, all the information you need is immediately available to you.
4. Supports Change and Growth
Automating a quality system is a major endeavor in terms of time, effort, and cost. Rather than be forced to revamp their system often, organizations choosing a QMS should take into consideration how the system would support future growth at three individual levels: users (by the dozens, hundreds, or thousands); business units (domestic and/or overseas); and operations (new products and services). The system must be able to adapt to changes in the market and in the regulatory environment.
5. Integrates Training Into Quality Management for Continuous Improvement
CGMP regulations require all those engaged in product manufacturing to have the education, training, and experience necessary to do their jobs properly, including ongoing training in CGMPs. Training is similarly important in the ISO sector: the sixth quality management principle of the ISO 9000 series refers to “continual improvement.” Despite training requirements, many companies fail in this aspect, which is why training is among the top reasons for receiving an FDA Form 483.
6. Makes Continuous Validation a Strategy for Staying Compliant
Companies operating in FDA-regulated industries are required to provide documented evidence that their computer systems consistently produce results meeting predetermined specifications, a practice known as validation. 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. In most cases, validation requires months to complete and produces stacks of paperwork to prove validation occurred. Using a risk-based approach to validation, which is what the FDA itself suggests, lets users assess the risk to their business based on their individual usage of the software. Having a QMS that provides documentation and only doing additional testing for high-risk features, validation can be a matter of hours or even minutes.
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An effective QMS is the foundation of any regulated organization’s compliance efforts. A QMS that has the above features will help companies realize maximum value for years to come.
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