Quality
In regulated environments, such as those under the jurisdiction of the U.S. Food and Drug Administration (FDA) and/or International Organization for Standardization (ISO), quality is included in regulations and standards. So, quality isn’t just good business sense, but also a matter of compliance and requires a good quality management system (QMS).
The FDA states that “quality should be built into the product, and testing alone cannot be relied on to ensure product quality.” The ISO 9000 series of standards also points out the importance of making quality an integral part of a manufacturer’s daily operations. In today’s world, doing this requires automated manufacturing and digital systems
The best way to build quality into a product is with an effective, connected digital QMS. This is the foundation for long-term regulatory compliance and market success. However, not every QMS has the same capabilities and connectivity. A QMS that isn’t connected to other areas of the company and requires using rigid processes with little flexibility slows down quality processes and introduces the possibility of more human error.
Life sciences companies need a QMS that provides functionality across all areas of quality. This includes document control, training management, quality event management (such as corrective action/preventive action [CAPA] management), etc. It also needs to integrate with other systems. The ideal QMS should let you easily configure it to meet your processes, instead of forcing you to change your processes to meet the QMS. A QMS that isn’t flexible will always slow down processes and keep you from making changes to become more efficient. To find that QMS, look for a system that does the following.
Just because a system is automated doesn’t mean it can’t be flexible. Highly configurable systems let you automate which paths a quality event management investigation takes based on the data provided. Due to recent advance s in software validation you can make these changes quickly and then validate them to ensure you’re operating in a validation state.
With a connected QMS, users can enter a quality event, investigate it, determine corrective action, approve changes to or new documents, and send out training automatically all in the QMS. This makes it very easy to show your process during an audit and to quickly pull all documentation related to the original issue and how it was resolved.
An advanced QMS offers features to track, trend, and report on the data within the QMS. You can use the out-of-the-box reports in the QMS, but also easily create your own with intuitive tools. The level of detail is flexible, allowing you to see a broad overview or drill down into the details of the data. Forward-thinking vendors will offer predictive quality analytics. An example of this is to tell you if an employee is going to be overdue on training. Predictive quality analytics and closed-loop quality ultimately improve your bottom line.
Flexibility is equally as important. A difficult part of user adoption is when you need users to change how they do things to fit the system. That’s why it’s easier to find a QMS that can be changed to fit your current processes. This can be done through custom code, but that makes it difficult to make any changes without heavy services fees. A no-code QMS that can be configured to match your processes lets you design your own workflows. Then you can quickly make changes whenever needed without compromising software validation.
Some of these documents are training records. Despite training requirements, many companies fail at keeping employees trained and keeping track of the records. Not surprisingly, training is among the top reasons for receiving an FDA Form 483. There are two reasons for this. One is that a lack of efficiency, visibility, and connectedness means employees can’t perform according to industry standards. The second is that, even when employees are trained, it is difficult to find the paperwork that proves they were trained. A training management system alone can’t solve these problems. But with a QMS that has automated assignments, monitoring, and verifying of training tasks, you can ensure training happens and that you can easily find the records needed during an audit.
MasterControl is a trailblazer in simplifying and expediting software validation for our customers. The patented Validation Excellence Tool (VxT)™ uses a risk-based approach to validate, which is what the FDA itself suggests. VxT lets users assess the risk to their business based on how they use the software. By relying on MasterControl documentation and only doing additional testing for high-risk features, validation can be done in hours or even minutes . With more flexible, configurable software, validation needs to continue to evolve. MasterControl is again innovating with the patented Validation on Demand (VoD )™. VoD lets users perform next-generation, automated validation testing targeted to their unique use cases and workflows.
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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