FDA to Issue New Guidance on QMS Validation: 4 Major Changes
Are you having difficulty validating a quality management system (QMS)?
As you know, validation provides a level of confidence in the software's ability to perform according to its intended use. In fact, the U.S. Food and Drug Administration (FDA) requires software validation to demonstrate that the software meets expectations. However, the FDA's guidance on QMS validation will soon change, requiring organizations to make a major pivot.
Is your life science organization prepared?
FDA Guidance on QMS Validation: 4 Major Changes
So, what major changes can we expect for QMS validation?
As an industry-leading QMS provider, we should also let you that our software comes with concierge onboarding and a "validation pack." The purpose of the validation pack is to describe the strategy that will be taken to ensure that our product is fully validated in accordance with all applicable laws, regulations, and requirements governing your use case. Additionally, this validation pack will be updated over time.
With all this in mind, here is a list of the most significant QMS validation changes found in the new FDA guidance.
1. Increased Focus on Computer System Validation
Computer system validation (CSV) is the process of achieving and maintaining compliance with relevant GxP regulations defined by the predicate rule.
Fitness for intended use is achieved by adopting the principals, approaches, and life cycle activities. This validation methodology determines the framework to follow in developing validation plans and reports and applying appropriate controls throughout the life cycle of the system.
Previously, organizations were spending up to two times the cost of software on validation. Interestingly, this compliance-centric approach has resulted in significant quality issues. As a result, the FDA will likely continue to encourage the use of technology and automation to streamline processes and reduce risk.
2. Increased Focus on Critical Thinking and Software Assurance
We can anticipate an increased focus on critical thinking and software assurance as we move further into the future.
To this end, you can begin applying critical thinking by using a risk-based approach to assess the system's features, focusing on the direct impact to patient safety and device quality. By applying this risk-based methodology, you will need to assess what happens in the event there is a system failure.
3. Increased Focus on the Supplier Management Relationship
Given that you will be relying on the supplier's quality system to support your software's compliance activities, more scrutiny on vendor quality assurance is almost guaranteed.
As such, effective quality assurance and management should incorporate a collaborative combination of process and product audits.
The sooner you identify and correct supplier quality issues and non-conformances, the sooner you'll be able to activate on corrective policies and procedures.
RELATED: What is eQMS Software Validation?
4. Recognize Computer System Validation Isn't a Paper Exercise
Old-school validation requires mountains of documentation to assure the system's suitability for the intended use. That being the case, it may take a shift in your quality assurance team's thinking here to understand the change in approach.
Unfortunately, just executing test scripts may not uncover system issues. For the best results, users must "play" inside the system. This unscripted test approach is much better in uncovering bugs, quirks, or failures inside the system.
Streamline Software Validation With Qualio
Qualio is the first cloud electronic quality management system (eQMS) purpose-built for the entire life science ecosystem.
With Qualio, you can easily unite your teams, processes, and data so you can get your products to market quickly. The platform enables you to take the pain out of quality management, regulatory compliance, and preventative actions—and focus more on what matters most to your organization.
Qualio offers an intuitive user experience and simple implementation with a design that's built to scale with rapid-growth companies. Our eQMS is centered around quality document management with features for global collaboration and built-in features to create documents such as policies, SOPs, and other required documentation. We offer the right balance of flexibility and control with workflow tools, document versioning, customized notifications, and best-in-class training and support to help you get up and running as quickly and smoothly as possible. After successful validation, customer success teams are available to train and orient your organization toward sustained QMS implementation and management.
As a critical next step in your quality management journey, we recommend downloading our free guide: 7 Ways to Improve Quality in Medical Device Product Development. Check it out to learn how to leverage medical device quality as a competitive advantage.