GxP Lifeline Feature Article

Six Ways to Optimize Your Quality Management System to Ensure FDA and ISO Compliance

MasterControl software can optimize your Quality Management System to help ensure FDA and ISO compliance.

An optimal quality management system is the foundation for long-term regulatory compliance and enduring market success. Without a solid quality infrastructure, your organization is not prepared to face the challenges of ensuring continuous regulatory compliance. The following suggestions can help optimize your quality management system to ensure high-quality products/services and continuous compliance.

(1) Automate Your System
Many companies in the FDA and ISO sectors continue to rely on paper-based or hybrid (partially electronic) quality management systems. Unfortunately, such systems are inherently inefficient and error prone. They lack a secure, centralized document repository for organizing documents and providing instant access to the most up-to-date product design and quality information. In contrast, a fully automated system that provides a secure, centralized document repository facilitates access to the most current version of all documents.  This is a minimum requirement of an efficient system: it sets the stage for the implementation of automated, connected processes and workflows, which greatly enhance a manufacturer’s ability to implement a quality management system for providing continuous regulatory compliance.

(2) Choose a Solution that Provides Connected Processes
A quality management system can be effective only if it involves connected processes. There must be the ability to launch a CAPA from anywhere (during the manufacturing process, from a customer complaint, as the result of an audit finding) and to marshal the expertise of whatever departments are necessary during the investigation process.  Obviously, Quality and Manufacturing are going to be involved in a CAPA investigation, but other departments, such as R&D, Regulatory, and Sales and Marketing, may also need to be involved. Transparent workflows, one of the many benefits that an automated system can provide, greatly facilitate the ability to secure the involvement of the appropriate team(s). Once the cause of the situation that launched the CAPA has been determined, the ability to make the change(s) necessary to correct the problem is facilitated through a connected, automated Change Control management process.  This greatly enhances quality by ensuring that, once the change is approved, every product containing the product as a subcomponent also gets changed. Likewise, the ability to automate and connect Training Management ensures that, if there's any change in a document linked to a required course because of a revised SOP or policy, all affected trainees immediately receive new training tasks. With a web-based platform, outside departments and authorized users (including vendors, consultants, etc.) who are involved with quality control can also be connected, regardless of their physical location.

(3) Choose a Solution with Robust Analytics and Reporting Capabilities
Without an effective analytics and reporting tool, the Quality department, as well as management, can be severely hampered in their ability to see trends, anticipate problems, and correct potential quality issues. An electronic solution that offers robust analytics and real-time reporting capabilities, including customized reports and the ability to drill-down to finer detail, greatly enhances quality by providing the information needed for continuous improvement.

(4) Choose a Flexible System that Supports Future Growth
Another important consideration is the software solution’s potential for future growth.  The system should be scalable, or able to support expansion, in terms of users (by the dozens, hundreds, or thousands), business units (domestic and/or overseas), and operations (new products and services). A modular approach allows small start-up companies to automate their quality processes using core applications, and, as they grow, to add more modules.  Choosing a web-based solution provides system access to offsite employees, investors, and vendors, and supports nationwide or even worldwide operations. For large-scale enterprises that have invested in external electronic repositories and point solutions, the ability to integrate with external applications is also important. 

(5) Integrate Training into Quality Management
Current Good Manufacturing Practice (CGMP) regulations require that all employees engaged in product manufacturing to have the education, training, and experience necessary to do their jobs properly. Employees also need ongoing training to ensure adherence to CGMPs. While this requirement sounds simple, many companies fail in this aspect, making training one of the top reasons that companies receive FDA-483 Obs. or warning letters.  Simplifying the training process through automated task assignment, monitoring, and verification can help maintain regulatory compliance.  Online exams, grading, and documentation of test results also help maintain regulatory compliance by demonstrating personnel competency.  In addition, these capabilities facilitate the retrieval of information during inspections and audits.

Your training solution should also allow training courses to be sequenced, so that, as employees complete prerequisite courses, the next course in the sequence is automatically launched. Finally, your Training module should be integrated with the rest of your quality management system, so that any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.

(6) Make Continuous Validation a Strategy for Staying Compliant
All FDA-regulated companies with automated quality management systems must provide documented evidence that their systems consistently produce results that meet predetermined specifications.  This requirement is known as validation.  For many companies, software validation is expensive and challenging because it requires specialized skills and a lot of time (typically several months). The FDA requires companies to revalidate every time they perform a full software upgrade or change their systems. Therefore, as a practical consideration, you may want to look into solutions that allow for “continuous validation.”  A software vendor that provides optional validation tools and customer training on how to use these tools can help with this.  The customer training should include hands-on activities on aspects of IQ, OQ and PQ.  The software vendor should also offer validation services for companies that don’t want to perform software validation on their own.

Conclusion
In conclusion, six ways to optimize your quality management system to help ensure continuous FDA compliance, as well as ISO compliance, include: (1) automate your quality management system; (2) integrate CAPA with Change Control, SOPs, Training, and other relevant modules, so that problems that arise can be easily resolved at levels; (3) choose a system that offers real-time reporting capabilities, customized reports, and the ability to drill-down, as well as advanced analytics; (4) choose a web-based system that is scalable in terms of number of employees, business units, and new products and services; and (5) automate all aspects of training, including task assignment, monitoring, and verification, as well as exams, grading, and course sequencing; and finally, (6) make continuous validation a strategy for staying compliant by choosing a software vendor that offers optional validation tools and training on how to use these tools to complete a validation project. Your software vendor should also offer validation services, should your company prefer not to perform software validation on its own.

Read how MasterControl can help your company automate your quality system:

White Paper:

Six Ways to Optimize Your Quality Management System

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Achieving Quality Across the Global Manufacturing Network

White Paper:

Does Your CAPA need a CAPA™

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Automating Document Control Processes

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Change Control - Quality Improvements




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