Pharmaceutical companies rely on quality management systems (QMSs) to maintain and improve product quality and minimize risk, as well as ensure patient safety and compliance with regulatory requirements. Increased technology adoption and the tightening of regulatory requirements are causing an exponential increase in the amount of data that must be analyzed for quality insights and compliance. As a result, pharmaceutical companies must modernize their QMS to provide equal or greater value in today’s world of digital tools and information. Achieving quality maturity through modern QMS capabilities is critical when pharmaceutical companies are faced with a potential audit.

Increasing Quality Maturity
Organizations that possess greater quality maturity benefit from reduced costs related to quality management and governance improvement. Quality maturity is a gradual journey with key milestones to accomplish as organizations adopt next-generation QMS capabilities and processes.

In the initial stages of quality maturity, organizations depend on manual and reactive approaches. Organizations in this stage are simply trying to maintain regulatory compliance, rather than improve the quality of their products. It’s not that they don’t care about quality or patient safety, but they’re struggling with leveraging outdated processes and technology to perform 21st century quality management and simply cannot keep pace with the increase in data and regulations, such as new standards including the European Union Medical Device Regulation (EU MDR) and good practice (GXP) readiness and compliance.

As a pharmaceutical company and its quality team climb the ladder to quality maturity, their operations become motivated more by ensuring product quality for patient safety rather than simple regulatory compliance. This is because they now have the tools and capabilities to perform modern quality management with a next-generation QMS, including integrated quality and IT systems. Here are five key characteristics of next-generation QMS that will help organizations know they’re reaching their quality maturity goals:

1.  Built for Life Sciences
As regulatory requirements become more stringent, it becomes critical that an organization’s QMS is compliance-ready and closed-looped for accuracy and efficiency. Eliminating silos, driving harmonization, reducing overall cost of quality and enabling informed, data-driven decisions by leveraging a QMS designed for and built by life science professionals. This will help pharmaceutical companies and quality teams adhere to new and shifting regulations, such as 21 CFR Part 11.

2. Quality Intelligence & Reporting
To make informed, data-driven decisions, teams need access to complete and accurate QMS data. Quality teams need instant feedback and insights into quality trends to make informed decisions, which can be provided by business intelligence (BI) capabilities combined with regular reports.

3. Cloud Enablement
Cloud environments built for life science operations are incredibly secure, reliable and efficient. This not only protects data in a compliant environment, but also enables businesses to scale QMS and quality operations to meet shifting requirements and business needs.

4.  End-to-End EQMS Deployment & Optimization
To optimize next-generation QMS deployment, engage a QMS provider that possesses deep understanding of the life science industry and industry requirements. This will ensure the provider can guide pharmaceutical companies in their journey to process harmonization and quality maturity.

5.  Intuitive & Modern User Interface (UI)
Easy-to-use interfaces improve user adoption of new QMSs within quality teams and allows for easier expansion of users across the organization. Pharmaceutical companies will know an interface is intuitive when it can assist in shortening cycle times, reducing errors and minimizing training needs. It needs to be simple enough for a casual user to navigate, but in-depth enough for experts to get the information they need.

Once organizations achieve the highest level of quality maturity, they begin to establish a true culture of quality, with the ability for metrics and insights to not only sustain but improve quality and safety. Organizations with quality maturity will experience improved compliance and reductions in the cost of quality assurance and will be better positioned to handle the next phase of tightening regulations or challenges regarding product quality.