Integrating pharmaceutical functions: Using quality insights to drive safety operations
As the life sciences field becomes more complex, it is apparent that many aspects of product quality and safety processes are inextricably linked; when quality dips, safety teams can expect that an increase in reports of adverse events (AEs) and product complaints is very likely to follow. When approaching safety operations, it is key to recognise and leverage the relationship between quality and safety operations.
Managing product complaints is not only a best practice for life science safety teams, but it is also regulated and required by global health authorities. Ensuring patient safety is of the utmost importance for life science organisations, and using quality insights to help drive safety operations is an efficient and streamlined way to manage product quality and complaints.
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The relationship between quality and complaints continues to grow, especially as the amount of overlapping data collected by quality and safety teams increases exponentially. Sources for safety data, such as social media platforms, are gaining popularity for being tools to share patient questions and experiences with pharmaceutical products. The complex task of monitoring these platforms for safety and product complaints is necessary to improve product performance, scale to meet shifting regulatory and market demands or address quality and safety issues, but can also place a burden on safety teams.
The challenges that surround quality assurance are compounded by the necessary collection, storage, analysis and activation of copious amounts of data. For example, social media recorded 50 million conversations exclusively around COVID-19 weekly in 2020. As data pours in from various sources, balancing shifting global regulations and product complaints while maintaining quality and safety is not a simple task.
Traditionally, product complaint management has been a tedious, manual, and error-prone process. The plethora of complaint data quality teams must sort through and manage can lend itself to human error and delay. The best and most efficient method of handling this data is technology, and this is where the benefits of using quality insights to drive safety operations emerge.
The link between quality and safety is growing
With increased complexity, it is crucial for product quality and safety teams within the life sciences field to rely on every tool at their disposal. By using quality as a principle for safety operations, real-time information can be shared, identifying, and resolving critical issues more efficiently. Using technology, such as quality management systems (QMS), to integrate pharmaceutical functions like quality insights for safety operations is integral to achieving quality assurance in life sciences. This integration can improve both compliance and efficacy of products in the market.
A combination of safety and QMS can reduce the ever-growing burden of data on safety teams. These systems can provide clear insight into what is working versus what is not to enhance product quality and safety while also reducing risk. QMS and real-time information sharing between quality, regulatory and safety teams can result in both optimised support for marketed products and accelerated time to market without sacrificing product quality or safety. The early detection of quality issues not only improves and shortens product cycle times but also assures compliance with all standards for quality, safety, and regulatory processes.
The benefits of combined operations
When different technologies that work to address concerns in multiple focus areas are used in conjunction with one another, already great products can be further improved upon. The benefits of combined systems go beyond just connecting and streamlining processes; the data gathered from the integration of quality and safety technology allows life science companies to pivot quickly to revise products as needed. Organisations can quickly address any safety concerns or quality complaints – much faster than if the systems were separate. Integrated quality and safety systems are very valuable tools for completely transforming a life science company's innovation efforts and, without the combined operations, it is almost impossible for life science companies to validate the quality of both their products and services.
The integration of disparate compliance functions through technology, analytics and services allows for more automation and less manual work. Leveraging advanced analytics, including artificial intelligence and machine learning, can drive better results in quality assurance and complaint management, as well as improve overall compliance with regulations. This can reduce many of the manual and highly repetitive tasks, allowing teams to focus on higher-value activities. Thus, automation directly drives better results.
The merging of life science company functions leverages the relationship between the multiple operations to provide more meaningful and actionable insights. Connecting quality and safety systems into a singular, integrated solution can shorten cycle time, identify issues more efficiently, act faster as a result, improve overall compliance and enable market surveillance of post-market launch products and provide more information and perspectives. The relationship between quality and product complaints is strong. Safety teams can use QMS-driven insights to improve compliance and efficacy of safety operations.
