By - Kim Wakeman - Product Manager - ETQ
Quality has always been the cornerstone of safe and effective drug products and therapies. Yet, this year in light of the pandemic, the focus on quality against a backdrop of warp-speed vaccine delivery, has been put into overdrive. Pharmaceutical manufacturers recognize that the only way to keep quality on track, proactively mitigate risk and deliver breakthrough drugs in a post-COVID-world is to require a unified quality management approach.
The focus on quality throughout drug discovery, development and delivery processes has given rise to industry standards, such as Good Manufacturing Practice (GMP), as well as the International Council for Harmonization (ICH) and other organizations that share guidance for meeting quality metrics within production, facilities and equipment, laboratory controls, materials, packaging and labeling.
Quality is also the focus of all FDA inspections, which ensure that quality control systems and processes are used throughout the drug and biologics industry to drive continuous improvement. In fact, the FDA’s draft guidance includes an explanation of how the Center for
Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in pharmaceutical manufacturing. As part of its guidance, the FDA encourages the pharmaceutical industry to implement state-of-the-art, innovative quality management systems (QMS).
An automated QMS is becoming the key to success across all forms of life sciences, helping firms meet regulatory compliance requirements, ensure safe and effective products, as well as gain competitive advantage. In fact, according to a survey conducted by ETQ in early 2020, two-thirds of organizations are moving away from quality as merely an operational compliance issue and treating it as a strategic business initiative. It’s moving away from a mere reporting and documentation tool, to a game changer that proactively identifies problems before they can impact the business. For example, a leading life sciences firm has standardized its use of automated quality management to unify quality processes, more accurately capture and share critical quality data and better address and rectify customer complaints across its consumer health products, medical devices and pharmaceutical segments. This includes thousands of products and operations in 60 countries. This focus on quality has become a core part of its digital transformation goals enterprise-wide.
The Obstacles That Can Get in the Way of Automation
Manual processes, siloed data and fragmented systems continue to challenge quality improvement efforts. Consider the following.
Manual processes. It has not been unusual for Quality Assurance (QA) teams to rely on manual checklists and practices to confirm adherence to Standard Operating Procedures (SOPs), document analyses and findings, and manage audits. Fortunately, manual processes that are proven to be error-prone, time consuming and inefficient, are fast becoming a thing of the past.
Siloed data. One of the biggest challenges of Pharmaceutical firms is leveraging all of the insights hidden in the huge volumes of data they gather. Yet, often data points remain siloed in different functions or corporate divisions, and not accessible to people that need it. Also, many firms don’t have the analytics technologies needed to uncover insights in the data to predict future outcomes or identify patterns that need to be perpetuated or rectified.
Fragmented systems: Most firms that have automated their QMS use multiple software tools and platforms across the organization and for different functions. In addition, their extended ecosystems of partners – from materials partners, to Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs), also use different systems. Data coming from different divisions is not visible globally which impedes quality efforts, as well as effective collaboration. A data-driven QMS must enable organizations to harmonize enterprise-wide and ensure visibility across the supply chain for automated and real-time exchange of information, and ultimately greater innovation.
While challenges exist, digital transformation of quality is taking hold, driven by three key technology trends:
- Advances in analytics. It’s projected that spending on AI software will top $125B by 2025, as organizations weave AI and machine learning tools into their business processes. Next generation quality management systems will incorporate machine learning and analytics seamlessly into their functions so that users can capitalize on the sheer volume of data generated and captured in a QMS. Based on advanced algorithms, new QMS systems will be able to not only prompt processes to resolve potential problems, but identify areas of concern so that problems are addressed even before they materialize. For example, AI-driven systems will be able to identify documentation anomalies and help resolve them, or help identify issues that could impact delivery of raw materials from overseas. The data in a QMS provides the perfect fuel for AI and predictive analytics, helping to shed insights that can inform better quality decisions seamlessly within the system. We can expect intelligent quality management systems to quickly gain traction, not only supporting QMS functions, but supporting the decisions made by humans.
- Shift to the cloud. As the rise of remote work during the past year has proven, all business applications must be accessible on any device in the world, at any time. Cloud-based access to quality applications is becoming a key requirement. Even the most regulated industries like pharma, are moving their data center operations to the cloud, and advances in cloud computing are enabling more flexible quality management as a result. Advanced quality software is allowing companies to take advantage of cloud-native technologies such as distributed computing and containerization, to drive high performance, data visibility, dynamic system scalability and massive adaptability to achieve specific business goals. According to Deloitte research, 60% of life sciences and healthcare organizations already run more than half of their applications in the cloud. The industry's cloud adoption spans public clouds and private clouds as well as SaaS packages.
- Acceleration of digital transformation post-COVID-19. The pandemic put many organizations into crisis-mode, and caused them to put their digital transformation initiatives on the back burner. Yet, as we begin to emerge, they are realizing the benefits of digitalization and looking to revisit their strategic initiatives. In fact, McKinsey estimates the pandemic has fueled a three- to four-year acceleration of companies adopting digital technologies to support their customer and supply chain interactions. An effective digital quality strategy can serve as a catalyst for digital transformation, bridging the gap between quality operations and the business, and expanding quality management to all stakeholders. This creates unparalleled quality alignment, clear visibility and unprecedented productivity, essential to ensuring the success of digital transformation.
What Should You Look For in a QMS?
Driven by digital transformation initiatives, advanced quality management systems can help pharma firms more easily ensure compliance with FDA, GMP and other regulatory requirements, but also adherence to internal SOPs, mitigate risk and proactively address problems before they occur. What should companies look for in a modern QMS? Consider the following five features
Cloud-native. While Software-as-a-Service (SaaS)-based QMS provides a more modern solution to on-premise solutions, if it’s simply a hosted version of an on-premise offering, the ability to efficiently integrate advanced infrastructure can be limited. In a true cloud-native environment, continuous innovation is all but guaranteed as the “back end” of the system in the cloud is refreshed with new technology from the hosting provider and can be easily integrated into new applications and front-end capabilities to drive scalability, maintenance and security. When selecting a cloud-based QMS, inquire if it’s truly could-native.
Usability. If you’ve been unable to find a critical piece of information, you understand that systems can often be obtuse when it comes to their ability to deliver data. Humans, also, are terrible when it comes to organizing file systems. Your QMS should offer a search interface that can find any quality document across the enterprise.
Flexibility. Your QMS should conform to user needs, not the other way around. It should be able to easily connect to other applications and add suppliers in order to collaborate more closely without risking a data breach. Suppliers in turn now have the ability to understand your quality requirements more closely and participate in your quality workstreams such as supplier corrective actions, which means they can be more responsive to your requirements and are less likely to churn.
Analytics. An advanced QMS should allow you to spot trends, understand key metrics and take informed action quickly and easily via pre-configured dashboards that identify important trends, such as nonconformance events, audit progress and other vital quality components.
As Artificial Intelligence (AI) becomes further ingrained in quality management, new QMS solutions will be able to capture and classify quality issues faster and more consistently and uncover relationships and patterns to identify related events more accurately and easily in order to accelerate investigations and root cause analyses.
Adaptability. The pharma industry and its development of drug products and ingredients is marked by unpredictability, requiring continuous changes. Your QMS should be able to adapt to changing business requirements and enable seamless system upgradability without impacting those changing needs. As the pace of pharma innovation accelerates in 2021, maintaining adherence to regulatory controls is not enough. While a compliance audit tells a manufacturer whether a product is compliant with current FDA and other regulations, it offers no insight into how that company can improve its development and manufacturing processes, manage workflows, optimize collaboration, anticipate and mitigate supply chain issues, minimize risk and safely deliver drugs to consumers who need them the most. Digital transformation through an advanced QMS is able to achieve these goals more intelligently than ever before.
Kim Wakeman, Product Manager, ETQ, has more than 20 years of experience working in the medical device industry. Prior to ETQ, she managed quality assurance and regulatory aff airs for a medical device manufacturer. Her industry experience has provided her with a valuable understanding of business processes and the best methodologies to implement them.
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