Life sciences companies continue to feel growing pressure around the issues of quality and compliance. When attempting to sort through these complexities, it is imperative that organizations leverage an in-depth understanding of the complex regulations that govern quality and compliance and finding a way to ensure that the company’s best practices and record-keeping can stand up to an audit.
They must also deploy and maintain systems that are efficient and cost-effective and will deliver the greatest overall value. This also relates to the critical need to tap into brand new efficiencies and avoid the pitfalls of disparate or unnecessarily complex systems.
These issues are at the core of the challenges for many in the industry. Let’s consider the key challenges facing the industry and how to alleviate them with the capabilities of a digital quality management system (QMS).
Common Challenges in the Life Sciences Industry
Companies that use a traditional, manual quality management approach are often faced with a set of core challenges, including:
- Not Leveraging Best Practices: Industry best practices are typically well established and following them not only ensures quality, but it also helps companies meet regulatory compliance.
- Lack of Scalability: Companies of all sizes seek to grow, and quality systems should be able to grow with them, not hold them back.
- Siloed System: Avoidance of quality silos is one of the most important keys to efficiency and rapid response to quality events.
- Cost of Ownership: Most IT organizations are already resource-constrained. Minimal dependence on these resources will mean faster implementation and, in the case of web-based solutions, guarantee on-time maintenance and upgrades.
What to Look for in a Best-in-Class Quality Management System
Not all solutions are created equal. When looking into the best digital QMS for your organization, consider whether the solution addresses the challenges above by including the following:
- Integrated Best Practices: Companies should not have to reinvent the wheel when it comes to accepted best practices and validation criteria, particularly when expert support is available. Digital QMS solutions enable companies to leverage proven quality workflow best practices.
- Scalability: The combination of new products and expanding markets in manufacturing is sure to drive growth for many companies. Growth, in turn, means more data and more complexity to be managed. For example, when an American company starts doing business in Europe, it must deal with a new set of regulations. Companies must take care to invest in a QMS they won’t outgrow at a critical moment in their development.
- Unified Solution: Using an end-to-end digital system for all quality-related processes breaks down silos and offers closed-loop tracking and reporting throughout the workflow process.
- Minimal IT Impact: Cloud-based systems minimize the impact on IT teams because the provider’s servers are always ready to maintain and manage the system. The quality team benefits from the latest functionality upgrades and security updates, rather than having to wait for IT to find the time to install them. This means the IT team can focus on other value-added activities.
Get More Insights into the Value of a Digital QMS
Another value found in digital QMS is the ability to deliver innovation and new technologies. The evolution of QMS software is speeding up as organizations find new ways to apply Quality 4.0 capabilities, such as artificial intelligence (AI), to complex manufacturing and distribution processes. A digital QMS solution enables companies to leverage these innovative leaps in quality management.
Faced with the challenges above? Learn how the digital QMS can help companies alleviate common challenges and provide the best practices needed for success by downloading the eBook below. You’ll get more insights into the capabilities provided in a digital QMS and gain access to a demo to see these features in action.