Professionals who have spent a career in the life sciences field can recognize immediately a new idea that will dramatically improve life as they know it for their customers and colleagues. That’s why the OpenText™ Documentum™ for Life Sciences team is so enthusiastic about OpenText™ Core for Quality Management, which has its first release this month with availability to qualified customers and partners. OpenText Core for Quality Management is a SaaS application built on OpenText™ OT2, a flexible, hybrid platform for Enterprise Information Management (EIM) services and applications.
To set the stage: In life sciences, regulatory compliance is an everyday fact of life, and quality is its very foundation. But with complex regulations come complex workflow processes, especially for handling and reporting on non-conformance and corrective and preventive actions (CAPA). That’s the problem Core for Quality Management solves by simplifying.
Fulfilling a need for ease of use
When we started working on OpenText Core for Quality Management development, one of the main areas of focus was usability. Everyone today is used to working fast, with the ability to complete a task or activity with a single click. That is just not possible with the tools they have today.
Core for Quality Management features an intuitive, comprehensive user interface that is adaptable to the role. It delivers everything at one glance, with one click and easy navigation to what’s relevant.
Just as important is that the quality processes are natively connected to the documents that support it, or documents that are affected by the process. Core for Quality Management is integrated with our enterprise document management system (eDMS) for promoting efficiency and ease of use, while eliminating the need for custom integration development and maintenance.
With a state-of-the-art analytics engine built in, it’s possible to extract, analyze, and navigate data with visuals and drill down capabilities. The applicability is virtually endless – from simple reports to complex dashboards and trends analysis.
Simplifying workflows and connecting information
According to Juan Aponte Luna, Quality Product Manager at OpenText, companies have typically taken a “nuclear approach” when designing workflows, building in more rigor than necessary to cover all bases. Many times, simple issues have to follow the same process as with major problems. In other cases, there are too many procedures to follow, and a lot of them are repetitive and unnecessary. And nearly half of the processes are manual!
Connecting content with processes is essential. When systems are not integrated, processes are broken and documents are poorly maintained and outdated. For example, a document lists a reference to another document that’s since been superseded. Or, say you want to record an issue on the manufacturing floor. First, you must log in to your quality management system (QMS) and record the issue, then log in to the eDMS, find the relevant document, and manually record the traceability data in both places.
The problem is compounded by lack of proper training and sporadic use of tools, Juan says. “I remember working with systems with many one-time users. In one case, these people had to read three very large decks, and then follow a process requiring more than 30 entries!”
When it comes to measuring process effectiveness, they are usually dealing with bad reporting tools. Systems are limited in the kind of reporting information they generate and often return thousands of unnecessary values, which makes users miserable. Then they are unfairly held accountable for the reports.
Besides system design issues, there are many factors that cause difficulties for users. The reality is that their operations require them to move with speed and certainty, which is impeded by this clumsy workflow. Overall, insight is sacrificed because of the demand for speed. But in fact, speed, insight, and certainty can coexist through ease of use.
Delivering speed, insight, and certainty
CAPA is like a big puzzle. But when the pieces are preassembled, you get a head start. You can visualize that puzzle in ways you can comprehend – for instance, with a single screen that presents root cause analysis with drill-down to actions you need to complete. The system is designed to make you follow the process in the right sequence, with controls built in so you can’t skip a step, and automated workflows that eliminate repetitive work.
When it comes to reporting, the tools are just as simple to use, with quick linkage to accurate supporting documents. This helps with tracking trends and issue descriptions, isolating frequent sources of error, and detecting when the same issues arise repeatedly. Companies need this for compliance and audit readiness and, of course, to apply what they learn internally for continuous improvement.
A timely offering that boosts efficiency
Lena Shafir, Director of Life Sciences Product Management at OpenText, explains why Core for Quality Management is so timely today. “In the early days of investing in electronic systems,” she says, “the big worry was compliance. Now that compliance is built into mature enterprise systems, a lot of them are still operating in silos. This prevents organizations from achieving the full benefit from their investments. To enable effective use of electronic systems, we must be able to provide integrated solutions – ideally, natively integrated.”
In life sciences, quality is always top of mind. Compliance touches everything we do. But to be effective, quality processes must be efficient. As you saw with the example of the disconnect on the manufacturing floor, siloed systems do not support productivity or efficiency. With Core for Quality Management, all that changes. Now, the integration is seamless. The user on the manufacturing floor or in the warehouse can trust the integrity of the processes, be assured of the accuracy of the documentation, and make decisions with confidence. Users responsible for handling nonconformance and CAPA events can do their work much faster and more accurately.
When you realize that efficiency equates to the quality of the processes, it becomes clear how revolutionary this will be.
To learn more about Core for Quality Management, please visit our website.