Like two supporting pillars, processes and data hold the key to unlocking excellence in life sciences quality management. If these components are not in control, your business is at risk. But with the right approach, a well-organized QMS and a robust data model, you can transform that risk into an advantage.
– Mette Pedersen, advanced business consultant, NNIT.
– Arnaud Maillard, principal business consultant, NNIT.
In the life sciences sector, processes and data go hand in hand as the stable foundation and pulsing energy of the business. Every day, business teams work diligently with a multitude of processes such as reviewing documentation, conducting quality control testing, managing deviations, and performing internal audits.
While doing so, they generate crucial data that drive continuous improvement and maintain high standards. For example, a robust and well-designed deviation management or supplier quality management processes not only enhance operational efficiency but also provide valuable insights for being in control, mitigating risks and addressing poor quality efficiently.
But all too often, business teams encounter built-in contradictions in the workflows, find themselves searching through a scattered document landscape which, at the end of the day, result in workarounds be developed because more convenient than a heavy, unclear and unorganized process.
Thankfully, the digital marketplace offers a lot of opportunities not only to keep control of the situation but also to take advantage of all the precious data entered and produced by your processes – but only as long as your quality management system (QMS) and data management are well organized.
No matter which digital solution you have adopted, it is only a reflection of your organization. Your QMS may be compliant and ensure that you follow the requirements of the authorities. But today, compliance is not enough. It’s about delivering high-quality products while navigating your own business objectives, the regulatory landscape, customer needs and the competition.
Discover the true state of your QMS
So, have you ever stepped back and really looked at your QMS? It is easier said than done, as there is rarely time to study how the processes and data interconnect. But making the effort can be a worthwhile investment, as it can lead to greatly improved efficiency or reveal a need to update your QMS.
Here are a few questions that might reveal a great deal about the true state of your QMS:
- Newcomer’s Perspective: Slip into the shoes of a fresh recruit. How does your QMS appear to them? Is it a cryptic labyrinth or a will-lit path?
- Document Quest: How swiftly can you find the documents to operate a task or record an activity? It should not be a document hunt.
- Process Interactions: How easy is it for employees to understand their role, the allocated activities, and how it interacts with the input/output of other processes?
- Data Appetite: How much data is requested by your processes and what is currently analysed? What role do these data play in the improvement of your processes and business?
Answering these questions helps you to health check your QMS and realize it needs to be improved and/or re-vamped to provide more value, such as a better decision-making process or a more efficient data model. You may also realize that the solutions you have implemented are not used to their full potential.
The dual perspective of process and data
At NNIT we have developed a Process and Data Centric approach solution helping our customers to revamp their QMS to move from a compliant status to a performance-focused status and beyond.
As part of this approach, we view your business and your QMS from two different, but equally important perspectives:
- The Process Perspective: Focuses on well-defined workflows and adherence to processes. By understanding how processes function and interact, organizations can monitor and control their performance effectively, and it is easier to identify areas for enhancement, assess risks, and validate changes.
- The Data Perspective: Focuses on quality data management, transparency, and data-driven decision-making. Analysing quality data helps organizations identify trends, root causes, and areas for improvement. For example, do you request data from your users as free text or pick list? Is the necessary data available or trapped in inaccessible documents and presentations?
Combined, these two perspectives enable you to streamline and harmonize your processes, so they become as efficient and easy to use as possible and utilize the data that is essential, neither more nor less.
Why choose NNIT’s approach?
NNIT’s process and data-centric approach provides multiple benefits, such as:
- A holistic approach: Your QMS and the related digital solutions are no longer impacted by siloed decisions and disconnected processes.
- A clear and harmonized QMS: Everyone talks the same language, both in terms of business and IT communication, and it is easier to understand what they have to do, when, how, and what has to be documented in related digital solutions.
- Improved and simplified digital solutions: The user acceptance of the tools is higher for better data integrity and more reliable data.
- A simplified QMS: Helps identify redundancies and unnecessary or repetitive activities and allows easier and quicker improvement.
- A robust data model: Structure information logically and systematically and ensure data is organized in a way that makes it easy to understand and manage.
- A well-designed data model: Provides accurate and real-time insights and data-driven decision-making becomes possible.
- A process and role-based QMS: This will help adopting a process and role-based training approach that ensures the right content reaches the right people.
We know that aligning the whole organization on a new paradigm is difficult but essential for success. Our teams are fully dedicated to helping you in this journey to a process and data-centric QMS.
