What you need to know about building quality excellence in the lab
Dr Daniela Jansen shares what is holding organizations back, how disconnect leads to inefficiency and how to create a culture of quality
Maintaining data quality and integrity can, at times, feel more like a burden than a benefit.
In this interview, we discuss with Dr Daniela Jansen, Director of Product Marketing at Dassault Systèmes, how to battle organizational disconnect and benefit from a holistic approach to quality. She offers insight on how to build quality excellence in the lab and why reliable data is the key to collaboration.
Deep Dive:Join Daniela and Steven Brown, Data Integrity Lead at Novartis, for their webinar at Smart Labs Digital. Secure your place here
Pharma IQ: What do you think is stopping organizations from achieving quality and laboratory excellence?
Daniela: I think the most important thing is that there is often not a true adoption of a culture of quality. By that, I mean a comprehensive, holistic approach to quality.
Organizations have a quality department, which is often separate and seen to be creating a burden, rather than a department which is helping an organization become better. Not only by helping them to become compliant with regulations but better in their overall processes and their entire approach.
Organizations need a culture of quality so that everyone acts with quality in mind. Once people have a broader approach to quality, you can transition from a separated, isolated department for quality to all areas of the organizations embracing the need for quality.
Organizations must act with quality in mind and this starts with research
This starts with research, so the researcher takes ownership that they will record what they are doing and ensure that there is high quality of the data. On the one hand they can ensure that they are making the right decisions based on the right data, but they can also use this data as a foundation for patent submissions or for future contextual reviews of their decisions.
This is part of the value chain for the entire organization. It starts with research, then development and then manufacturing and then down to commercialization. Once you take a holistic approach across the entire organization, you can ensure that you are compliant and that you maintain a high quality of data.
While this is the case for any department, the lab is a great area to begin with. The lab is involved in many different activities throughout the value chain that define the product characteristics and quality. And handling data, applications and processes with quality in mind will already set a great basis.
Pharma IQ: How does organizational disconnect lead to inefficiencies?
Daniela: So this has an impact on efficiency but also on quality.
Organizational disconnect is very often reflected in the systems used. So one department has deployed one solution, another is similar but from a different vendor and another is home grown. This hinders the flow and the sharing / reuse of data. Sometimes organizations try to overcome this by trying to integrate their legacy systems and the IT department is just stitching it all together. But these are just point-to-point integrations and don’t allow for true digital continuity impacting quality and efficiency across the entire system.
Simple point to point integrations can lead to organizational disconnect. This slows down the sharing and reuse of data
When you have different departments, different people, different systems, different applications and different mind-sets; efficiency is limited.
Find out more: Discover how to drive efficiency through data integrity
Pharma IQ: What can a company do to start building a holistic attitude towards data quality?
Daniela: There are two approaches that need to be run simultaneously.
The first is to support of a culture of quality and data integrity through a simultaneous top-down and bottom-up approach. By top-down, management must encourage and incentivize departments to collaborate on quality. They must be open to approaches that improve quality and put focus on the long term positive results for quality and the overall business. On the bottom-up front, there must be champions at all levels who embrace quality and have a quality mind-set. These people can engage their peers and show the value that for example data integrity can bring, not only for the organization but also on a personal level.
By simultaneously leveraging technology and culture, you can drive change in data quality
The second approach is definitely leveraging technology that will make the process easier. People don’t ignore quality processes just because they don’t want to do them. We find there are two reasons why they are not following the correct processes. Firstly, they may not be aware of the relevance of this process, which we can be fixed with training. Secondly, the actual task may be too cumbersome. This can be addressed with technology, by deploying easy to use applications and by integrating these different applications so data transfer is automatic instead of manual. This removes errors, increases the quality of data and also makes it easier for people to work in a quality aware environment.
With modern technology and the right mind-set, these are two levels where organizations can be really successful to achieve quality and data excellence and lead to business excellence – with compliance as a “by-product”
Pharma IQ: Do you think there is often a misconception that data integrity has to be more difficult than it is?
Daniela: Yes. For people who have been working in a certain way for a certain number of years, data integrity can sound like a complex task. It is a change of working the way they are used to and they need to work within a new system which requires a change of focus onto different things.
Data integrity, when it’s not supported by technology, can be cumbersome. You need to follow key principles to ensure correct data entries and transfer for example with the four-eyes-principle where another person is validating data input.
Data integrity, when it's not supported by technology, can be a cumbersome task
There is a perception that it is difficult and that it might hinder efficiency, but with the right technology it is the complete opposite. Once systems and interfaces are validated, automation can fully support data integrity and make it far easier with significantly less effort.
Pharma IQ: What are the benefits for collaboration and innovation when you have a strong focus on data integrity?
Daniela: Effectively, your data becomes reliable.
When you are innovating you want to be able to access the data and collaborate. This requires a mind-set that people are willing to share their data and also technology to support the transfer of data with context.
When you have data integrity, you data becomes a reliable source of information that can drive future discoveries
Data integrity offers real confidence that you have access to both, good quality and reliable data. This stops you from having to base your innovations on assumptions, incorrect data or incomplete data and having poor quality trickle down. Your decisions become more trustworthy and traceable.
Digital continuity along the value chain is crucial. Having an environment that enables data flow, back and forth, of high quality data across the entire product life cycle is a contributor to Quality in the broadest sense and supports Business Excellence.