I have worked in the analytical instrumentation business for X-ray diffraction (XRD) machines more than 20 years. In this time, technical innovation has always been the main driving force for new business. Can we measure faster? Increase detection limits? Add more applications? Switch between methods more quickly?
When is compliance more important than performance?
In the heavily regulated pharmaceutical environment, where customers must take a risk-based approach to data governance, a key question from our customers is: can we make your instrument adapt to our processes? One customer put it very simply, saying: “instrument compliance is more important than instrument performance”. So, for this group of customers, we must consider how software can help ensure compliance.
What do customers want?
In the early phase of this project, we interviewed several customers to better understand their concerns and wishes. The recurring feedback was:
- “existing solutions do not match our workflow and we spend a lot of time on administrative tasks”
- “one hour of lab work equals one hour of admin”
We asked ourselves what if we could reduce that time by 10-20% for every sample?
Another aspect that came back often was confidence:
- What if our server crashes?
- How do we recover from a backup?
- And most importantly: can we confidently show everything when the auditor comes?
Based on these inputs, we started to build a software solution that provides a common approach to validation and data integrity across a range of Malvern Panalytical instruments. We chose three products as initial targets: Zetasizer, Aeris and Empyrean, and aim to add other product lines in future.
One team, one goal
This was a large project that required a large team, spread across different functions and three different sites in three countries. In the beginning, we had to get to know each other and find new ways to communicate. When COVID-19 hit us, we already knew how to work online and had the systems in place that meant we could progress with little delay.
We are now proud to introduce our new solution: OmniTrust, a suite of software and system verification tools required to streamline how you validate and audit the operation of your instruments. With OmniTrust, customers in the regulated environment can optimize the efficiency and compliance of their instruments, people and processes.
When showing the results to the customers we interviewed in the beginning, we received very positive feedback on the comprehensiveness of this solution. They were also enthusiastic about the possibilities it delivers for process efficiency improvements. I am very proud of the work done by this team, and I am confident about the adoption of this new solution by the market.