Connecting up regulatory compliance
We are excited to announce the release of Central Management for OmniTrust, brand-new functionality that improves the user experience of Aeris, Empyrean and Zetasizer Advance users, particularly those working in the regulated environment.
What customers told us
In the world of drug development, data integrity is key to giving both regulators and developers confidence that the correct processes and procedures have been followed, and that products are safe. However, for pharmaceutical scientists working in the lab, meeting the required standards for compliance can become a significant burden. Talking to our customers on the subject, we frequently hear phrases such as:
- “Instrument compliance has become more important to us than instrument performance”
- “Every hour in the lab requires a further hour doing the admin”
- “At least an hour analyzing each sample, plus another scientist’s review, before it goes to QA”
Better tools for data integrity
We also hear how frustrated customers can become with each instrument in their lab having its own ‘data integrity tools’, each of which works differently. Consequently, users not only need to learn how to perform the relevant measurement on each instrument but also how to navigate the data integrity and audit review workflow of each system.
Customers also told us that it would really help them if they could manage system configuration and perform audit reviews remotely. This would allow instruments to be used more efficiently, with measurement workflows remaining uninterrupted by routine administrative tasks that could be performed elsewhere.
Making your job easier
When developing OmniTrust, our solution to help our customers comply with data integrity requirements, as some of our team explain here, we were determined to make their jobs easier! We took the first steps towards this when we were joined by some of our colleagues from Concept Life Sciences at the launch of OmniTrust last year. As well as providing easy-to-use tools that work across different networks, we aligned the platform across several of our instruments, starting with Empyrean, Aeris and Zetasizer Advance. As a result, our customers will be familiar with the same data integrity tools, no matter which instrument they’re using. Of course, our research told also us that there was an opportunity to go beyond this, and that’s how Central Management came about.
Introducing Central Management
Central Management allows your team to perform administrative tasks such as role configuration and updates (including, allocation of permissions and user management) from multiple workstations – even those in different countries. What’s more, all system audit trail (SAT) entries are combined into a single system audit trail, allowing you or your QA team to perform audits of the SAT across the whole centrally-managed network (assuming you have permissions to do so, of course!). So, when a measurement is recorded in Data Collector and further analysis is performed in Highscore using a different workstation, you can see all the relevant entries in one place. Alternatively, if you need to see who has been using your Zetasizer Advance in Lab A and your Aeris in Lab B, you can do that from your desk, and create an event in the SAT to show that you have audited it.
See Central Management in action
We’ve recorded a demonstration of how Central Management works, with our very own Product Group Manager Fabio Masiello in Almelo configuring roles so that our colleagues Martin and Jake can use instruments in our labs in Almelo, NL, and Malvern, UK respectively. Then it was my turn to carry out an audit on all those activities from Malvern, without ever having to leave my desk with its view of the famous Malvern Hills!
Find out more about OmniTrust’s Central Management by watching this video.
Further reading
- OmniTrust: Making the impossible possible!
- OmniTrust – Your questions answered
- The launch of OmniTrust – our solution for the regulated environment