Thermo Fisher Pharma Services deployed Thermo Scientific™ SampleManager LIMS™ software as the digital backbone of its Pharma 4.0 vision. Pharma Services provides industry-leading, end-to-end capabilities to simplify the supply chain for its customers. With expertise in drug development, clinical trial logistics and commercial manufacturing, Pharma Services’ flexible business models and global network of 55+ sites support customers from development through commercial supply.
Pharma Services’ Global Quality Systems leaders say the deployment of SampleManager LIMS software supports the organization’s quality control strategy. They also anticipate immediate benefits to their customers.
Speed to market
“The race to produce medicines, whether they’re vaccines, therapeutic medicines, companion diagnostics, has accelerated the pressure on pharmaceutical companies to deliver speed and effective medicines, vaccines, and treatments that were unheard of many years ago,” said Bill Weiser, Senior Director Quality Systems, Global Quality Assurance, Pharma Services. “Our customers demand speed to market, and that includes everything that goes throughout the development process.”
Weiser expects the efficient data management capabilities provided by SampleManager LIMS software will help bring products to market more quickly. “There’s a tremendous amount of data that’s generated through development, whether it’s supporting trial formulations, stability programs, engineering runs, process validation runs, and commercial manufacturing. Having an effective LIMS platform will accelerate our ability to accumulate this data, turn it into information and use that for wise and sound product decisions, preparing us for expanding our capability, our capacity, and the speed with which we can address unmet medical needs.”
The enhanced data management capabilities can also simplify regulatory submissions, according to Weiser. “As a customer then prepares their regulatory submissions, being able to quickly consolidate stability data from multiple systems will enable and simplify their ability to submit those product registration documents, annual updates, etc. to achieve a quicker and more efficient regulatory submission and hopefully rapid approvals.“
Simplifying the customer experience
When selecting a LIMS platform, one of the key requirements was simplifying the way a customer interacts with Pharma Services. The business develops and manufactures products for customers at multiple sites within the network. They needed a platform capable of managing data across those 55+ sites, presenting that data in a consistent manner to the customer.
Tanya Tadey, Director of Laboratory Systems and Technology, Pharma Services, believes the SampleManager LIMS implementation will streamline the customer experience. “Customers will benefit from a much more seamless experience as they work with different sites in the network,” she said. “So, for example, certificates of analysis, stability protocols, and reports will all follow the same format regardless of the site that they are generated in.”
Like Tadey, Weiser looks forward to an improved customer experience through the new global LIMS implementation. “Having a global LIMS means that we have one access point or one standard way in which we collect data, and then also a way that we can present it to our customers. Regardless of what site our customers work at, having a common global system will enable us to provide that same quality, that same level of data, and have that same compliance so that the customers trust no matter where the data is generated.”
Enabling advanced data analytics
Saly Romero-Torres, Senior Director Digital Quality Systems, Pharma Services, anticipates using the advanced data analytics capabilities available in SampleManager LIMS to provide customers with a new level of visibility into their data. “One of the things that we want to do is to create portals where we can provide our data to our customers,” Romero-Torres said. With secure access to this data, customers can leverage existing data analytics and data mining tools for a new level of insight. The result is more informed decision-making and better visibility to the bigger picture.
Tadey also sees the potential of the system’s analytics capabilities. “This will allow us to work with our customers to much more quickly correlate, interpret, and report complex data from various sources,” she offered. “Customers can directly use this data in their submissions, or to identify and act on any trends in the data,” she concluded.
To hear more from Bill Weiser, Saly Romero-Torres and Tanya Tadey on how customers benefit from SampleManager LIMS software used at Thermo Fisher Pharma Services, check out our video. You can also visit our website to learn more about SampleManager LIMS software and Thermo Fisher Pharma Services.