What's Trending in Pharma IT?

Operational transparency and optimized processes from lab to plant floor to executive suite and back are driving IT investments

By Steven E. Kuehn, Editor-in-Chief

5 of 5 1 | 2 | 3 | 4 | 5 > View on one page

Thermo Fisher Scientific’s Meek knows that lab informatics platforms truly are the pointy end of the spear when it comes to assuring quality when it counts. “Ensuring product quality, risk reduction and regulatory compliance have always been among the top reasons to deploy a LIMS, she says. “Test results from suppliers are checked to ensure they are fit for use before time and energy is wasted, all sample results for the batch including environmental monitoring are collated before product can be released. Business processes are implemented in the LIMS and the users are [systematically] stepped through the organizations’ SOPs to ensure compliance. Hazard warnings can be associated with any step in a workflow and, within the LES, users are reminded as they execute that step of the appropriate safety procedures including safety images and videos if appropriate.”

It’s important, says Meek, to remember that today’s LIMS are far more than just lab information systems. “It is also a laboratory resource planning system. Method execution, scientific data visualization, instrument calibration and maintenance, and detailed resource planning and allocation can all be done through the LIMS.” Typically, notes Meek, LIMS are on an upgrade cycle of around every five years, and the first thing Thermo Fisher Scientific does with its customers is demonstrate how much the functionality of its platforms have evolved since initial implementation and work with them to leverage the new capabilities of the system. The focus, she says, is to deliver on high-level organizational goals by leveraging their existing investments in laboratory instrumentation, informatics and enterprise systems. “And while the concept of a truly ‘paperless lab’ has been hotly debated for many years, it is really only now coming into its own. The latest Informatics solutions are capable of fully integrating the lab to the rest of the business, eliminating for the most part many of the paper-based processes that have caused bottlenecks in workflow or contributed to errors in transcribing results and generating reports.”

Because LIMS are tightly integrated with other enterprise operation systems such as ERP, insights from the lab have the potential to be even more central to businesses seeking true enterprise-wide agility says Meek. “Businesses aren’t simply capturing and collecting data; they are making data actionable across the enterprise, putting management in the position to transform their businesses into agile organizations capable of responding quickly to market trends or new regulations and flexible enough to recognize and capitalize on cost-saving or margin-growing opportunities in the future.”

Rockwell’s Life Science manufacturing customers, notes Vogel, are moving to maximize their operating options by standardizing the underlying recipe and execution process around five imperatives: product quality, cost control, safety, risk reduction and compliance. This will maximize quality adherence, reduce risk and minimize cost variations from plant to plant. “To ensure product quality, for example, enterprise MES coupled with advanced EMI software is being used by manufacturing and IT teams. Reports are produced throughout the day by aggregating data from machine, plant, enterprise and third-party applications to produce real-time dashboards with unique situational and historical context for different users.”

To improve compliance, contends Vogel, “companies are selecting information technologies that go beyond collection and archiving of data. Today’s manufacturers are looking to information technology to automatically gather required data, drive regulatory compliance, and enforce execution standards while having robust security capabilities. Deploying a Manufacturing Execution System (MES) with advanced information technologies such as these has been proving to be a “plus” to profitability. It greatly increases quality adherence coupled with the ability to shift the production of a single product or a group from under-performing plants to locations that are more advantageous to the bottom line.”

5 of 5 1 | 2 | 3 | 4 | 5 > View on one page
Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.


No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments