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PhM’s virtual panel weighs in on information technology trends in pharmaceutical manufacturing

By Steven E. Kuehn, Editor in Chief

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Cloud offerings are beginning to be considered and, even with Pharma’s overwhelming intellectual property and security concerns, some applications will be appropriate for the cloud and allow for faster deployment and greater access. Software offerings requiring extensive validation may not yet be ready for cloud deployment but that problem is being working on by a number of vendors. The bottom line is that, both from the vendor side and the greater acceptance of electronic solutions by regulatory agencies, the move to the electronic solutions is not an ‘if’ but a ‘when’ and many of those regulatory bodies will start dictating timelines. The time is now.”

PhM: Improvements in the Pharma industry tend to revolve around five key areas:
• Assuring product quality/patient safety
• Driving out cost
• Accelerating time to market
• Reducing risk
• Improving compliance

How can information technologies best be deployed to improve on these imperatives?

K.R. Karu, Sparta Systems Inc.: “Progressive companies that have implemented enterprise-wide harmonized systems for managing quality processes have found measurable improvements in all five areas listed above. When global processes and data capture are in place for auditing, issue investigation and resolution, CAPA management and change management; problems are discovered and remediated earlier in the manufacturing process which makes for a better and safer product released to market. The earlier a problem is discovered and resolved, the less it costs, which ultimately reduces all manufacturing costs and reduces shortages. If lessons learned in one area can be applied to many, this creates further efficiencies and helps produce more ‘first time right’ which reduces risk and accelerates time to market. Having global systems in place that are proven to produce these results always improves compliance with regulations.”

Ken Rapp, Accelrys: “We believe the key to improving these five areas is standardization. By employing the best practices of the industry — the ‘tried and true’ automated processes that have proved they provide value — the cost of ownership decreases dramatically while the time to value increases dramatically. We like to think of these automated solutions are to IT what Betty Crocker cake mix was to baking. Just add eggs and water, and you’re guaranteed an excellent cake every time without the fuss of the gathering and measuring various ingredients and going through tedious preparations. In the same way, the best practices of lab automation make experimentation more efficient, driving costs down, improving product quality, accelerating time to market, reducing risk and improving compliance.”

Dino Busalachi, Applied Group: “Concerns around product quality, cost reductions, improved profitability, risk reduction and compliance improvements — those frankly are what drive our conversations with our customers. Within the manufacturing side of our business, that is, our automation practice, we have a heavy focus on OEE [overall equipment effectiveness]. There’s the famous quote from management consultant and author Dr. H.J. Herrington, ‘Measurement is the first step that leads to control and eventually to improvement. If you can’t measure something, you can’t understand it. If you don’t understand it, you can’t control it. If you can’t control it, you can’t improve it.’ From our perspective, it’s all about OEE and it’s all about improvement and it’s all about real time contextual intelligence.

Trending is a big piece of OEE; for example, we can measure output from sensors on specific devices in a manufacturing operation, and look at how that particular sensor performs for given a period of time, enabling preventative maintenance on a cell line. But the possibilities are limitless. People can do a lot of things with information that leads to improved quality and operational efficiency — decision support in real time. You can’t pursue your business goals if you don’t manage your assets effectively and understand what’s happening in real-time. With access to real-time manufacturing/operational intelligence, you gain the ability to manage forward, versus managing from a rear-view mirror.”

Trish Meek, Thermo Fisher Scientific: “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. 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.

Today’s LIMS is far more than just a lab information system. It is also a laboratory resource planning system. 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 capabilities of the latest Informatics solutions are capable of fully integrating the laboratory, 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.

In addition to taking advantage of the latest LIMS functionality, we also find that integration and data visualization are key components in our customers’ paperless lab strategies. Data visualization takes integration to the next level. The ability to see not just the final result number, but the actual chromatographic or spectral data gives scientists the ability to quickly identify if a result is a bad sample or a bad run. This enables them to quickly escalate problems with a batch or an environmental contaminant or retest the sample as a priority sample and approve the batch.”
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