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European Biopharmaceutical Review

In with the New


Several labs have made significant investments in technologies and solutions to help optimise their business processes, yet many have not reaped the return on investment they planned. A paperless lab can improve efficiency, compliance and quality by integrating data silos and automating laboratory operations.

A paperless lab integrates the laboratory with the enterprise and automates systems by eliminating paper-based, manual and error-prone processes. While most companies have invested in many instruments and software solutions in the laboratory and manufacturing to improve operations, these systems are not seamlessly integrated, creating data silos, or standalone information repositories that do not communicate with one another. By automating operations and integrating these individual solutions, organisations can reduce paperwork, increase efficiency and throughput, automate regulatory compliance, reduce costs, foster collaboration and make faster, better informed business decisions.

What’s Wrong with Paper?

The benefits of using paper are evident. It’s easy to use, convenient, portable and legally defensible; plus, it requires little (or no) user training and supports multiple data types. Unfortunately, paper also has some major drawbacks. It introduces security risks, it’s expensive, it’s not searchable, it’s not collaborative, there are significant storage issues and, perhaps most importantly, it’s error prone and susceptible to transcription mistakes. In any process, the handling of paper is almost always a manual (human) activity. And manual activity is inherently prone to errors. At the very best, for every 1,000 results transcribed from an instrument, the human will make, on average, three to six mistakes. Typical error rates increase to three per 100 transcribed results (or 30 errors for every 1,000 results) if any calculations or stress are involved. In addition, large volumes of paper-based data are difficult to store and practically impossible to search at a later date.

Just How Costly are Manual Errors?

Imagine, for example, that you have seven people in your lab spending 20 per cent of their time annually writing documents. This involves documenting lab tasks (writing documents to communicate results or reviewing documentation), and every one of these activities must be logged and, in some cases, approved by another person. If those efforts could be reduced by 10 per cent, this translates to putting 336 hours, or 42 days, back into doing more productive and meaningful work. If those same efforts were cut by 20 per cent, a lab could create 672 hours (84 days) and earn cost savings of $154,000 per year.

Imagine what could be done if the amount of time employees spend manually collating reports, preparing samples, performing calculations, and so on was reduced. What could companies do with savings potential like this? Scientists and lab personnel would be able to spend more time on value-added activities that generate revenue.

Why are Customers Looking for a Paperless Lab Now?

None of this is new information. Companies have always recognised the potential benefit of integration across the enterprise, but they’ve been too busy focusing on other priorities. It wasn’t until recently, in a continuing effort to reduce costs, that companies have turned their attention to automating laboratory processes and/or instrumentation and integrating that data with existing ERP, LIMS, ELN and CDS systems, among others.

The problem is that these tools and technologies are, if left unconnected, accessed separately, creating islands of information. Compiling data from multiple systems is laborious, and users will often resort to spreadsheets in order to access the data they need. Data is disaggregated across the organisation, both internally (R&D, manufacturing, geographically, functionally and so on) and externally (contract companies, suppliers, research institutes). To exacerbate the problem, new solutions (tablets and mobile devices) further complicate the integration issue.

Keeping these systems separate fails to maximise investment and introduces unnecessary inefficiencies and errors. In addition to not achieving expected ROI, users may not be able to find the information needed or view data in a way that enables fast and informed decisions. What is the end result? Companies are left with significant exposure, from compromised product quality to delayed decision making to releasing bad products into the market.

How Should You Select a Paperless Lab Solution?

When considering your options for creating a tightly-integrated paperless lab, it’s important to look for an offering that combines a solid methodology for analysing existing workflows, state of the art technology to move lab operations to optimum efficiency, and comprehensive services to implement the paperless lab and support the company’s ongoing needs.

Implementing any solution should begin with a methodology – a comprehensive consultation to assess the organisation’s existing laboratory automation, instrument integration and workflow. The assessment should highlight potential ROI and operational gains, and deliver a plan for addressing where current workflow relies on human intervention (often the cause of bottlenecks or errors).

On the technology front, the offering selected should make the most of the organisation’s existing investments, even if they’ve been purchased from a variety of commercial vendors. The ideal solution should integrate instruments and equipment, connecting data sources with data destinations via a single interface. State of the art integration middleware can translate disparate instrument languages and convert raw data to a vendor-neutral storage format for data archiving. In keeping pace with technology advancements in and out of the laboratory environment, any investment in a paperless lab solution should be able to offer access to raw data and instruments from any web browser or mobile device. And last but not least, the solution provider should offer pre-and post-implementation consultative services to ensure the paperless environment is continuously optimised as the lab environment changes or as business needs require.

The Paperless Lab in Action

While many technologies come together in a successful paperless lab, the lynchpin in going paperless is a laboratory information management system (LIMS). LIMS solutions are now able to fully integrate even the most heterogeneous labs. This is an important landmark because the broad spectrum of vendors has been the perceived (and sometimes practical) obstacle for fully integrating the lab in the past. With today’s LIMS solutions, the cost to integrate different software systems and equipment from independent instrument vendors is no longer prohibitively high.

In fact, some LIMS solutions go beyond transforming data from any instrument and delivering it to any source, taking the opportunity further by enabling scientists to see their real analytical data, chromatograms, mass spectra and results from other instrumentation regardless of the instrument supplier. This type of automated data acquisition and point-to- point data distribution across the enterprise is the true key to enabling today’s paperless lab.

The response to paperless lab offerings among pharmaceutical companies has been overwhelmingly positive. More and more, life science industries want to get to a paperless lab: it is ultimately a customer-driven initiative, and many labs have finally reached the point where they see the value in going completely paperless. Competitive pharmaceutical companies understand the value proposition inherent in measuring the success of every minute of research and scientific progress. In industries such as oil and gas, paperless testing laboratories are already the norm – production efficiencies and enhanced regulatory abilities offer a competitive advantage to those companies willing to go paperless – and it is not hard to foresee the day when the same is true in life sciences. The paperless lab is the lab of the future, and LIMS is the technology that will make that future possible.

Conclusion

If a company has made significant investments in enterprise and laboratory tools, technologies and solutions but isn’t reaping the ROI or seeing the improvements in productivity, efficiencies and data management that such investments promised, the paperless lab concept deserves serious consideration. Not only can such an integrated, seamless environment improve compliance and quality by eliminating data silos and connecting islands of information across the enterprise, but it can free up your scientists and laboratory professionals to spend more time on value-added research, new product development or other activities that bring revenue to the business.

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Susan Najjar is the Director of Marketing for the Informatics business at Thermo Fisher Scientific. She joined the organisation seven years ago and manages the global marketing activities for the Informatics software business. Prior to joining Thermo Fisher, Susan had worked at Proctor & Gamble, Oracle, Deloitte & Touche and Polaroid Corporation. She attended MIT Sloan School and holds an MSc in BioChemical Engineering from Tufts University.
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