Building a Smart Laboratory 2018


that may be affected by the new system. It is easy to fall into the trap of just ‘computerising’ an existing laboratory function, rather than looking at the potential benefits of re-engineering a business process. Te use of tools such as 6-Sigma or Lean can help considerably. Nevertheless, it is prudent to be careful with the use of these tools, depending on the nature of the lab. For example, high-throughput, routine-testing laboratories, which basically follow standard operating procedures, are more receptive to process improvement. Discovery/ research laboratories however, which are less structured and are dependent on more diverse and uncontrolled processes, are less likely to benefit from formal process re-engineering. Productivity and business efficiency are


usually measured in financial terms, although this may be translated into time-savings or, in some cases, the numbers of tests, samples, experiments completed. It is necessary, therefore, to be able to quote ‘before and aſter’ figures for any deployment project. Establishing a baseline metric is an important early step in the project. Te tools can facilitate improvement through


well thought-out deployment, but also offer the capability to monitor and improve processes.


Costs/return on investment


Any organisation considering the implementation of a new informatics or automation system will want to investigate the return on investment (ROI), or cost/benefit. Tis is usually extremely difficult, since many of the projected benefits will be based on a certain amount of speculation and faith. However, there are some important points to consider in building the cost/benefit case. Te costs associated with managing paper-based processes (e.g. notebooks, worksheets, etc.) through their full lifecycle in the lab are not always fully visible or understood. Apart from the material costs, and the


costs of the archive process, there is a hidden cost – and the time taken in writing by hand, cutting, pasting, transcribing, and generally manipulating paper, as well as approval and witnessing processes, all contribute to this hidden cost. It is normal in building the cost/ benefit equation to look at how much of a scientist’s time is spent managing the paper- based processes, and to use this as a basis for potential time-savings with an electronic solution (see Figure 6). Although the start-up costs are high for an electronic solution, the incremental cost of adding new users and increasing storage space is modest. ROI tends to focus on the short term: how


soon can one get a return on the money invested in deploying a new system? But the true value of the system may be in the long term and,


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therefore, far more difficult to measure as the value will be determined by behavioural changes. Tere is a growing body of evidence being presented at conferences on electronic laboratory notebooks (ELNs) by numerous companies that have implemented them, showing that the short- term time savings associated with the electronic solution are significant. Tese organisations also


Beyond the laboratory


the evidence – not on the medium that holds the evidence. One important factor is the data integrity, which must be possible to prove in court if necessary. Bound paper logbooks are still being used to a large extent, as most legal advisors don’t feel comfortable with electronic data. It may be smart to talk to patent lawyers before starting to create electronic lab data.


Building a good business case requires a thorough and systematic


approach to understanding current limitations as well as future requirements for the business


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list a number of other non-quantifiable, long- term benefits such as: n Scientists spending more time in the laboratory;


n It is easier to find information in a searchable archive;


n It is easier to share information; n Increased efficiency through the elimination of paper;


n A reduced need to repeat experiments (knowingly or unknowingly);


n Improved data quality; n A smooth transition when people leave the company; and


n Online use in meetings. Regulatory compliance


Te early research phases in the pharmaceutical industry comprises the testing of large numbers of chemicals to see if any of them have potential as a new drug. Only the best will go on to more extensive testing. Tere has been a ‘consensus’ that regulatory work does not start until the chemical has been chosen. Ten adherence to GMP[3] (good manufacturing practice) and GLP[4] (good laboratory practice) starts, and the IT systems need to be in compliance with the local requirements for IT systems. In the US, this is 21 CFR Part 11[5] and in the EU it is GMP Annex 11.[6] While this may be at least partially correct, the fact is that the data, and of course the IT systems that hold the data, need to be under control for another business reason: patents. Te US patent system is based on ‘First to


Invent’, and that means it must be possible to prove the date of the invention. Traditionally, this has been done using bound paper notebooks, where the entries have been dated and signed, and co-signed by a witness. Paper notebooks can be admitted as evidence if they can be demonstrated to be relevant. Electronic records are equally relevant, as the judgment is made on


How can we prove that the IT system is good enough?


Te answer is, of course, validation. Actually, validation of processes is nothing new; that has been a part of the GMP and GLP regimes since they were introduced. An IT system is a part of the process and must therefore be validated as well. Te industry asked the US Food and Drug


Administration (FDA) how it would handle electronic signatures, and accordingly 21 CFR Part 11 saw the light in 1997. Te surprise was that most of the two-page document was about electronic data, and only a little about signatures. Tis, however, does make sense. How can


scientists use an E-signature if they are not sure that the data is (and will be) valid? Tey can’t; they need to have control of your data before they can sign it electronically. Te EU also came up with an equivalent to 21 CFR Part 11, namely the EU GMP Annex 11. Tis was revised in 2011 but does not improve on the first version. But a really good document covering electronic data and signatures is yet another document numbered 11, the PIC/S PI 011.[7]


Tis is a 50-page document


with the same requirements as Part 11, but it includes also a lot of explanations. PIC/S is the organisation for European pharma inspectors. Tey do stress that this document is not a regulatory requirement, only an explanation to the inspectors on how to handle IT systems. How that cannot be a requirement document, is hard to understand, however. Te main difference between Part 11 and Annex 11 is that the latter also includes risks. IT validation shall be based on risks; high-risk systems need more validation than low-risk systems.[8] Tis follows the same line of thought that


the FDA started in the early 2000s: know your processes, and base the work on the risks they encompass.


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