Beyond the laboratory Building a Smart Laboratory 2017

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, 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 list a number of other non-quantifiable, long-term

benefits such as: l Scientists spending more time in the laboratory;

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

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

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

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

l 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] EU it is GMP Annex 11.[6]

and in the 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 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

Fig. 6: System costs of paper notebooks and ELNs Paper Electronic Cost Elements

Media Storage

Management process 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 the evidence – not on the medium

“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, therefore, far more difficult to measure as the value will be determined by behavioural changes”

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.

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

Number of users

System cost

Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44