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informatics in pharma The right


prescription


Are informatics solutions keeping up with trends in pharma? Beth Harlen speaks to industry figures


Trish Meek, director of product strategy for life sciences at Thermo Fisher Scientific T


he implementation of quality-by- design (QbD) principles by the US Food and Drug administration


has opened the pharmaceutical industry up to the idea that there should be a full understanding of critical process parameters and critical qualities attributes, and that it should be iterative. An outcome of this shiſt has been the interest in paperless lab initiatives. Until recently, there has been the


perception that the cost of integration of a paperless lab outweighed the benefit. Integration technology has now improved to the point where we have direct web service connections between multiple applications that are intelligent bi-directional interfaces that can move data forward, based on reaching stage gates and checkpoints. Pharma is realising that not only are the benefits there, but that connecting a LIMS to SAP QM, for example, is not an enormous undertaking. Te key question is how to take existing


investments – whether that is in LIMS, ELN, SAP QM, etc. – and have an integrated process, from simple instruments through


8 SCIENTIFIC COMPUTING WORLD


to chromatography and mass spectrometry instrumentation, which eliminates the manual steps that introduce risk and the potential for errors. Individual business processes do need to be considered but the fact that vendor-to-vendor solutions exist in the market, and that a custom project is no longer required to connect those interfaces,


THE KEY QUESTION IS


HOW TO TAKE EXISTING INVESTMENTS... AND HAVE AN INTEGRATED PROCESS


is making companies far more receptive. Validation is critical in pharma and when commercially available integration solutions that have been used and tested over multiple sites are an option, that risk goes down. Of course, while this all sounds good in


principle, the biggest stumbling block is that many companies looking at this from an informatics perspective don’t know where their rate-limiting steps are in the process.


What’s surprising is that even if a document exists in an electronic format it can oſten still be physically transferred between departments via paper. Tis is particularly prevalent in pharma due to the fact the industry has historically been resource rich in personnel, which meant there was always someone available to do the manual step and ensure the process felt consistent. Now, however, the industry has been consolidated through acquisitions and mergers, and the number of scientists has significantly reduced in the past 10 years. Tis is manifesting in quality concerns and issues, but, again, informatics can have a fundamental impact. Depending on the company, we have seen an average improvement in performance of between 20 and 30 per cent, purely based on the elimination of manual processes and the review steps associated with them. Te cost reduction immediately justifies the project and the pharma industry is beginning to embrace this – albeit at a slow pace.


@scwmagazine l www.scientific-computing.com


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