| Business pressures are forcing the pharmaceutical industry to reduce costs and improve efficiency. Analytical laboratories both in R&D and manufacturing are one of the rate limiting areas where often the business is waiting on the analytical results before making a decision on what to do next or release a product. Efficiency improvements are clearly and urgently required but how should a laboratory plan to achieve them?
The electronic laboratory has been a dream for a number of years. Now we have the regulations in 21 CFR 11 in the US and the 2011 version of GMP Annex 11 in Europe that allow us to work electronically and sign records with electronic signatures. There are many applications and automated systems available that can be implemented and integrated to make the laboratory electronic. The problem is that do laboratories have the vision to do this? Many laboratories have major scientific applications such as LIMS, electronic laboratory notebooks and chromatography data systems but are they interfaced by paper and manual data input.
The aim of this short course is to help attendees design an electronic environment that provides business improvements and regulatory compliance for laboratories in the pharmaceutical and allied industries.
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