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European Pharmaceutical Contractor
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In the 21st Century, everyone operating in pharmaceutical or fine chemical QA/QC should be familiar with laboratory information management systems (LIMS). In pharma and contract research particularly, they are ubiquitous. In R&D, the picture is more complex but they are nevertheless commonplace. The LIMS arena has experienced some headline changes recently and a keen awareness of the implications of these could prove invaluable in assessing both the system and the vendor. These can be summarised as follows:
The use of Internet technologies
Compliance with 21 CFR Part 11 and similar regulatory protocols
Both issues are business pressures; the former is, of course, optional and offers process improvements and efficiencies, while the latter is mandatory.
For many laboratories, the choice is now whether to upgrade or replace legacy LIMS, and also whether to harmonise on a single vendor. There is a bewildering choice of LIMS and LIMS vendors. In addition, many other software systems are capable of implementing functionality traditionally viewed as being within LIMS.
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
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This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
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