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Tuesday, December 12, 2006

Danish business solution for the medico industry

Danish Axatech has recently presented GMP Business Suite which is the world’s first fully digital business solution for the pharma and medico industries.

All over the world, the whole sector of drug, biotech and medico companies share one word: control. This is due to the fact that the American Food and Drug Administration, FDA, has set up a number of regulation requirements with regards to the kind of documents the so-called regulatory industry is to fill in to be able to export to the USA, writes idag.

Documentation equals control and therefore every little routine or procedure need to be described in details all through the production process. If even the slightest deviation takes place from what you say you do in the process compared with what is actually done, then FDA requires that the production is to stop with the result that tremendous losses will occur for the company.

Danish Axatech is now remedying this by launching a GMP Business Suite which is the first pre-validated business solution where both FDA regulations, documentation requirements from European Medicines Agency and the industry’s GAMP4 directions can be complied with and be digitally documented.

GMP, Good Manufacturing Practice, Business Suite is based on Microsoft Dynamics AX for Life Sciences which is a tailormade ERP and business solution for companies within Life Sciences, food, pharma, medico and drug industries. Altogether the two tools are a real breakthrough for a one hundred per cent digital production and validation process.



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