Pharma - GxP Order Archive

For the storage of documents of the pharmaceutical and chemical industry there are special requirements which are specified and audited by the responsible institutions such as EMA, BFArm and the German federal and state authorities. In the case of drug approval in other countries, this is done by the relevant authorities such as the FDA in the USA or the MHRA in Great Britain. In addition, there is a multitude of specific legislation and ordinances such as the Medicines Act (AMG), the Medical Devices Act (MPG), the Medicines and Active Substance Production Ordinance (AMWHV) and, finally, the Criminal Code when it comes to the data protection of the volunteers involved.

In the pharmaceutical industry in particular, research and development documents play just as elementary a role as the documentation of clinical studies and batches as well as the manufacturing and approval documents of drugs. This makes it all the more important to store the documents transparently and securely and to guarantee access to them at appropriate service levels - if necessary also around the clock - on the basis of legal requirements and guidelines.