There are special requirements for storing documents for the pharmaceutical and chemical industries – and they are set and audited by the responsible institutions like the EMEA (European Medicines Agency), BfArM (Federal Institute for Drugs and Medical Devices) and the German federal and state authorities. If a drug is certified in other countries, this takes place through the relevant authorities like the FDA in the USA or the MHRA in Great Britain. Then there are a number of specific relevant laws and regulations like the German Medical Preparations Act (AMG), the German Medical Products Act (MPG), the German Order for Manufacturing Medicinal Products and Active Pharmaceutical Ingredients (AMWHV); and finally the German Criminal Code, when dealing with data protection for any test persons used.
Research and development documents, documentation on clinical studies and batches and the production and certification documents for drugs all play a crucial role, particularly in the pharmaceutical sector. So it is all the more important to store the documents in a transparent and safe way and guarantee access based on legal regulations and guidelines in line with suitable service levels, 24 hours a day if necessary.
We offer our pharmaceutical customers the option of archiving their documents in a high-security archive in line with the principles of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). We obtained the GLP certificates for several of our high-security archives from the relevant state authorities in mid-2011. This certification makes it easier for our customers to include us in their manufacturing permit and commission services based on an agreement clearly defining the roles of the customer and the service provider. Our project management team has experience in developing individual archive Standard Operating Procedures (SOP) and is more than willing to help.
Rhenus Office Systems has its own business continuity management system and is therefore able to respond in an appropriate and structured manner in emergency situations or if a hazard occurs. Rules for maintaining core processes have been developed for each business centre and they guarantee a return to normal operating conditions as quickly and smoothly as possible. This provides guarantees for our customers that the documents stored are available in any situation.