Document and data archiving

All types of documents, master documents and those related to processes, plants and devices, must be either in digital form or paper-based and must be defined and conform to regulatory requirements. In this context, the specified life cycle and the up-to-dateness of the documents are of particular importance.


Appropriate controls must be implemented to ensure the integrity, up-to-dateness and readability of documents throughout the retention period. Archiving the original historical data (“master records”) is common practice to permanently preserve records in order to protect them from changes.


In the pharmaceutical environment, archiving of documents is regulated and governed by § 20 AMWHV (Arzneimittel- und Wirkstoffherstellungsverordnung, German Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients,). For advanced therapy medicinal products (ATMPs), a retention period of 30 years is applicable. It must be ensured that all records are available for inspection by the relevant authorities during regular business hours or can be made available in a timely manner. The archive must be spatially arranged in such a way that unauthorized access to the stored records is prevented and stored material is protected from environmental influences and premature destruction.

It is obvious that a large amount of documentation can accumulate in 30 years. Certified companies can take over the storage as well as the necessary short-term provision. Our experts from Valicare support you in generating and implementing specific archiving concepts.