Document Management & Archiving for the Healthcare and Pharmaceutical Industry

Within the Rhenus Group Rhenus Office Systems offers a broad range of archiving services for the Healthcare and Pharmaceutical Industry.

Governmental Regulations

The preservation of items originated from the pharmaceutical industry, such as documents, raw data, sample material, specimens, retention and reference samples, compels businesses to comply with special requirements given by public regulatory authorities like the US Food and Drug Administration (FDA) or European Medicine Agency (EMA). According to the context in which a preservation item was created, different specifications apply, the most important being Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), often summarized as GxP, the Good Practices.

These regulations often apply to all phases of the sample life cycle, beginning seamlessly with the removal from the customer’s storage and including maintenance and monitoring of specified storage conditions as well as long-term quality assurance. Ending with the professional destruction and disposal within the Rhenus Group in strict compliance with statutory regulations.

Our Logistic Solutions

Rhenus offers its customers GxP-compliant, temperature-controlled and -monitored archiving solutions for their resulting from diagnostics or (pre-) clinical research, in addition to their study and product licensing records. In the case of worldwide deliveries by CROs (Contract/Clinical Research Organizations) or clinical investigators, Rhenus’ services begin before takeover of the items by organizing professional transport, required import permits and transfer agreements.

Each preservation item – sample or file – is bar-coded at the time of takeover from the customer’s stock and captured in Rhenus’ archiving system, as required by the customer for example on study base. Each movement of an item including destruction is documented in the archiving system. Rhenus’ online portal, via which customers can request retrieval of preservation items, provides an all-time transparent overview of stocks which may include:

• Wet tissues, that is preclinical organic material that has undergone fixation
• Paraffin blocks, microscope slides and x-ray images
• Sample material and reference samples to be preserved isothermally, e.g. at -20°C or -80°C
• Retention samples and active substances, e.g. with temperature-controlled stability testing between 5°C and 40°C
• Electronic raw data in the shape of data carriers or digital data for long-term archiving
• Documents, e.g. from research or manufacturing and potentially subject to GxP

As documentation from research, manufacturing and clinical trials fulfills an essential role in the pharmaceutical industry, for example as prerequisite to gain and retain approval, it is vital to store these safe but easily accessible to satisfy regulatory authorities’ needs. To establish individual solutions for archiving of pharmaceutical documents Rhenus is able to customize standard operating procedures (SOPs) for each customer.