arvato services healthcare fulfills all applicable pharmaceutical guidelines in the IT environment. The IT systems that are deployed depend on the customer-end infrastructure and individual project requirements.

For the first customer with GxP requirements in 2002, for example, the existing SAP system was validated retrospectively, while all other clients since that time have been validated prospectively and concurrently to the project. The following specific guidelines were applied:

• 21 CFR Part 11 (electronic records, electronic signatures) 
• 21 CFR Part 211 (cGMPs for pharmaceuticals) 
• EC Guideline of Good Manufacturing Practice (including the
  16 supplement guidelines, in particular number
  11 for computerized systems) 
• Guide to Inspection of Computerized Systems in
  Drug Processing, FDA 
• Software Development Activities, Reference Materials
  and Training Aids for Investigators, FDA 
• General Principles of Software Validation, FDA 
• PIC/S PI 011-1

High system stability through redundancy

System stability through hardware redundancy is the top priority when hosting. The use of shadow databases with an (intentional) time lag is effective in dealing with even logical errors. A physically separate backup computer center protects against the loss of the main computer center if a catastrophe strikes.

The system is backed up at least hourly and when the each tape is full. Backup tapes are moved into the secure bunker attached to the computer center as quickly as possible. The entire computer center is equipped with access protection, including single-person gates, and accessible only to selected, authorized personnel. The computer center is certified according to various recognized standards.

Individuality through a client concept

arvato services healthcare uses a client concept that makes it possible to run each individual client’s processes and developments privately and securely. Standard interfaces allow quick integration of any external system. A browser-based front-end solution ensures optimal user navigation and ease of use.

The client is guaranteed routine, detailed reporting.  In many cases, data updates can be output daily. arvato generally coordinates the precise content of the customized reporting with the client before the order is executed.