Privatsphäre-Einstellungen

Betrieb von IT-Systemen für die Erstellung von Arzneimittelzulassungen nach eCTD-Standard

Dirk Langenheim

CSC Ploenzke AG, Wiesbaden

Operation of Information Technology Systems to Create Medical Submissions in Accordance with the eCTD Standard

As a consequence of the introduction of the eCTD standard for submitting dossiers, pharmaceutical companies will not be able to do without IT systems in the future. With regard to these systems, it must be considered under cost aspects whether the operation and support of the system will be contracted out to an external provider. However, one must take into account that, due to their relevance for submissions, these systems are subject to the GxP requirements, which means that also the system operation must be validated.
The requirements for validated operation are detailed in the guidelines for inspectors of the PIC/S (Pharmaceutical Inspection Convention / Pharmaceutical Inspection Co-Operation Scheme); Change Management, Security and Audit Trail are the major components affected. In order to optimize the costs for the operation of an IT system it must be checked individually, if both the basic operation as well as the first and second level support can be contracted out to an external provider, or if the use of an ASP solution (Application Service Providing) is an option. All variants must comply with the requirements as to a validated operation.

Key words Arzneimittelzulassung · Application Service Providing · Common Technical Document · Elektronische Zulassung, IT-System, Outsourcing, Validierung, Support