Added value for pharmaceutical companies with Cloud solutions validated according to EU GxP Annex 11

12 October 2016

Pharmaceutical companies often have to share sensitive data such as scans, diagnoses, patient data, etc. with their partners when it comes to clinical research, scientific documentation or medical information. Standard tools such as email, FTP services, download links or USB flash drives do not meet the high requirements that apply to data protection, security and compliance in the pharmaceutical sector. In addition, productivity constantly needs to be increased while costs must be reduced. This development has led to the demand for tools to share content in a collaborative and mobile environment between researchers, health experts, patients and other partners, to edit that content in real-time and to automate workflows.

The Fabasoft Cloud meets these requirements with a wide range of functions included in the standard version and validated according to EU GxP Annex 11. Customers can adapt the Cloud to their individual needs quickly and by themselves. Pharmaceutical companies are using the Fabasoft Cloud to safely synchronise, share and commonly edit documents with all persons involved in a project. Processes such as releasing a clinical study are easy to manage and can also be effected in a mobile environment. The entire handling of data is fully documented in a revision-safe way. In August 2016, the validation of the Fabasoft Cloud according to EU GxP Annex 11 certified that the products and services of the Fabasoft Cloud meet all requirements that apply to regulated industries with regard to quality management systems, IT service management systems and IT security management. This equally pertains to the processes for the development of the software as well as to the processes for the distribution of a Private Cloud in the case of an “Saas“ (Software as a Service) model.

Whitepaper “Secure and traceable sharing of documents & workflow management in the Cloud for pharmaceutical companies”

Pharmaceutical companies can only implement Cloud solutions that have been validated according to strict compliance guidelines. It therefore saves time as well as money if the Cloud solution has already been certified. Based on the example of the Fabasoft Cloud , the following Whitepaper outlines the requirements on a Cloud solution for the pharmaceutical industry, and compares EU GxP Annex 11 with FDA 21 CFR Part 11.