The GxP compliance of Informatics and their services provided for the business is an intensively discussed subject. The fast growing computer technologies are providing headache to both Regulators and the Pharmaceutical Industry on how to meet compliance requirements. The GxP regulations cannot be developed with the same speed as new technologies evolve and are furthermore not providing the detailed guidance needed by the Subject Matter experts. Therefore there are continually discussions internally and during inspections with regard to issues like Cloud Computing, use of Mobile Devices, Data Integrity, Audit Trail Review and SLAs.
For that reason, the “Data Integrity & IT Compliance” Working Group was founded by the ECA Foundation.
Mission of the group is to assemble knowledge on “burning” subjects, like those mentioned above. It is our aim developing best practice guides to help the industry to solve issues in a comprehensive and compliant manner. The group took advantage of the experience and knowledge of its members and the learnings from previous courses and conferences to contribute to the development of a number of papers.
The group’s first project deals with cloud computing. How can economic pressure for introducing cloud computing and potential GMP concerns be brought together? The group will develop a SOP to support you in choosing a cloud service provider. As member of the group you can download and comment the first draft of this SOP.
Board of Directors:
Please find here all
Members of the Authority Board of the ECA Foundation.