About the Data Integrity & IT Compliance Group

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, Artificial Intelligence, Data Integrity, Audit Trail (Review) and SLAs.

For that reason, the “Data Integrity & IT Compliance” Working Group was founded by the ECA Foundation.

The Group's mission comprises 2 main areas:

• To influence the development of new regulations by commenting on their drafts
• and 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.

Authority Advisory Board

The Authority Advisory Board is not part of the legal structure. The Advisory Board Members support the Data Integrity & IT Compliance Group on a case by case decision and not for all of its activities. The following Board Members of the ECA Foundation Board support the Data Integrity & IT Compliance Group:

Please find here all Members of the Authority Board of the ECA Foundation.