The Changing Landscape


The implementation of global standards such as eCTD etc. has substantially changed the way regulated and Corporate Information(Data) Governance and applied Management is handled across business functions.


Regulatory Information Management (RIM, ongoing), properly architected and implemented helped to have, e.g. a better overview of company’s commitments in various regions and countries through regulated content, as well as registration of any type of communication and commitment tracking with Authorities. It spans beyond Regulatory Affairs (RA).

Near Future:

IDMP+ are to be included: Harmonization through the 5 ISO IDMP+ Standards (preferably in conjunction with the ISO ICSR[R3]) will not only meet Regulators request of higher level of content granularity for more effective Information Exchange: Process and data modeling need to move away from point solutions towards an enterprise approach – leveraging Enterprise Assets – about how content of any type can be effectively created, re-used, applied and managed in the future. Business processes are being redefined based on outcome objectives. Solutions are being re-evaluated to achieve a reduction in TCO and to achieve benefits from implementation of these standards internally and with partners.

AND: One important criteria to be included in the above context of Enterprise Information Governance is the move of digital interaction and transaction outside traditional channels. All these conditions have heavily influenced the way we approach our business and achieve our objectives.

Access to current information, what type ever will be crucial for any Enterprise by architecting an Enterprise Repository of content components that can be used in any application and format in communication internally and with the outside world!

Looking at the care and cost intensive hospitals: There is strong need for a transparent, semantically enriched and consistent flow of information: Applying proven semantic technologies.

IDMP+ refers to ISO IDMP, ICSR & SPL Standards