Compliance project at Chr. Hansen A/S.
In spring 2011, i2r completed an IT & automation compliance
project for Chr. Hansen A/S.
The assignment was based on a GAP analysis for identification of
improvement needs in GxP critical IT systems for obtaining the
authorities, and customer demands of Compliance in IT and
automation systems with GxP impact.
In collaboration with Chr Hansen i2r has customized a method for
mapping and evaluation of systems and procedures whit GxP impact.
This method provides easy access to the assessment of GxP
compliance and thus identification of GAP's compared to Chr
Hansen's wishes as well as regulatory and customer requirements.
The assignment culminated in a report with proposals for action and
solutions.