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Taking Control of Change in Artwork and Labelling

Chiara Grimaldi and Stefan Harwart of BearingPoint argue that the right technology streamlines compliance initiatives and boosts operational efficiency

The global nature of pharma has opened its share of doors on both sides of the laboratory. Patients the world over gain access to the best the world has to offer, whilst at the same time the bottom line benefits from a wider distribution net. Everyone’s happy, right?

Distributing cross-border has never been so complex, and with different regional authorities requiring different standards of information delivery, companies find that seemingly benign gaps in communication can give way to painful regulatory pitfalls.

This is particularly relevant to artwork and labelling, for which each country has its own requirements and procedures. There is no central process to guide compliance efforts, and until recently the industry was heavily reliant on paper trails to track marketing materials. This was a tolerable burden when pharma companies were not quite so large and not quite so global. But as the biggest players expanded their networks, the importance of closing gaps has been elevated to the highest level.

As issues with artwork and labelling are identified, companies must take a long look at how they approach changes to the material and resolve these crippling gaps in communication and compliance. Technology advances in data warehousing and change control now make it possible to approach the problem with greater sophistication, yielding greater control and greater return on investment (ROI) for the short- and long-term. Ten years ago, the benefits that are achievable through more streamlined current technology were virtually inconceivable.


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Chiara Grimaldi is a Manager in the European Life Sciences Industry Group at BearingPoint in Germany. She has eight years of professional experience in life sciences, supporting post-merger integration and compliance initiatives across large-scale, complex pharmaceutical organisations. Chiara is a certified eCompliance Manager. She recently supported the European deployment of an electronic repository to establish compliance between pharmaceutical product label text and related production artwork for the EU markets, and the implementation of a change control process to maintain compliance across the European plants and affiliates. Chiara is also highly experienced in programme management, change management, training strategies and preparation of training materials for classroom and e-learning courses, as well as in the rollout of large transformation projects. Chiara graduated in 1998 from the Technical University of Darmstadt in the field of Mathematics, with a concentration on Probability Theory.

Stefan Harwart is a Consultant in the European Life Sciences Industry Group at BearingPoint. He has almost two years of professional experience in life sciences, supporting compliance initiatives and validation projects across large-scale, complex pharmaceutical organisations. He has specific expertise in computer system audits, validation and compliance. Stefan is pursuing his Certified Information System Auditor (CISA) and became a member of the Information Systems Audit and Control Association (ISACA) in 2005. Prior to earning these distinctions and to joining BearingPoint, he worked as a freelancer at Ernst & Young´s Risk Advisory Services department. Stefan studied Business Information Management at the Berufsakademie of Stuttgart and the Royal Melbourne Institute of Technology in Australia, graduating in 2004.

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Chiara Grimaldi
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Stefan Harwart
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