EDMS Typical Systems
eSubmission Ready Document Management
SOP Management
electronic Trial Master File
Capa & Deviation Management
Records Management / Archiving
Pharmacovigilance Document Management
Labelling Systems
CMC Batch Records Archive


e-DRA Project References
Write User Requirements, select and implement an EDMS and Deviation / CAPA system (Biotech Company)
Write User Requirements and select cloud EDMS vendor (Biotech Company)
Write User Requirements for global eSubmission Ready document management system (Top 20 Pharma)
Write User Requirements for EU Clinical Document Management System (Top 20 Pharma)
Analyse EU processes / provide input to user requirements  for Global Pharmacovigilance EMDS (Top 20 Pharma)
Assess if US eTMF system can be implemented in European organisation (Top 20 Pharma) 
Write User Requirements for corporate EDMS (Mid-size Pharma)


Publications
Document Management in Pharma R&D
, DIA Today 2007, Volume 7 Issue 1: 22- 23, Harmsen S.
R&D organisations produce, deliver and receive an increasing amount of electronic documents, reports, dossiers, emails, letters, faxes etc. In recent years they have heavily invested in Electronic Document Management Systems (EDMS). eCTD has rationalized the submission of dossiers to authorities. Still, document management remains to be a business critical issue which is not solved in an efficient way. What actions should R&D organisations take in order to meet those growing document management demands? The author Sven Harmsen discusses how R&D organisations can control the flood of documents, streamline the authoring process and reduce the number of documents. This article is based on his experience made in a European business unit of a global R&D organisation

Electronic Document Management in Clinical Research, Pharmind 2007; 70, Harmsen S.
In this article the author Sven Harmsen describes how the usage of IT systems can help to manage documents in clinical research. He shows efficient ways to prepare the documents, to manage Trial Master Files (TMF) and Clinical Trial Authorisation (CTA) packages and to capture knowledge contained in clinical research documents. The article is based on the experiences made in a European business unit of a global R&D organisation. In addition procedures and ideas from other biopharmaceutical companies were taken up. The aim of the author was to illustrate “best practices” in the area of document management in clinical research.


Presentations
eDMS in the cloud – lessons learned of a biotech company
28th - 30th November 2012 - 13th DIA Conference on European Electronic Document Management, Munich
More info at: http://www.diahome.org

Dokumentenmanagement für Regulatory Affairs
Wíntersemester 2009 - 2012, Universität Bonn - Master of Drug Regulatory Affairs
Weitere Informationen unter http://www.dgra.de

Elektronisches Dokumentenmanagement zwischen F&E und Zulassung
2009 - 2011, Forum
- Typische Dokumentenmanagementprobleme im Pharma- / Biotechunternehmen
- Gesetzlichen Anforderungen an das Dokumentenmanagement (Europa, USA)
- Dokumentenlifeycle: Vom Entwurf bis zur elektronischen Unterschrift
- Elektronisches Dokumentenmanagement System (eDMS): Einführung und Validierung
- Abteilungsübergreifende DMS-Lösungen
Weitere Informationen unter http://www.forum-institut.de

Regulatory (Clinical) Document Management - all the eSystems you need
13. April  2010, Istanbul, eCTD, current status and applications in the world & Turkey
More info at http://www.mkistanbul.com

eSubmission Dokumenten Management für Regulatory Affairs in einem multinationalen Unternehmen

27. / 28. Mai 2008, Frankfurt-Eschborn - 1. DGRA-School Elektronische Zulassung
Weitere Informationen unter http://www.dgra.de

Document Chain Management in Pharma R&D
March, 2007, Vienna, 19th Annual EuroMeeting, DIA
Session Lead 
More info at: http://www.diahome.org