Regulated Document Management – an integral part of a World Class RIM

2016 十二月 20

3:00 PM London / 4:00 PM Berlin / 10:00 AM New York

The majority of currently used Document Management Systems is fossilized in many companies while the need for integral companies’ business processes increased. Join us to learn about the next generation of Regulatory Document Management.

The majority of currently used Document Management Systems is fossilized in many companies while the need for integral companies’ business processes increased. The next generation of DMS builds integral processes around products, not documents leveraging product data. Document Management needs to be part of an Integral Regulatory and Quality Information Management solution that supports Marketing Authorizations and orchestrated by easy to apply Change Controls on any level, enabling self-validation of the system.

The border between document, submission, and data management is disappearing due to the granularity of content and data that is required by authorities. Local needs in global context involves local affiliates as an integral part of global processes. Governance of content and data in such environment can no longer be managed by traditional tools. Integral DMS builds the foundation for a new generation RIM (as described by GENS), offering object oriented approach, not only for Document Management, but also for Interfaces with other systems like RIMS, XEVMPD/IDMP, Publishing, ERP/SAP and MDM among others.

It enables management of content and documents in preconfigured granularity in context of product data, which can be exchanged with such systems. Every document and every synchronization object has its regulatory history, allowing impact assessment in local and global context and automation of document creation and processing. In addition, the Integral DMS will reduce the upgrade and validation effort dramatically.

There are alternatives available in the market to help you overcome your Regulatory challenges: AMPLEXOR Life Sciences Suite - the market leader in Medicinal Product information.

Are you tired of:

  • Separated docbases for R&D, TMF and Quality?
  • A slow and old fashioned, or simplistic and unsophisticated user interfaces?
  • Costly upgrades with every new version of your tool?
  • High number of limited functionality interfaces to other systems?
  • Redundancy of data, documents and data entry?
  • Missing link to products and regulatory processes

Key Learning Objectives

  • Recognize the value and business potential of the next generation of integral DMS
  • Understand the difference between traditional systems like FirstDoc, Score, Vault, D2 and the new integral DMS
  • Follow the standardized migration approach from legacy DMS to the next generation
  • Create your own assessment and discover which deployment model, on- or off-premises, is the best for you

Presented by

Romuald Braun, VP Strategy, Life Sciences

Since 1992 Romuald has been working in roles related to Compliance, Document Management, Content Management in the Life Sciences industry. Romuald has been playing roles on the client side and in consulting, in delivery and in sales, in project roles and in line responsibility. He worked in client server and in cloud environments, in Europe and in US.

Romuald is holding the academic degree of Master of Drug Regulatory Affairs in addition to his Engineer diploma in Data Technology. Romuald has been also a frequent speaker on topics relating to content management adoption in life sciences.

Sinisa Belina, Senior Life Sciences Consultant

Sinisa started his professional career at Pliva (now member of the TEVA Group), where in addition to his responsibilities in manufacturing, he also engaged in successful EDMS implementation project. Belina later joined KRKA’s Regulatory Affairs Department, and finally moved to AMPLEXOR. He applies his detailed knowledge of pharmaceutical documentation and processes to areas of business process analysis and optimization of EDMS.