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Electronic Document Management Systems for Drugmakers

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Product Details

Converting a paper-based documentation system into an electronic document management system (eDMS) is a win-win for drug manufacturers, the FDA and the EU.

But difficulties lie in the complexity of converting from paper to electronic: the selection, design, implementation and validation of your plan.

Electronic Document Management Systems for Drugmakers, a new management report from FDAnews, tackles all those difficulties — the key concepts, various issues and tricky interrelationships with other systems — that you must deal with during a conversion to a validated eDMS.

With the help of expert author Markus Roemer, you'll dig into how to begin making changes to your company's documentation management — including both knowledge and information management — as well as to documents and records relating to SOP management, training management, changes, deviations, production and warehouse records , records from the laboratory sector, and more.

And, you'll begin to see how a paper-to-electronic conversion will completely change — and simplify — your existing procedures, processes and how you handle all your information and data.

Specifically, you will learn:

  • How to convert a paper-based documentation system into an eDMS
  • The basic principles and functions of the eDMS — and what technical aspects to be concerned about
  • How to handle project management, validation and system selection when an eDMS is implemented
  • The links between document management and information and knowledge management
  • Regulatory requirements to consider when an eDMS is implemented
  • Why training management or other quality-relevant processes should be taken into account in an eDMS
  • How to define 'the master document'
  • What to think about in determining electronic data and electronic signatures

Completing a paper-to-electronic conversion is a complex undertaking. Let an acknowledged expert give you assistance, right from the beginning. Order your copy of Electronic Document Management Systems for Drugmakers today.

Meet the Author

Markus Roemer is an independent consultant and auditor with Comes Compliance Services in Germany. He has worked as a quality project manager for GMP projects, electronic batch recording systems, quality release management and application development, and auditing for Propack Data GmbH – Rockwell Automation.

He has also served as director of compliance management at Systec & Services and senior validation consultant for Invensys Validation Technologies.

He is a founder and member of IT Pharma Validation Europe and ambassador for Germany, Austria and Switzerland at the International Society of Pharmaceutical Engineering (ISPE).

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Table of Contents

  • About the Author
  • Introduction
  • Documentation and Document Management
  • And More …

View the entire TOC

Who Will Benefit

  • Executive management
  • Data management and statistics personnel
  • IT managers
  • Manufacturing directors and supervisors
  • Quality managers
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • General/corporate counsel

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