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FDAnews Announces Selecting and Implementing Electronic Document Management Systems in the EU Management Report

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FALLS CHURCH, Va. (PRWEB)

Selecting and Implementing Electronic Document Management Systems in the EU https://www.fdanews.com/products/62138

Transitioning to an electronic document management system (eDMS) can be intimidating, but as drug and device manufacturers transition to an eDMS, their efficiency is increasing.

The Selecting and Implementing Electronic Document Management Systems in the EU management report explains everything needed to select, develop, implement, integrate, and train on an eDMS that is right for drug and device manufacturers. The report willwalk readers through the transition process and ensure- compliance with EU regulations that are likely unfamiliar, including Chapter 4 of the EU Good Manufacturing Practice (GMP) guidelines and Annex 11 (Computerized Systems).

Readers will understand the types of records best suited to an eDMS, how an electronic system functions, its benefits, how to determine user needs and get user buy-in, system validation requirements, advantages of cloud vs. local storage, and how to evaluate potential vendors.

In addition, the report will show readers how to integrate new eDMS with other electronic systems, as well as restrict access and ensure data security, and handle system hardware installation and maintenance.

This report gives a top-to-bottom view of the eDMS transition process to empower drug and device professionals to implement new, EU-compliant system efficiently by clarifying:

  • Definitions of electronic document system terms, such as metadata, dossier, living vs. static documents and much more

  • Time expenditure for authoring, review, release and distribution

  • Usability of documents in work processes

  • How to establish tamper-proof security

  • How to manage electronic signatures and audit trails

  • Ways to integrate an eDMS with other systems


A compliant and effective eDMS begins with Selecting and Implementing Electronic Document Management Systems in the EU.

Management Report Details

Selecting and Implementing Electronic Document Management Systems in the EU

https://www.fdanews.com/products/62138

Price:

$197

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Online: https://www.fdanews.com/products/62138

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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