FDAnews Announces Selection and Implementation of Electronic Document Management Systems in EU Management Report

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Overwhelmed by the transition to an electronic document management system? Ensure a hassle-free conversion, in accordance with the EU.

FALLS CHURCH, Va., April 18, 2022 /PRNewswire-PRWeb/ — Selection and Implementation of Electronic Document Management Systems in the EU https://www.fdanews.com/products/62138

The transition to an electronic document management system (eDMS) can be daunting, but as drug and device manufacturers move to an eDMS, their efficiency increases.

The Management Report on Selecting and Implementing Electronic Document Management Systems in the EU explains everything needed to select, develop, implement, integrate and train on an eDMS suitable for drug manufacturers and of devices. The report will guide readers through the transition process and ensure compliance with European regulations that are likely to be unfamiliar, including Chapter 4 of the European Good Manufacturing Practices (GMP) Directives and Annex 11 (Computerized Systems ).

Readers will understand the types of records best suited for an eDMS, how an electronic system works, its benefits, how to determine user needs and gain buy-in, system validation requirements, the benefits of cloud versus to local storage and how to assess potential sellers.

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

This report provides an overview of the process of transitioning to eDMS to enable medicine and device professionals to effectively implement a new EU-compliant system by clarifying:

  • Definitions of electronic document system terms, such as metadata, record, live or static documents and much more

  • Expenditure of time for creation, revision, publication and distribution

  • Ease of using 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 starts with the selection and implementation of electronic document management systems in the EU.

Details of the management report
Selection and implementation of electronic document management systems in the EU
https://www.fdanews.com/products/62138

Price:
$197

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In line: 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 European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay compliant with international standards and complex and ever-changing FDA regulations.

Media Contact

Michael ButlerFDAnews, 703-538-7665, [email protected]

SOURCEFDA news


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