Selecting and Implementing Electronic Document Management Systems in the EU
Converting to an electronic document management system (eDMS) is key to increasing your record-keeping efficiency. Only one resource enables you to do that in a cost-effective manner while ensuring compliance with EU regulations: Selecting and Implementing Electronic Document Management Systems in the EU.
Unless you have a robust IT department, the prospect of making the transition from paper to eDMS is daunting: you have to learn new terms and concepts, identify user needs, select a vendor or developer and train employees. All while keeping costs under control.
This management report explains everything you must know to select, develop, implement, integrate and train on an eDMS that is right for your organization.
It walks you through the transition process and ensures compliance with EU regulations that are likely unfamiliar, including Volume 4 of the EU Good Manufacturing Practice (GMP) guidelines and Annex 11 (computerized systems). These are combined with the principles found in the Good Automated Manufacturing Practice (GAMP) guidelines, walking you through every step of establishing a robust, compliant eDMS.
You’ll 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.
It shows you how to integrate your new eDMS with your other electronic systems, as well as restrict access and ensure data security, and handle system hardware installation and maintenance.
This report gives you a top-to-bottom view of the eDMS transition process and empowers you to implement your new, EU-compliant system efficiently.
- 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.
About the Contributor
Thilo Gukelberger is a business IT specialist at d.velop Life Sciences in Gescher, Germany, where he has been managing the life sciences division since 2007. He is responsible for the strategic approach for GxP-related software products and quality management solutions, having managed many projects involving the introduction of IT systems in the pharmaceutical sector.
Who Will Benefit
- Document management staff
- IT support staff
- Quality management staff
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