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Quality Management

Electronic Batch Recording for Drugmakers
€ 87.00
net
€ 103.53
Der MwSt.-Satz richtet sich nach der Produktart, auf Print-Produkte werden 7% und auf digitale Produkte 19% berechnet. Bei Bundle-Produkten werden beide Steuersätze berücksichtigt. Vor dem endgültigen Auslösen der Bestellung wird die MwSt. bestellspezifisch angezeigt.
US$
99.00
pdf download
Excerpt from the GMP Compliance Adviser
Edition: First edition, 06/2016
17 Pages
ISBN: 978-3-95807-049-3
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

Data management system concepts for electronic batch recording (EBR) can optimise processes and render them more efficient. Process risks can be reduced preventively and the observance of legal requirements is ensured right up to supporting the pharmaceutical quality system.

EBR systems create relevant documents and records pursuant to the EU-GMP Guide Chapter 4 and they implement the release and certification of batches in accordance with Annex 16. For this purpose, Annex 11 refers to special chapters for electronic batch certification and release.

Introducing and implementing an EBR system requires systematic analysis, definition and assessment of the regulatory requirements, process-based data and product-relevant information. Electronic Batch Recording for Drugmakers gives you the necessary tools and knowledge for a successful introduction and implementation.

You'll get step-by-step guidance through all you need to know about:
  • Regulatory requirements
  • Strategic goals and deployment possibilities of an EBR system
  • System types by extent of automation
  • GMP-relevant functions and properties
  • Collecting and classifying the data
  • Designing an EBR form layout
  • Converting paper documentation to EBR

Order now your copy of Electronic Batch Recording for Drugmakers!

Technical Requirements

This file is in PDF format!
Filesize: 857 KB

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Please note the following procedure guidelines:

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  • You will receive an advance invoice.
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  • The invoice will be sent by postal mail as soon as possible.
  • IT
  • QP
  • QS
Roemer, Markus

Markus Roemer works as an independent consultant at comes compliance in Ravensburg. He is involved in a wide range of areas including the validation of computerised systems, auditing, quality management, project management and compliance management. Since 2008, he has been working as an ISPE ambassador for the DACH affiliate.

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