GMP aspects of EBR l BatchLine Resources

GMP aspects of Electronic Batch Recording - Part 3: Managing Master Data

5/13/2020

This article is the third part of a series based on applying the new GAMP GPG Data Integrity - Manufacturing Records
Continuing our article on the GMP aspects of Electronic Batch Records (EBR) we look into a set of questions about controlling Master Recipe, Material Control, Equipment Control and Users
Based on GAMP GPG Data Integrity Manufacturing Records Appendix 2, this is related to Manufacturing Execution Systems (MES) and so in some cases (Equipment Control) is not relevant for BatchLine EBR.

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GMP aspects of Electronic Batch Recording - Part 2: Risk Assessment for Recorded Data

4/14/2020

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This article is the second part of a series based on applying the GAMP Good Practice Guide (GPG) Data Integrity - Manufacturing Records
Continuing our article on the GMP aspects of Electronic Batch Records we look into the need and value of Risk Assessments; this appendix to the main GPG looks at threats to data integrity with data stored in a typical EBR.
How to perform a Risk Assessment for EBR data? Our Questions & Answers...
(Based on the GAMP GPG Data Integrity Manufacturing Records Appendix 2).

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GMP aspects of Electronic Batch Recording - Part 1: helping to meet ALCOA+ requirements

3/10/2020

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This article is the first part of a series based on applying the ISPE GAMP GPG Data Integrity - Manufacturing RecordsElectronic Batch Record (EBR) systems collect information about the process operation as the manufacturing progresses. Regulations require Batch Record data to be managed under the ALCOA+ principles, download the content below for a summary on how EBR ensures these principles and the typical improvement over paper record controls.

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