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

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).

Type of Data & Questions​	Answers considering the use of EBR
Automatically captured process data	​See Article Part 1 for details on capturing machine data
Where & for how long is the data stored	​If stored in EBR the data does not need to be stored in the equipment after transfer. Data-flows must be assessed for risks to data integrity between each step of the automated process (data creation, processing, transfer etc.), the controls put in-place to ensure GMP requirements must be validated including an appropriate storage system for the records to be retained.
What is the accuracy of measurement	This is related to the instrument in the equipment, ensured by effective calibration procedures, and ensuring then data flow from data creation in the instrument to final storage in the record maintain its consistency.
Are the data sample rates appropriate	​This is related to the instrument & the equipment process, focus should be on the frequency of data capture required for batch review decisions – not all data is required to be captured in the EBR
Where are the time stamps applied	Time stamps are added and ensured by the EBR as the system of record

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 Author
​Dr. Tony Margetts, Principal Consultant at Factorytalk
Dr. Tony is considered a global expert in the fields of GMP compliance and validation with +30 years working experience in the Pharmaceutical, Medical device, and regulated industries. Dr. Margetts has also been involved in producing several of the GAMP/ISPE good practice guides including leading roles in GAMP5, and recent document “The ISPE Good Practice Guide to Electronic Record & Data Integrity” which was published in 2017.

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