Product category:
Data acquisition Software and Communications
News Release from: ACR Systems | Subject: TrendReader
Edited by the Engineeringtalk Editorial
Team on 25 June 2003
Acquisition software gains data
validation
ACR Systems has upgraded its industry leading TrendReader software to include data validation, adding the security needed in today's digital world.
ACR Systems has upgraded its industry leading TrendReader software to include data validation, adding the security needed in today's digital world The Food and Drug Administration (FDA) allows the use of electronic records with electronic signatures
This article was originally published on Engineeringtalk on 24 Mar 2003 at 8.00am (UK)
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The FDA regulation, 21 CFR Part 11, outlines the requirements of the "system" used to gather and maintain electronic records and signatures.
The key to the regulation is data must be secure, also known as validatable.
The term used to describe the process for ensuring integrity of data is "data validation".
The data validation feature in TrendReader Standard is used to inform the person(s) viewing the printed or electronic ACR datafile (TRW) that the data have or have not been modified in any way since the data were extracted from the data logger.
Also files are assigned rights, read-only (you can only view, not modify, the processed data file) or CRC validation only (the file can be modified but will fail validation).
If a file is modified, even with the correct name and password, the file will fail validation.
This is to ensure that the data that was in the logger is the same data that you are viewing.
As the logger is tamper-proof (no buttons or switches) the entire system is protected from data manipulation.
"Data validation in ACR software brings ACR into the fore front of portable data logging with the cost and importance of pharmaceuticals, it is important that throughout the supply chain there is accountability; 21 CFR Part 11 is all about accountability and quality." The data validation feature is standard in TrendReader.
Current users of TrendReader can download the latest version of the software (v.1.22) from the ACR website for free.
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