Product category:
Measurement and Quality Software and SPC
News Release from: ACR Systems | Subject: Trendeader software upgraded
Edited by the Manufacturingtalk Editorial
Team on 27 June 2003
Data Validation Compliance to 21 CFR
Part 11
ACR Systems has upgraded its industry leading Trendeader software to include Data Validation.
ACR Systems has upgraded its industry leading Trendeader software to include Data Validation By adding data validation to the already popular TrendReader software it adds the security needed in todays digital world
This article was originally published on Manufacturingtalk on 25 Jun 2003 at 8.00am (UK)
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The Food and Drug Administration (FDA) allows the use of electronic records with electronic signatures.
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 data file (.TRW) that the data has or has not been modified in any way since the data was 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.
Since 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 (www.acrsystems.com).
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