Product category:
Measurement and Quality Software and SPC
News Release from: ACR Systems | Subject: ACR TrendReader Standard software
Edited by the Manufacturingtalk Editorial
Team on 17 October 2003
Data Validation Compliance to CFR 21
part ii
The Data Validation feature in ACR TrendReader Standard software, available from Just Data Loggers is used to inform the viewer that the data has or has not been modified since the data was extracted.
The Data Validation feature in ACR TrendReader Standard software, available from jdl (Just Data Loggers, the official UK sole distributor for ACR), is used to inform the viewer that the printed or electronic data logger's data file (TRW), an ACR TrendReader data file, that the data has or has not been modified since the data was extracted from the data logger Data files are also assigned rights, Read-Only (the viewer can only view, not modify the processed data file) or CRC Validation Only (the file can be modified but will fail validation)
This article was originally published on Manufacturingtalk on 18 Sep 2003 at 8.00am (UK)
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If a file is modified, even with the correct name and password, the file will fail validation.
This is to ensure that the data in the logger is the same data that is being viewed.
Since the data logger itself is tamper-proof (no buttons or switches), the entire system is protected from data manipulation.
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 that 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 is applicable to TrendReader Standard software.
Current users of TrendReader can freely download the latest version of the software (v.
1.22) from the ACR website free (www.acrsystems.com).
All ACR data loggers using TrendReader Standard Software (SmartReader series, SmartReader Plus series and OWL series.) can use Data Validation.
Validation is used in many industries such as, pharmaceuticals, food and drinks production, food preparation and transportation, hospitals, and many other critical applications.
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