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 18 September 2003
Data Validation Compliance To FDA 21 CFR
Part 11
The Data Validation feature in ACR TrendReader Standard software is used to inform the person(s) viewing the printed or electronic data logger's data file (TRW) whether the data has been modified.
The Data Validation feature in ACR TrendReader Standard software is used to inform the person(s) viewing the printed or electronic data logger's data file (TRW) that the data has or has not been modified in any way since the data was extracted from the data logger
This article was originally published on Manufacturingtalk on 17 Oct 2003 at 8.00am (UK)
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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 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 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 download the latest version of the software (v.
1.22) from the ACR website for free (www.acrsystems.com).
All ACR data loggers using TrendReader Standard Software can use Data Validation, (SmartReader series, SmartReader Plus series and OWL series.) 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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