Product category:
Telemetry, data acquisition + loggers
News Release from: ACR Systems | Subject: ACR TrendReader
Edited by the Processingtalk Editorial
Team on 16 September 2003
Data validation compliance to FDA 21 CFR
part 11
The Data Validation feature in ACR TrendReader Standard software shows whether the data has or has not been modified in any way since the data was extracted from the data logger
The Data Validation feature in ACR TrendReader Standard software is used to inform the person viewing the printed or electronic data logger's data file 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)
This article was originally published on Processingtalk on 21 Mar 2003 at 8.00am (UK)
Related stories
The smallest practical data logger available?
Is this single channel temperature logger the smallest practical data logger available? The ACR SmartButton measures and records up to 2048 time stamped temperature recordings between -10C to +85C
Temperature and relative humidity data logger
A new data logger that offers a cost-effective solution for recording temperature and relative humidity has been introduced by ACR Systems of Canada
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 (v1.22) from the ACR website free.
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.
• ACR Systems: contact details and other news
• Email this article to a colleague
• Register for the free Processingtalk email newsletter
• Processingtalk Home Page
Search the Pro-Talk network of sites
