Data validation feature in software ensures that the data being used is the same as the data that was logged, and is compliant with 21 CFR part 11
The Data Validation feature in ACR TrendReader Standard software is used to inform anybody viewing the printed or electronic data logger's data file (TRW) that the data has or has not been modified in any way since being 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 is being viewed.
Since the data logger itself is tamper-proof (no buttons or switches) the entire system is protected from data manipulation.
The US 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 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 All ACR data loggers using TrendReader Standard Software can use data validation, (SmartReader series, SmartReader Plus series and Owl series).
