Data logging software upgraded to include data validation to US FDA 21 CFR Part 11, adding the security needed in today's digital world
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 term used to describe the process for ensuring integrity of data is data validation.
The data validation feature in TrendReader is used to inform the person(s) viewing the printed or electronic ACR data file that the data has or has not been modified in any way since the data was extracted from the data logger.
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.
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.
