21-CFR Part 11 Data Loggers

There are 3 important groups of features for compliance with the CFR requirements:

1. User management with secure user login, multiple levels of access and automatic inactivity log out.
2. Audit trail to provide a record of any changes to the configuration and settings of the system.
3. Data storage in an unalterable forma to prevent after the fact modifications.

In addition to this there are several other features that provide additional functionality that most users find useful:

1. Corrective action notes in the event of an alarm to enter information as to both the cause of the problem and what was done to resolve the issue.
2. Built-in report generation  for login activity, configuration changes, corrective action and monthly data summaries for record-keeping.

Read Less…