21-CFR Part 11 Data Loggers

We offer data loggers and monitoring systems from several different manufacturers that offer firmware/software to allow them to operate as part of an FDA 21 CFR Part 11 compliant system. They can be used in applications including pharmaceutical manufacturing and distribution, hospitals and life sciences, and food and beverage production.

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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.

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