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21 CFR Part 11

21 CFR Part 11

Manage and Control Electronic Records for FDA Regulated Products

Do you produce an FDA regulated product? Do you use computerized systems to generate batch records? Do you submit data to the FDA in electronic formats? If so, you may have to comply with federal regulation 21CFR Part 11.

21 CFR Part 11 applies to electronic records and electronic signatures when an entity relies on the digital form of the data in lieu of the paper equivalent. There are a few categories of data that are considered within the scope of this code of regulation:

  • Records required by the FDA to be maintained under the predicate rule
  • Records submitted to the FDA under the predicate rules
  • Electronic signatures serving to be an equal substitution to handwritten signatures

The key to the inclusion of all the above categories into the control system is that the electronic form of record or signature is the form relied on in lieu of the paper equivalent.

Four Requirements for Freeze Drying Compliance to 21 CFR Part 11


Data Encryption and Storage

When the protocol is initiated a batch log is created where all measurements, alarms, and changes are recorded in an encrypted file. All batch records are stored and available for reference for later reporting.


Audit Trails

A batch report can be printed in PDF format that includes the operator name, protocol, data measurements over time, graphic data, alarms, and a log of any adjustments made to the cycle.


Electronic Signatures

The freeze drying protocol is entered step by step. Where a step requires an electronic signature, the change is logged. The protocol or recipe is stored and available for use.


User Password Levels

Each user is given a username and password with a user level that provides restricted access to sections of the system.

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