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Regulations Overview Page

Pharmaceutical & Medical

21 CFR Part 11 Regulation

Ensuring vision system compliance

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At a minimum, a vision system should, in addition to performing all of its required functions, be able to do the following to be 21 CFR Part 11 compliant:

  • Limit system access to authorized individuals
  • On request, efficiently locate the appropriate records and provide copies suitable for review
  • Use audit trails that record the date and time of every operator action and entry that creates, changes, or deletes an electronic record
  • Confirm the identity of any individual who electronically signs a record
  • Ensure that no change obscures data previously recorded
  • Demonstrate that the results it generates are legitimate by validating against test data with known results

It is worth taking a closer look at a few of these requirements.

Limit system access

A compliant vision system must have a secure authentication mechanism to prevent unauthorized access. The best solution is a link to the manufacturer’s active directory account to verify users and issue the proper certificates. Any user or login changes must be logged and appear in the audit trail.

Use audit trails

In a compliant vision system, changes to a setting, for example, in a parameter on an image-based scanner, will create a timestamped record, a record which cannot be changed or erased, and can be examined by an auditor at a later time.

Validation

Users of a compliant vision system must demonstrate correct software installation through Installation Qualification (IQ), proper software operation through Operational Qualification (OQ), and the correct operation of the system in the production environment through Performance Qualification (PQ).

Cognex supports 21 CFR Part 11 compliance

While end-users are responsible for final validation to ensure full compliance, Cognex, along with our global network of integration partners, provides all documentation necessary to support IQ and OQ, and the software features necessary to complete PQ. All Cognex vision systems provide the security and access controls necessary to ensure compliance during operations.

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