CFR Part 11 Compliance

The Problem

FDA’s Electronic Records and Electronic Signatures Rule (“Part 11”) defines the requirements for submitting documentation to FDA in electronic form as well as criteria for use of electronic signatures.  These regulations – which affect the creation, maintenance, transmission, storage, modification, and submission of electronic records -- have added new challenges to the regulated life science industries. To verify conclusions you make from test data, FDA wants to be able to use the same tools to evaluate data that you did.  The FDA also requires that you can account for every detail as to how you arrived at your results. Key to such data evaluation and manipulation is a means to control the metadata – the data that software uses to render your data into meaningful reports.

The Solution

FCS Express with CFR Part 11 Compliance. Designed to maintain both the machine-readable metadata and human-readable reports, FCS has the following features to enhance your Part 11 compliance program: 

  • Security, Access Limitations, and Authority Checks allows you to control which functions people are allowed to perform on a user-based and layout-based level. Over 300 independent security permissions can be set for each security group, giving you tremendous flexibility in defining your own access limitations.
  • Record Protection prevents unauthorized manipulation of FCS Express metadata and reports.  Flow cytometry raw data can also be stored with metadata and reports, facilitating protection and traceability.
  • Audit Trails: FCS Express employs secure, computer-generated, time-stamped audit trails to track actions that create, modify, or delete FCS Express layout files and reports.
  • Electronic Signatures: When users are satisfied with their flow cytometry report, they can electronically sign it. Signing events are maintained in the audit trail.  Signed reports can be securely transferred in a variety of formats to your laboratory information management system.
  • Much, much more: sophisticated encryption, print logging, print tagging, password aging and many other features serve to help you ensure that your flow cytometry analysis is in full compliance with Part 11 regulations.

Our 21 CFR Part 11 Compliance Matrix highlights all of the Part 11 regulations and how FCS Express facilitates your compliance with them.

In today’s regulated environments, it is more important than ever to ensure that your experiments meet the highest standards of traceability, reproducibility and accuracy.  FCS Express – now with 21 CFR Part 11 Compliance Support – meets those needs.
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