Flow Cytometry 21 CFR Part 11 Compliance


Digital information has become an integral part of science. As we move more and more into paperless working practices, it is clear that we require ways to ensure the quality, integrity, and trustworthiness of electronic records. This is where United States Food and Drug Administration (FDA) Title 21 Code of Federal Regulations (CFR) Part 11 comes into the equation.

What is 21 CFR Part 11?

ZE5 Qualified IQ/OQ

21 CFR Part 11 is part of the regulations specified by the United States Food and Drug Administration (FDA) that govern food and drugs within the United States. Title 21 is the portion of the federal code that deals with food and drugs and Part 11 regulates the use of electronic records. In Europe the equivalent to 21 CFR Part 11 is EU Annex 11, with the exception, that at this time, Annex 11 is not applied to the manufacturing of medical devices. 21 CFR Part 11 sets the standard for the use of computerized systems for capturing and handling data, regulates the use of electronic signatures and sets the criteria under which they can be regarded as equivalent to handwritten signatures.

What is the Main Purpose of 21 CFR Part 11 and Why is it Important?

It provides the framework for the administration of electronic records in order to protect their integrity, confidentiality, and authenticity. It also provides guidance for industry best practice and ensures the nonrepudiation of electronic signatures.

What is an Electronic Record?

The FDA defines an electronic record as: "any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system."

What is an Electronic Signature?

The FDA defines an electronic signature as: "a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature."

Who Needs Part 11 Compliance?

Broadly, it applies to any records in electronic form that are created, modified maintained, archived, retrieved, or transmitted by organizations operating under any records requirement set forth by the FDA. Primarily these organizations are those that are engaged in the development or manufacturing of drugs, therapies, or medical devices. It does not stipulate the use of software for record keeping, however, the prevalence of electronic data and records means that 21 CFR Part 11-compliant software is widely used.

The ZE5 Cell Analyzer

The ability of flow cytometry to provide detailed multiparameter data at the single cell or single particle level has made it an indispensable research technology. Recent innovations have significantly increased the throughput possible with flow cytometry, transforming it into an essential tool for screening and drug discovery. Previously, once drug discovery progressed into environments that required regulatory compliance, the choice of instruments became limited. Now, we are pleased to be able to offer cutting edge flow cytometry, which can be applied to the entire drug discovery process.

Why Consider the ZE5 Cell Analyzer in Regulated Environments

  1. User-Friendly Features

    Some instruments require extensive training or require careful attention in their day-to-day use or maintenance. Not only is the ZE5 Cell Analyzer simple to learn, it also has a host of features that ensure continued operation regardless of user experience. Its crash proof probe, sample dry detection, and live fluidics monitoring ensure that mistakes do not lead to problems and deliver superb reliability.

  2. Expanding Your Capabilities

    Increasing the number of parameters that you can measure simultaneously has several advantages. It allows you to get more information out of each sample and help improve productivity, and reduce time to results. At the same time, having access to more channels means that you are better able to select dyes that have little or no spectral overlap, thereby improving data quality. With up to 5 lasers and 30 parameters, the ZE5 Cell Analyzer can be used for complex assays and allows the design of larger panels with little or no spectral compensation required.

  3. Increasing Your Throughput

    If your current system is struggling to keep pace with demand, one temptation may be to double-up but, consider the bigger picture. By making the switch to a more capable and faster instrument, rather than provide an incremental increase in throughput, you can deliver a step change. If you need to significantly increase the volume of samples that you can handle, no other instrument has the combination of high speed plate handling (96-well plate <15 minutes, 384-well plate <60 minutes) and high event rate detection (up to 100,000 events per second).

  4. Automation Ready

    Not only will automation dramatically increase throughput, it can also enhance reproducibility by removing errors associated with manual handling. The ZE5 Cell Analyzer has an agnostic API meaning that it can be integrated into a wide range of robotic work cells, for more information see our screening application page.

  5. Future Proof

    Making alterations to existing SOPs can be time-consuming and expensive. Rather than settle for an instrument that is adequate for your current needs, ensure that you have one that will continue to deliver as your needs grow and change. With its integrated universal plate loader, the ZE5 Cell Analyzer will adapt to your workflow.

  6. IQ/OQ Services

    Installation Qualification (IQ) and Operational Qualification (OQ) Services for the ZE5 Cell Analyzer ensure that your system functions properly and aid in regulatory compliance.

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ZE5 Cell Analyzer Compliance Checklist

Achieving Compliance

IQ/OQ Qualified Shield

Laboratory instruments themselves cannot be said to be compliant since full compliance requires codes of practice to be adhered to institutionally. However, instrument software can be roughly divided into software that supports compliance and that which does not. Traditionally, only the former would likely be considered for compliant environments. One alternative is the use of a second piece of software installed on the same instrument that adds compliance by building a level of security around data collected by the instrument.

Built-In Vs. Bolt-On Compliance Software

Although it may seem that an integrated compliance solution provides simplicity, there are advantages to employing a bolt-on 3rd party solution:

  1. Manages data audit trails, revision history, and electronic signatures within a single solution, rather than individual, integrated solutions that are siloed.
  2. Adopts a single solution, while still providing the flexibility to choose which features are required for each device.
  3. Grants access to a knowledgeable team of software compliance consultants with years of experience working with top pharmaceutical and life science companies.
  4. Adapts to changing regulatory landscapes.
  5. Validates a single solution one time, instead of multiple individual solutions, with a quality computer system validation team.

Bringing the ZE5 Cell Analyzer to Regulated Environments

Because of these advantages Bio-Rad chose to partner with experts in 21 CFR Part 11 software, to bring you the power of the ZE5 Cell Analyzer into a regulated environment.

Xybion Digital Inc

We are pleased to be working with Xybion Digital Inc. who specialize in unified all-in-one cloud software solutions for life sciences, health systems, and regulated industries, providing software solutions to more than 160 global companies.

Xybion's Compliance Builder software provides out-of-the-box functionality with audit trail, electronic signatures revision history, controlled user access, and much more.

Completing the Workflow: Compliant Analysis

FCS Express 7 Logo

Bio-Rad's long-standing partnership with De Novo Software provides a link to the final step in analysis to ensure that your entire workflow can support 21 CFR Part 11 compliance with FCS Express. FCS Express offers add-ons for security and logging features to help customers meet their bespoke needs for compliance through final analysis and reporting. FCS Express Clinical Edition can also be considered to help.

Supporting Features Available from De Novo Software

  • ✓ Network license configuration
  • ✓ Security and e-signatures
  • ✓ Logging and audit trails
  • ✓ LDAP/single sign on
  • ✓ LIS Integration
  • ✓ Advanced publishing for tech only flow
  • ✓ FCS Express IQOQ Validation
  • ✓ Multicycle for cell cycle analysis
  • ✓ Access limitations and authority checks
  • ✓ Record protection
  • ✓ Clinical edition

Download De Novo Software's 21 CFR Part 11 Compliance Matrix to see how FCS Express facilitates your compliance with each component of Part 11.

Speak to us about using the ZE5 Cell Analyzer with 21 CFR Part 11 support