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Countess™ 3 21 CFR Part 11 Software Module
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Experience nuclei counting with fluorescent-mode counting algorithms, simplified workflows, built-in dilution calculators and reports using the latest version of Countess software with optional 21 CFR Part 11 compliance. Download now!
Countess™ 3 21 CFR Part 11 Software Module
Invitrogen™

Countess™ 3 21 CFR Part 11 Software Module

The Countess 3 21 CFR Part 11 Software Module is for use with the Countess 3 and Countess 3 FLRead more
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Catalog NumberQuantity
A51025Promo Image1 license
Catalog number A51025
Price (USD)
3,890.00
Each
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Quantity:
1 license
Price (USD)
3,890.00
Each
Add to cart
Ask our AI about this Product

The Countess 3 21 CFR Part 11 Software Module is for use with the Countess 3 and Countess 3 FL automated cell counters and supports compliance with 21 CFR Part 11 FDA guidelines for security, auditing, and electronic (SAE) signatures using an SAE administration console.

21 CFR Part 11 compliance is composed of both procedural and technical requirements. Procedural requirements are the standard operating procedures instituted by the end user, and technical requirements are the functional characteristics of the compliance management software used. Both procedural and technical requirements must be met to achieve 21 CFR Part 11 compliance for traceability of electronic records.

To implement the Countess 3 21 CFR Part 11 Software Module for 21 CFR Part 11 support on the Countess 3 and Countess 3 FL automated cell counters, the following components are required to be installed, activated, and communicating:

  • SAE Administrator Console—installed on a local server and allows configuration of the SAE settings for Countess 3 automated cell counters with the Countess 3 application profile
  • Countess 3 21 CFR part 11 license key—used to activate the SAE settings for the Countess 3 automated cell counter
  • Countess 3 instrument, with SAE mode enabled—connected to the SAE Administrator Console

Features of the Countess 3 21 CFR Part 11 Software Module include:

Security

  • Authentication of user login information
  • Ability to set password guidelines and expiry dates
  • Lockout access and re-authentication requirements after a period of inactivity
  • System lockout upon unauthorized attempts to access software
  • Ability of administrator to define user roles and permissions
  • Verification of each user's permissions to perform predefined activities
  • Identification of data tampering

Auditing

  • Generation of audit trail log
  • Tracking of changes and committed actions to user roles, account management, and system settings
  • Ability of administrator to determine functions required to input reason for commit
  • Audit trail record presented in readable and filterable formats

Electronic signature

  • Administrator determination of e-signature requirements
  • Ability to review records and sign electronically

Along with the 21 CFR Part 11 software, our service and support organization offers IQ/OQ qualification services for your instrument and support training.

For Research Use Only. Not for use in diagnostic procedures.
Specifications
For Use With (Equipment)Countess 3 & Countess 3 FL
Includes21 CFR, part 11 activation key
Quantity1 license
Unit SizeEach
Countess App Note

Explore protocols, tips & optimal conditions for
single-cell analysis on Countess Automated Cell Counters

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Frequently asked questions (FAQs)

Where can I find the service retirement letter for the Countess II and II FL Automated Cell Counters?

You can find the service retirement letter for Countess II and II FL Automated Cell Counters below:

Important end-of-life communication for Countess II and II FL products

Find additional tips, troubleshooting help, and resources within our Cell Analysis Support Center.

Where can I find FAQs for Countess II and II FL Automated Cell Counters?

Countess II and II FL Automated Cell Counter FAQs can be found in our Product FAQ Database.

Find additional tips, troubleshooting help, and resources within our Cell Analysis Support Center.

Where can I find a troubleshooting information for Countess 3 and 3 FL Automated Cell Counters?

Troubleshooting information for Countess 3 and 3FL can be found on the Cell Counting Support Center.

Find additional tips, troubleshooting help, and resources within our Cell Analysis Support Center.

What is the shelf life for Countess Cell Counting Chamber Slides, disposable?

Our guarantee period for disposable Countess Cell Counting Chamber Slides is 5 years.

Find additional tips, troubleshooting help, and resources within our Cell Analysis Support Center.

How can I find information on the regulatory and compliance standards for my Countess 3/3FL Automated Cell Counter?

For information on the regulatory and compliance standards for my Countess 3/3FL Automated Cell Counter, including 21 CFR Part 11, IQ/OQ, and warranty packages, please see refer to Countess Automated Cell Counter Services on our website.

Find additional tips, troubleshooting help, and resources within our Cell Counting Support Center.

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