Incucyte 21 CFR Part 11 Software Module | Sartorius

Incucyte® 21 CFR Part 11 Software Module 

Incucyte® 21 CFR Part 11 Software Module (Cat.No. BA-04876) offers comprehensive security and electronic record keeping functionality. It is available to purchase for all S-series instruments and requires 2023A software version or higher.


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Software Overview

The Incucyte® 21 CFR Part 11 Software Module enables 21 CFR Part 11 required functionality:

  • Electronic Record Keeping and Traceability
  • Security and User Management
  • Electronic Signatures and Standardized Comments

The Incucyte® 21 CFR Part 11 Software Module provides the ability to set the specific level of stringency required for your laboratory with user roles, experiment visibility and adherence to templates. All events and user actions are automatically captured in an audit log that can be filtered for customized reporting. 

   

Incucyte® 21 CFR Part 11 Software Module Features

Software Features

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Electronic Record Keeping and Traceability

  • Global event audit log
  • Electronic signatures
  • Customizable checkpoints

Security and User Management

  • Windows Authentication
  • Curate experiment access
  • User permissions

Standard Operating Procedure Control

  • Track any experiment changes against an SOP
  • Limit select user roles to only follow SOPs
  • Lock and approve finalized experiments

Ordering Information

Related Incucyte® Resources

Protocol

Introducing the New Incucyte® 21 CFR Part 11 Software Module

PDF | 232.4 KB
Incucyte - Empower Live-Cell Analysis Inside Your Incubator
Brochure

Live-Cell Analysis Systems Brochure

PDF | 10.1 MB

Incucyte® Reagents, Consumables and Software Brochure

PDF | 6.1 MB

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