Modernized 21 CFR Part 11 Ready Software for Improved Workflow

21 CFR Part 11 Cell Counting

Nexcelom delivers industry-leading cell counting systems with ready-to-use protocols that can generate highly accurate and precise cell counting results. Nexcelom continues to provide expertise using ISO Cell Counting Standards to modernize your fit-for-purpose cell counting methods to support:

  • Easily accessible systems with high intra-instrument precision
  • Turnkey workflow solutions with scalable 21 CFR part 11 options, allowing for less training time when moving between instruments
  • The ability to harmonize and streamline cell-based assays between groups with low and high-throughput needs
  • Recommendations for acceptance, maintenance, submission, and storage of electronic records and signatures

Scalable 21 CFR Part 11 Solutions

Virtual or In-lab Demo
Cellometer K2

Cellometer K2 Fluorescent Cell Counter makes viewing, analyzing, and reporting on complex and messy samples even more accessible.

  • As low as 10 µl of a cell sample is required
  • Generate counts, concentration, viability, and size in less than 60 seconds
Cellaca MX High-throughput cell counter

Cellaca MX High-throughput Cell Counter automatically counts up to 24 samples in minutes.

  • As little as 25 µl of a cell sample required
  • Multiple fluorescent filter options with autofocus function
  • Perform cell-based assays including viability, vitality, and apoptosis

Celigo Express Software with 21 CFR Part 11

Celigo Image Cytometer

Celigo Whole-Well Image Cytometer performs cell-based assays with adherent and suspension cells in only a few clicks using various types of vessels without disturbing the natural cell state.

  • Fully automated live-cell analysis and cell sample characterization
  • Simplify the data acquisition process by running a scan in minutes

Improve Workflow Quality and Security

Nexcelom offers consistent instrumentation with several advantageous features to further improve workflow quality and security including:

  • Audit trails, time stamping, user access control, and electronic signatures
  • File locking and change tracking
  • Creation of new customizable defined roles with multiple configurations available
  • A close-looped database system to aid with data integrity and security
  • Built-in assays with optimized settings for over 400 individual cell types
  • Customizable data and calculation reports with graphs, images, charts, and tables for ease of information sharing

Understanding Role Privileges

Roles are used in the Matrix 21 CFR Part 11 module to control the following areas of responsibility:

  • Data – Control, create, manage, export/import, and approve/reject data during the counting and analysis workflow
  • Settings – Access the Assays, Cell Types, and Report Templates options under the Manage tab to create, manage, and export/import these entities
  • Users, Roles, and Audits – 21 CFR Part 11 ready module allows users creation and management of the Matrix software Users, Roles, and Audits options under the Manage tab to monitor the audit trail automatically generated by the system
21 CFR Part 11 privileges