Matrix 21 Cfr Part 11 Module Overview - revvity CELLOMETER ASCEND User Manual

Setting Up Auto Exports − The Matrix auto export feature allows you to select the Images (e.g., Raw Images and
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Colorized Images), Data (e.g., Well Level CSV, Object Level CSV and Object Level ACS) and Archive (e.g., Data Set)
output file types to be exported for an assay after completion of scan analysis. In addition, ACS templates can
be imported into the Matrix software and assigned to an assay. On export, data will auto populate into the
specified ACS template and can launch FCS Express if installed on your system and if the Auto Open option is
also selected.
• Customizing Reports − The Matrix custom reporting feature allows you to assign and/or modify report
templates to be used by assays when generating scan results. You can change the report template used for
displaying Well View tab data and manage the Reports List associated with an assay. You can also enable up to
five additional tabs or specify output file types (e.g., CSV, Excel, PDF and Word) to be automatically exported,
opened or printed after completion of scan analysis.
Managing Assays, Cell Types, ACS Templates and Report Templates − The Manage tab > Assays, Cell Types,
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ACS Templates and Report Templates options display lists of these entities currently loaded in your instrument
system. From these screens you can import/export, rename, delete or show/hide an entity in its applicable list.
For most entities you can also view, create or use locked entities as templates to create new ones.
Matrix Screen Elements on page 19 and Chapter 8. Matrix Counting and Analysis Workflow on page 31 are the only
sections in this manual that reference using the Matrix software. See the Cellometer Matrix Software User Manual
for a full description of Matrix software functionality.

MATRIX 21 CFR PART 11 MODULE OVERVIEW

The Matrix software offers a 21 CFR Part 11 module that is compliant with the Code of Federal Regulations (CFR)
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Title 21 Part 11 Electronic Records: Electronic Signatures published by the U. S. Food and Drug Administration
(FDA). In summary, this module ensures that an organization's use of electronic records and digital signatures to
replace traditional paper-based documentation complies with current FDA regulations.
Key elements in Matrix 21 CFR Part 11 module functionality are described below:
Electronic Signatures are captured during the counting and analysis workflow using e-Sign/e-Unsign buttons
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and include the name of an authorized user, date/time when the signature was executed, reason for the
action being performed and meaning of the signature (i.e., for the Review, Approval or Rejection of an action).
If a user's assigned role does not have permissions to approve count results, a supervisor can log in to e-Sign
the record on behalf of the user.
• Electronic Records are created by linking electronic signatures to user actions ensuring that records have not
been copied or falsified in any manner.
• An Audit Trail provides assurance regarding the integrity of an electronic record and continually monitors all
users performing actions, the type of actions performed, and the date/time associated with user actions.
This module may be enabled for your instrument at time of purchase or implemented as an upgrade in the field by
Support. See the Cellometer Matrix Software User Manual for a full description of Matrix 21 CFR Part 11 module
functionality.
8004708 Cellometer™ Ascend User Manual Rev A
Chapter 1. Introduction
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