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revvity CELLOMETER ASCEND - Instrument and Software Validation; Cellometer Ascend IQ;OQ Validation; 21 CFR Part 11 OQ Validation

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Chapter 4. Unpacking and Site Preparation
8004708 CellometerAscend User Manual Rev A 17
INSTRUMENT AND SOFTWARE VALIDATION
Cellometer Ascend IQ/OQ Validation
Revvity, Inc. has designed an Installation Qualification/Operation Qualification (IQ/OQ) validation specifically for
the Cellometer Ascend. Our experienced Support team is available to assist your organization during set up of the
instrument and while performing the IQ/OQ validation. For more information, contact Support by visiting
https://www.revvity.com/contact-us or send an email to: CellC-support@revvity.com
21 CFR Part 11 OQ Validation
If you have enabled Matrix 21 CFR Part 11 module functionality for your system, a separate OQ validation has been
designed as a supplement to be run in conjunction with the Cellometer Ascend IQ/OQ Protocol.
Note: Integrating the Matrix 21 CFR Part 11 OQ Protocol Supplement into the Cellometer Ascend IQ/OQ Protocol
requires that you have purchased a Matrix 21 CFR Part 11 module license and the CMT-ASD-21MX-IQOQ Kit.
Our experienced Support team is available to assist your organization during set up of the instrument and while
performing the IQ/OQ validation. Contact Support by visiting https://www.revvity.com/contact-us or send an
email to: CellC-support@revvity.com

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