Agilent The Agilent 2100 Bioanalyzer System - A compliant Tool in the Life Sciences IQ OQ/PV 21CFR part 11 Manual(1)

The Agilent 2100 Bioanalyzer is an integrated, inexpensive, compliant solution for the analysis of nucleic acids, proteins, or cells. It is equipped with IQ, OQ/PV, and 21CFR part 11 compliance, making it suitable for quality control and analysis of antibodies, protein pharmaceuticals, and other biomolecules such as RNA and DNA.


Agilent The Agilent 2100 Bioanalyzer System - A compliant Tool in the Life Sciences IQ OQ/PV 21CFR part 11 Manual(1) - cover page
Brand
Agilent
Document type
Product Leaflet
Language
English
Pages
6
File format
PDF
File size
179 KB
Published
11 June, 2012
Updated
28 September, 2023
MD5 checksum
06A8CC4AFB9FF7D18427C820EC89125B

About this manual

The document provides a technical overview of the Agilent 2100 Bioanalyzer, an integrated solution using lab-on-a-chip technology to analyze nucleic acids, proteins, or cells. It highlights how the new Agilent 2100 expert software (G2946CA) enables operation in regulated lab environments by supporting IQ/OQ/PV and 21CFR part 11 compliance.

The text details the hardware and software requirements for the system, including PC specifications and available license modules. It also describes the specific Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Verification (PV) services offered by Agilent to ensure the instrument meets quality standards in pharmaceutical QA/QC labs.

What's inside

  • Technical Overview
  • Agilent 2100 expert software
  • Hardware and Software Requirements
  • Compliance Services
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Verification (PV)

Specifications

Analysis Timeless than 30 minutes
Sample Capacityup to 12 samples
CPU RequirementPentium IV
RAM Requirement512 Mbyte
Hard Disk Requirement60 Gbyte

Frequently asked questions

What is the purpose of the Agilent 2100 expert software?

It enables users to run the Agilent 2100 Bioanalyzer in regulated lab environments with support for IQ/OQ/PV and 21CFR part 11 compliance.

What does the RIN score measure?

It objectively assesses the quality of an RNA sample by determining its integrity.

What are the three available software modules?

The three modules are electrophoresis, cell fluorescence, and security pack.

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