Data Sheet

Agilent 2100 Bioanalyzer SystemCompliance Solution

Feel Safe in Regulated Environments
The Agilent 2100 Bioanalyzer compliance solution provides an integrated and reliable
tool for quality control of nucleic acids and proteins. It supports the validation processfrom start to finish, enabling users to run the Agilent 2100 Bioanalyzer system inregulated lab environments. The Agilent 2100 Bioanalyzer compliance solution
comprises the 2100 Bioanalyzer instrument, software, services, as well as applicationspecific consumables. With Installation Qualification (IQ) and Operational Qualification(OQ) services, and the 2100 Security Pack, the Agilent 2100 Bioanalyzer system caneasily be made compliant for 21 CFR Part 11 including quality control and analysis ofantibodies, protein pharmaceuticals and other biomolecules.

Key Features
2100 Bioanalyzer system – anintegrated compliance solution– 2100 Bioanalyzer instrument
and 2100 Expert software– Electrophoresis cartridge– RNA, DNA and Protein kits
– Design qualification
documentation– Compliance services(2100 Bioanalyzer IQ or
OQ service)– 2100 Security Pack license– Reproducible results: System with prepackaged kits, standardized protocols and 		optimized assays– High quality data: On-chip automated electrophoresis results in reliable digital dataand provides objective information regarding concentration, size and integrity– Compliance services: Software and hardware IQ and OQ can be purchased at anytime. A certified engineer will test and verify the functionality of the hardware andsoftware, thereby qualifying the system– Enabling 21 CFR Part 11 compliance: With the Security Pack add-on, all requirements
for electronic records and electronic signatures are addressed, including data security,
integrity and traceability– Design qualification: Functional and operational specifications are defined by thedeclaration of conformity for the 2100 Bioanalyzer instrument and kits and thedeclaration of system validation for the Agilent 2100 Expert Security Pack software– Accepted standard: Established for quality control of RNA, DNA and protein samples
with citations in over 50,000 scientific papers

GLP/GMP ComplianceGood Laboratory Practices (GLP) and Good Manufacturing
Practices (GMP) are guidelines to ensure minimal requirements are met for quality management or research facilities

and/or manufacture of food and pharmaceutical products.
These practices ensure uniformity, consistency, reliability,reproducibility, quality, and integrity of laboratory tests.

DesignInstallStart UpOperate

DesignQualification

Installation
Qualification

Operational
Qualification

Performance
Qualification

DQ

IQ

OQ

PQ

Figure 1. Validation process.

The Agilent 2100 Bioanalyzer compliance solution supports
the validation process from start to finish, regardless ofwhether you are analyzing nucleic acids, or proteins.

Design Qualification (DQ)
DQ defines the functional and operational specifications of
the 2100 Bioanalyzer system and ensures that it has passed
all performance criteria.

components are unpacked to the point the system is readyfor operation – documenting the completeness of shipping,
the operating environment, and the components of thesystem. The correct installation of the software is checkedin the verification context of the 2100 Expert software.

Operational Qualification (OQ)

– Declarations of Conformity for all assay kits

OQ is performed to verify and document the 2100 Bioanalyzer
system’s ability to meet specified performance criteria
ensuring basic accuracy of the system after it is installedin the selected environment. OQ should be performed after
hardware or software updates, repair, or relocation and atregular intervals during routine use. Agilent recommends
performing preventive maintenance prior to an OQ.

Installation Qualification (IQ)

Performance Qualification (PQ)

Documents provided:– Declaration of System Validation for the 2100 Expertsoftware– Declaration of Conformity for 2100 Bioanalyzer instrument

IQ ensures that the Agilent 2100 Bioanalyzer instrument
and the 2100 Expert software are installed correctly and allelectrical connections are correct – from the moment thePQ confirms that the system functions according to theneeds of the application. The customer is responsible
to develop Standard Operating Procedures (SOPs) forprocessing and analyses of their samples.

Table 1. Compliance services from Agilent.
Installation Qualification (IQ)

Operational Qualification (OQ)

Hardware IQ

Software IQ

Hardware OQ

Software OQ

Confirm correct installation of the2100 Bioanalyzer instrument.

Confirm correct installation of the 2100
Expert software.

Perform instrument validation tests.

Data calculation engine and softwarealgorithm test.

Documentation of instrument details
and system check.

Documentation of software details
and integrity of installed software
components.

Audit-ready documentation
confirms 2100 Bioanalyzer
system performs according tooperational specifications.

Audit-ready documentation confirms
2100 Expert software performs
according to operational specifications.

Certification to provide audit-readydocumentation.

Certification to provide audit-readydocumentation.

2Enabling 21 CFR Part 11 ComplianceFull compliance requires the software to fulfill all guidelines
in Title 21 CFR Part 11 defined by the US Food and Drug
Administration (FDA) specifying the requirements forelectronic recording. This code dictates particular FDAregulated industries to implement controls for electronic
documentation and data integrity – such as audit trails andelectronic signatures – of software and systems involvedin processing electronic data.

Table 2. 2100 Security Pack user roles.
Operator

Permission

Standard Operator

Run methods

Advanced Operator

Develop and modify methods

2100 Administrator

Setup of users

Backup Operator

Archiving/de-archiving files

Validation Operator

Validation of system

2100 Unlock Operator

Unlock system after timing out

The Security Pack module (G2949CA) within the 2100 Expert
software allows for operation in a fully secure environment
and makes the 2100 Expert software fully compatible with21 CFR Part 11.

– Workflow management: Customer developed methods
detail the instrument, assay type, the users and the numberof peer review cycles the data must go through before final
approval or rejection– Data integrity: Data can only be modified or deleted byauthorized users, all data files contain the raw data andthe complete history– Version control: Even for a finalized method, the different
versions of the workflow can be opened for review.

– Access control: No one can acquire or access data
without a proper user account and identification. Users areclearly identifiable with distinct user names and passwords.
Only the 2100 administrator has access to the user androles administration– Electronic signature: All activities such as creating or
modifying data have to be confirmed by an electronicsignature– Audit trail: All actions performed within the secured
environment require an electronic signature and are tracked
and documented with a clear, traceable audit trail and in
logbooks

Figure 2. Electronic signature.

Figure 3. All actions are listed in the audit trail of the software.
3

www.agilent.com/genomics/bioanalyzer
For Research Use Only. Not for use in diagnostic procedures.
This information is subject to change without notice.
© Agilent Technologies, Inc. 2019
Printed in the USA, February 1, 20195991-7893EN