The 2100 expert software is the first step to develop the 2100
bioanalyzer for the use in regulated environments, such as pharmaceutical
QA/QC labs or manufacturing. The second step will be the addition
of a security pack, including all features required for full 21
CFR part 11 compliance, such as electronic signatures, audit trails
and user authentication. The 2100 bioanalyzer has proven to be
a popular alternative to traditional methods such as gel electrophoresis.
Speed, automation, reliability and digital data delivered by the
Agilent 2100 bioanalyzer system are the key advantages for quality
control. The needs of quality control labs are addressed by delivering
IQ&OQ/PV support services and 'Declarations of Conformity'
for all components, prerequisites for work in regulated environments.
Design Qualification (DQ)
DQ defines that functional and operational specification of the
2100 bioanalyzer system and ensures that it has all the necessary
functions and performance criteria.Documents provided for the
2100 bioanalyzer system include:
- Declaration of System Validation
- Declaration of Conformity for Instrument to Manufacturing
Specification
- Declaration of Conformity for Instrument according to ISO/IEC
Guide 22 and CEN/CENELEC EN 45014
- Declaration of Conformity for chips and reagents
Installation Qualification (IQ)
Installation Qualification (IQ) ensures that the Agilent 2100
bioanalyzer instrument and the 2100 expert software are installed
correctly upon delivery.
Operational Qualification (OQ)
OQ is the process of demonstrating that an instrument will function
according to its operational specifications in the selected environment.
21 CFR part 11 Compliance
Full compliance requires that the software fulfils all rules defined
under 21 CFR Part 11. This specifies the requirements of electronic
recording, such as data security, data integrity and audit tractability.
The 2100 expert software alone does not comply with these regulations.
However, this will be achieved with the release of the 2100 expert
security pack available in a second phase. The installation of
the 2100 expert software is prerequisite for the 2100 expert security
pack.
Agilent
2100 bioanalyzer