CA Recorder/VR2 is
successfully used in the GLP environment. We are a
recognized leader
of GLP-compliant data acquisition, analysis, and
management systems.
- Validated by major
pharmaceutical companies and contract research
organizations
- Meets 21 CFR,
Part 11 user requirements throughout the system
- Proven quality
management system with Software
Development Life Cycle
- Complete
IQ documentation of your system from assembly to
post-installation
- Meets data analysis requirements for
ICHS7A guidelines
for cardiovascular, respiratory, neurological, and GLP
studies
- Onsite
training and validation support with complete SOPs and
certificates
- Validation
Help Book with list of SOPs for your in-house
validation
- Yearly
re-validation services
- Optional customized network security configuration can
be provided during on-site
installation
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GLP Validation
and Service
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Factory test and burn In
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In-house installation and testing of complete system
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All
development under proven and audited Software
Development Life Cycle
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Continuance validation support and methods available
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Maintenance contract available
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Knowledgeable technical support department
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System Security-
21 CFR Part
11
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CA
Recorder features a password system that is compliant
with the directives of 21 CFR Part 11. The system
administrator controls system access by assigning
temporary passwords with the CARADMIN security program.
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Audit
Trails-Electronic Signatures
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The
system automatically tracks all system access and every
significant action that an operator takes during the set
up and performance of an experiment. These actions are
logged by time and date of occurrence into a secure
audit file. Critical files are time stamped with the
operator’s electronic signature. These files are secure,
in that they are binary read-only files that cannot be
altered or modified by ordinary means.
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Documentation
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Standard operating procedures, installation
qualification test results, and release results are
available to users during validation. Also available
upon request are validation methods and guidelines for
use during on-site validation.
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ICH
Guidelines and
GLP Regulations
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-
Documentation
of your system from assembly to post-installation (IQ
documentation)
-
Validation help book with list of SOPs for your
in-house validation
Rule 11 user requirements throughout the system
- Meets
data analysis and requirements for
ICHS7A guidelines for
cardiovascular, respiratory,
neurological, follow up, and GLP studies
Proven
quality management system with proven Software
Development Life Cycle
|
