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The NetFabric Validation Services Practice is focused towards helping you
manage the IT validation/Quality Assurance activities that support your
IT/business functions in a regulated or non-regulated environment. These
are the broad areas of service that your organization will benefit from:
IT Validation
- Validation of computer &
computerized systems
- 21 CFR Part 11 Support
- Training
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Quality Assurance Support
- Quality/Compliance Auditing
- Compliance Appraisal
- Quality Project/Process Management
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Services
The practice has in-house resources that specialize in validation of
computer and computerized systems, general PLC validation,
system/software upgrade qualification, Part 11 Assessment, Part 11 Gap
analysis, and Remediation of systems for Part 11 Compliance. You will
benefit from our services specifically in the areas of:
- Validation/Quality Planning,
Execution, and Reporting
- 21 CFR Part 11 Assessments, Gap
Analysis, and Remediation
- Appraisal of Systems for Regulatory Compliance
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- Quality Project/Process Management
- Quality/Compliance Auditing
- On-site Training on Computer System Validation and Part 11, and
related governance processes
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Industry Experience
Whatever the size of your firm - large, medium, or small - you can benefit
from our services.NetFabric has had the privilege of accruing a wealth of
business, Information Technology, and validation because of the
opportunities provided to us by our customers. Our industry experience in
the area of validation is made up of:
- Business expertise
Extensive knowledge base derived from many years of successful delivery
to a diverse clientele within the life sciences industry; working
knowledge of GCP, GMP, GLP, and GAMP.
- Systems Expertise
These are the systems that our clients have engaged us for, but not
limited to: clinical data acquisition and management systems,
statistical reporting systems, manufacturing and laboratory systems,
health and safety management systems, medical dictionaries, instrument
interfaces, networking systems, database systems, and operating
systems.
- History of reliability
Credentialed customer references on the services that our customers have
engaged us in, since our inception in 1996. Our clients have benefited from
our capabilities and assistance in establishing effective processes to meet
their validation/QA goals.
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