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Check out
our new product |
Risk-Based
Validation
Manager
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cGMP
Systems provides value-added services that are
pragmatic and
cost-effective.
Our unique combination of pharmaceutical
expertise and software development experience
makes us the first choice for pharmaceutical
companies around the world.
We offer specialized services in the
following industry segments:
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| (A)
Risk Assessment & Compliance Services |
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cGMP Systems compliance consultants are
domain experts (most are faculty members
of the PDA-TRI and other industry
organizations).
Our services
include:
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Risk Assessment & Risk-Based
Validation:
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Customization of library
of assessment questions
& validation actions.
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Creation of “master”
assessments for
system-types and
processes.
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Inventorying of systems
and processes.
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Facilitation of
assessment working
sessions and capturing
of results.
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Creation of customized
reports
- Compliance
Audits
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Validation: Facilities, Equipment, Cleaning, IS/IT, Process, 21CFR Part 11
- GMP
Systems Development
- Training
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| (B)
Software Development Services |
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cGMP Systems takes pride in our software
development methodology.
We utilize a modified waterfall
approach for our development projects
and have been successfully audited by
our pharmaceutical clients.
We use well-documented SOPs and
share our procedures with our clients.
Our experts develop products
using standard tool sets including:
- JAVA2
& J2E
- VB
- Oracle
- SQL
Server
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| (C)
Project Management |
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Recognizing cGMP Systems industry
expertise, many clients utilize our
teams to manage their projects.
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