Pharmaceuticals Solutions Group
Introduction
The Pharmaceutical Solutions Group is
dedicated to providing control systems and validation solutions for
FDA regulated industries, specializing in compliance with 21CFR
parts 11, 210, and 211. Balancing the latest technology with rapid
development and deployment, the Pharmaceutical Solutions Group
consistently provides a wide range of systems that drive, monitor,
adjust, and support operations within your business environment.
About the Industry
Our engineering, programming, and validation
staff has extensive experience within regulated industries. What
that means to you is we have the experience and knowledge to design,
implement and program solutions for you that are validible. Projects managed by our Pharmaceutical Solutions Group integrate
validation throughout the entire project, reducing costs and time
for post-design remediation efforts. At Frakes Engineering we
recognize that project management can be the difference between just
meeting customer expectations and exceeding them. All of the
projects managed by the Pharmaceutical Solutions Group are under the
direction of a Project Management Professional certified by PMI®,
the world’s leading association for the project management
profession. Computer System Validation (CSV) involves providing
documented proof that a computerized system will repeatedly and
reliably do what it is supposed to do. Our work is focused on
helping clients achieve compliance with FDA expectations.
Some of Our Qualifications
Frakes Engineering is a certified
member of the Control System Integrators Association (CSIA), the
largest organization of independent control system integrators in
North America. We have earned "Certified Member" distinction,
meeting stringent performance standards as measured in an intensive
audit process conducted by an independent third-party consulting
firm. The audit focuses on best practices in general management,
financial management, project management, quality management,
technical management, human resources, and business development. Frakes Engineering is proud of our status as a Microsoft Certified
Partner. Our focus on computer systems has also led to membership in
the Authorized Reseller programs of Hewlett-Packard and Compaq.
How We Can Help
From envisioning a new solution, through
planning, developing, and validating existing systems, Frakes
Engineering has the experience to address your needs at any phase of
a project. Find out today how Frakes can help you get the most out
of your resources and drive your manufacturing in the direction you
want it to go. |
Application Profiles
Additional Resources
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