The FDA is changing the
way it oversees drug quality.
FDA commissioner Lester
Crawford states "We expect
to achieve greater research
efficiencies, easier data
management and lower costs".
See article in Next Generation
Pharmaceutical, p.135.
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Computer System Validation, Regulatory Compliance
and Lab Equipment
Qualification..
The consultants at Ridge Pointe Consulting are leaders in the
pharmaceutical industry regarding Computer Systems Validation.
With over
10 years of regulatory and validation experience, we provide high quality
services that meet the stringent FDA regulations and exceed your
expectations. Our validation methodologies ensure that your computerized
system is compliant, reliable, accurate, robust, and effective in meeting
your business and regulatory needs.
risk-based approach
streamlining without compromise
computer system validation
21 CFR Part 11
full system development
life cycle documentation
regulatory compliance consulting
compliance audits
strong project management
extensive industry experience with major
players
compliance training
> What's New?
Learn more about FDA's
5 major initiatives, including
Efficient Risk Management.
Also get more information
on FDA's Vision 2006.
