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AUDITING SERVICES:
Auditing services are available to meet the requirements of cGMP/QSR/ISO
auditing
programs, supplier audits, and preparation for successful outside-agency
audits.
In all final audit reports, kudos are noted, along with points to consider
which may
highlight potential areas for improvement. Reports also make note of industry
“best practices” as they relate to your current practices.
All internal audits are viewed as an opportunity to train the audited
companies’
staff in good audit presentation techniques, as well as the benefits of
a strong
quality system.
Michelle is a Certified Biomedical Quality Auditor.
“As a young company with limited resources, we
needed to turn to someone to help us with internal quality audits and
vendor audits. Our regulatory affairs consultant recommended Michelle
to us and we were not disappointed. We learned a tremendous amount from
Michelle over the last few months and this knowledge gave us the confidence
we needed to undergo our first state FDA inspection. If you work for a
small company and you're looking for someone to help with quality system
development, analysis, or auditing in preparation for a government inspection,
I would highly recommend Michelle.”
-- Christopher Daniel, Senior R&D
Manager, Rubicor Medical, Inc., Redwood City, CA