Our CGMP Audits are available as a standard template for purchase, or on-site,
for U.S. FDA-regulated industries in the following areas:
o Medical device companies
o Dietary supplements
o Medical gases
o 21 CFR Part 11, Electronic records,
o ISO 13485 Device QMS
o ISO 14971 Product Risk
Management File / Report
o Process audits (will customize if usuable for
o Design Control
o Annual internal GMP-compliance audits
can be used "as is" for general applications, or modified by the customer (or us) for more specialized applications.
To review on-site audit capabilities, ask a question, or to order, click the link below ...
Our gereric templates are available for $495.00 each. You can place an order direct through Pay Pal by clicking
the link below and scrolling down to the bottom of that page.
Click here to order (and then scroll to bottom of that web page).
Our consulting firm specializes in cGMP auditing, training,
organizational development, and regulatory affairs consulting services that are tailored to your business, your challenges,
and your people.
Our goal is to get you implementing, not just planning.
Our work is grounded in real business issues to produce tangible, bottom line outcomes. We use the context of
your business to develop the strategies and behaviors necessary for success in today's market driven climate.
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your questions, comments or ideas to email@example.com. For issues that are of particular interest to the the community, we may publish (with your permission) your
questions along with our answers on this web site.
Click here for CGMP consulting information