16 January 2004

Meeting Stringent 21 CFR Part 11 and GxP Standards - US FDA

What Should You Do Now?

The FDA’s guidance will provide assistance to organizations
in the development and implementation of their risk-based
compliance approach. For organizations that have already
initiated Part 11 and risk-based compliance programs, the
guidance can be used to streamline and focus efforts on
areas that are most significant from a quality, safety and
efficacy perspective. The guidance should prompt
organizations to evaluate whether:

1. The organization has a risk-based approach to
determine areas that are the most significant from
a product quality, safety and efficacy perspective;

2. Existing Part 11 efforts are focused on processes and
systems that pose the highest risk to product quality,
safety and efficacy;

3. The organization has a consistent process to document
risk assessment decisions and a method of linking these
decisions to the compliance and validation approach
for a particular process or technology area;

4. Related compliance efforts such as HIPAA, Part 11,
Sarbanes-Oxley and others are aligned to achieve the
most efficient and effective compliance approach;

5. The organization is positioned from a people, process
and technology standpoint to realize the potential
benefits that could be realized by applying the
principles outlined in the guidance documents.

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