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Validation Planning

If you are planning to deploy and use your technology in an environment governed by the FDA Code of Federal Regulations, then Computer System Validation (CSV) will be an integral part of your technology initiative.

Since most, if not all, technologies are deployed with an electronic data component, 21 CFR Part 11 compliance must be addressed as well as predicate 21 CFR Part 210 and 21 CFR Part 211.

Bluewater Technology Partners has over 18 years of CSV experience and can assist with any phase of your validation effort as well as assess the state of your firm's validation and compliance status.

We can support the following activities/deliverables:

Please contact us for specifics.

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