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Verification and Validation Protocols

A well-written protocol includes the following information:

Sample size and justification for sample size
Acceptance criteria clearly defined
Steps to be taken in the case of test failures
Description of data analysis
Complete listing of equipment to be used
Training requirements for associates who will perform the testing

Welcome to ADVQSS

Welcome to ADVQSS website. ADVQSS is a full service consulting company specializing in the medical device industry. Our goal is to offer clients timely, cost-effective solutions to quality system compliance issues. We develop quality systems for start up companies or work with you to improve your existing quality system. ADVQSS clients include 1 person companies as well as Fortune 100 organizations.

Many times, an organization’s automatic response to compliance deficiencies is to generate another piece of paper—SOP, work instruction, or form. The cumulative effect is a quality system driven by paper (or electronic documents) and an organization swimming in documents—many of which employees aren’t even aware exist.

When developing a quality system, ADVQSS works closely with the client to provide documents that are succinct, appropriate for the intended user, and provide a foundation for efficient and compliant processes.

ADVQSS is here to help, whatever your quality system compliance needs are.

Everything should be made as simple as possible, but not one bit simpler.
Albert Einstein, (attributed), US (German-born) physicist (1879 - 1955)

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ADVQSS is a full service consulting company founded by Michelle Johnston specializing in the medical device industry. Its’ goal is to offer clients timely, cost-effective solutions to quality system compliance issues.