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CAPA Verification of Effectiveness Checks

To ensure that each verification of effectiveness check is complete and appropriate, consider the following:

• The CAPA record should have a section to record a description of the method, when it will be done and who will do it. Failure to record this information up front makes it appear that this activity wasn’t considered.

• Some effectiveness checks may require an extended monitoring period. However, each check should be timely and commensurate with the nature of the CAPA.

• An internal audit may not be the best method, especially if the CAPA is complex or technical in nature and not easily understood by the auditor.

• If the CAPA required validation prior to implementation, ask yourself if an effectiveness check is required. (hint: no). Document your rationale on the CAPA form.


Welcome to ADVQSS

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

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.
Unlike many consultants, I do not subscribe to the “more is better” theory. I’ve seen 70 page Quality Manuals that are so generic that they do not even state the quality system scope. ADVQSS provides clients with a Quality Manual typically 8-10 pages. Other quality system documents are written in a similar fashion—succinct and appropriate for the intended audience.

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.

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