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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.

10 Interesting Websites that have nothing to do with quality systems
Here they are, in no particular order:

www.10best.com
By city, recommendations for hotels, restaurants, nightlife, etc. The anti-Frommers.
www.uncommongoods.com
Look no further for that unique gift. The alternative to mall shopping.
www.ranchostyle.com
Check out remodeled mid-century modern (1950s) homes in Long Beach, CA. One more thing to like about California!
www.alexfritzglass.com
Alex is our neighbor, friend, and a talented glass blower. His wine glasses are gorgeous—check them out.

www.seatguru.com
Don’t get caught in the airline seat that doesn’t recline. A website for airplane configurations by airline.

www.quotationspage.com
You’ll never be at a loss for words again.

www.npr.org/programs/specials/lists/sedaris
Readings from the hilarious, best-selling author David Sedaris on NPR. He is the funniest person on the planet.

www.rangemart.com
Okay, maybe I’m biased. My husband owns Range Mart. You probably won’t have much use for his products unless you own a driving range, but you can order really durable mats for that person who’s crazy about golf.

www.eyespyla.com
The 411 on things to do in Los Angeles.

www.thesmokinggun.com
Large collection of public documents, celebrity mug shots, etc.

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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More Links:	10 Interesting Websites
Advanced Quality System Solutiions is a full service consulting company founded by Michelle Johnston specializing in the medical device industry. New quality system development or solutions to existing compliance issues—FDA QSR, ISO 13485, 93/42 EEC, Canadian Medical Device Regulation.