by David Lohbeck As an assessor, I am often asked the following question: “Is a calibration certificate issued from an ISO/IEC 17025-accredited laboratory always acceptable?” My answer: “No, it may not be.” Read on to […]
by Walter Nowocin There are many regulatory requirements that bio-medical companies need to follow; however, FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures is one of the more obscure and misunderstood of the […]
by Christopher L. Grachanen It is most gratifying to see a grass roots initiative spanning many years come to full fruition. Such is the case for U.S. Department of Labor’s formal recognition of calibration practitioners. […]
We have all heard this before: Think outside the box! But this is easier said than done. It is especially difficult to notice your own blinders because we all see things from our own point […]
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