Part 11 Compliance

As computer usage became more mainstream, especially as a way to store records, the FDA received a request from various industries for guidance on the use of electronic signatures and submissions to the FDA.  The FDA’s response to this request was to issue 21 CFR Part 11 in 1997, which covers electronic signatures, records and…

Latest Spore News to be Published in Italian

  The latest edition of Spore News, Mesa’s in-depth biological indicator newsletter, is circulated worldwide to a large audience of industry professionals, Mesa partners and end users. The latest installment titled “Using Replicate BIs to Evaluate Biodecontamination Cycles in Isolators” written by Garrett Krushefski from our Bozeman, Montana manufacturing facility was distributed in July and…