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Tamar June
Companies struggling to comply with the FDA’s myriad electronic recordkeeping regulations should take a deep breath and follow it up with a long, careful look at the FDA’s actual GxP and 21 CFR Part 11 rules. After a careful reading of the admittedly long and sometimes dry rules, it should become…
Tamar June
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of…
BSI
More than a decade ago, Osteoimplant Technology Inc. provided the orthopedic prosthesis for a complete hip replacement for Mikhail Lavrovsky, one of the most famous lead dancers with the Bolshoi Ballet. He was able to dance with the replacement and continued to make appearances around the world.…
Tamar June
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of…
Quality Digest
Our BioMed Community is under Construction. Check back soon. Our launch date will be Jan. 26, 2005