In hopes of cutting administrative costs and streamlining the amount of time it takes to get new drugs to consumers, eight global pharmaceutical 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.
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.
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.
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.