Regulating manufacturing processes in the medical device industry is challenging. But process signature verification can help manufacturers get a handle on problems before they get out of control.

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. A year’s worth of FDA warning letters suggest ...

The U.S. Department of Agriculture’s Process Verification Program could provide an avenue for firms to certify the veracity of non-GMO claims without indirectly suggesting that genetic engineering is ...

Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming. The ...