Inexpensive FDA-Compliant Change Control

I-PROCESS can quickly, easily and inexpensively help you comply with most government and industry regulations for change control and electronic signatures, while simultaneously saving you money and improving efficiencies. Too good to be true? Not this time!

I-PROCESS can help you comply with all of the following FDA guidelines:

FDA Design Control Guidance (21CFR820.30)

FDA Good Manufacturing Practices / Quality System Regulation

FDA Electronic Records, Signatures (21CFR11)

FDA Premarket Notification and Approval (501K)

FDA Talk Paper on Enforcement

Request our white paper "Design Control Solutions for Medical Device Manufacturers" by emailing or calling Paul Stevens at 503.223.9152 ext.130.