Regulatory Submission Tracking Software

MasterControl's Electronic Regulatory Submissions Software Systems help Automate FDA Electronic Submissions in a 21 CFR Part 11 Compliant Manner

In the FDA environment, the concept of change control is closely interweaved with regulatory compliance. FDA-regulated pharmaceutical companies are expected to establish a change control procedure as a way to improve product quality and safety and to ensure compliance. Under the Current Good Manufacturing Practice (CGMP) regulations outlined in 21 CFR Parts 210-211, pharmaceutical companies are required to control any change to established processes – meaning the change has to be recorded, reviewed, and approved by the quality control unit. MasterControl provides electronic regulatory submissions software to help pharmaceutical companies to comply with the regulations accordingly.

The New Digital Pathway for Regulatory