Change Control Software for Pharma & Biotech

MasterControl Offers Pharmaceutical and Biotechnology Change Control Software Systems Help Life Science Companies Comply with 21 CFR Part 11 and Parts 210-211 Quality Standards

In the FDA regulatory environment, the concept of change control is closely interwoven with compliance. Companies that produce FDA-regulated products are expected to establish Pharmaceutical and Biotechnology change control software systems 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 a quality control unit.

Feel free to download information below about our change control solution:

Ensure Compliance by Digitizing Change Control