Pharmaceutical & Biotechnology Change Control Software Systems
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: