Change Control Management Software
Managing change is crucial in the life sciences industry. Pharmaceutical companies operating in GMP environments are required to disclose all changes. All changes must be approved by authorities before they can be implemented. Only after receiving clearance from regulatory agencies such as the US FDA and MHRA would a pharmaceutical organization make modifications to a current product.
In pharmaceutical, biotech, and life sciences firms, managing a change might be a challenge if the process is reliant on paper. In a cGMP-regulated setting. The surveillance of regulatory requirements has a significant influence on quality. As a result of human mistakes, unintended repetition, lack of traceability, and many other issues, paper-based or manual change control solutions slow down turnaround times. As a result, productivity and product safety or quality might be adversely affected.