Change is inevitable. That is why the concept of change control is critical, especially in regulated (FDA, EMA, Japan) and ISO-manufacturing environments, where inappropriate or "uncontrolled" changes could affect the safety of products and directly impact public health and safety.
Life science and manufacturing companies realize that an effective change control process is key not only to compliance, but also to continuous quality improvement. It can lead to increased customer satisfaction and prevent product recalls and regulatory violations.
White Paper Description
This white paper, "Change Control: Continuous Quality Improvements" prepared by MasterControl Inc. includes discussion of:
- Definition of change control in the context of life science and ISO environments
- Specific regulatory requirements and ISO standards pertaining to change control.
- Elements of a typical change control process
- Common problems pertaining to change control - and solutions for optimizing the process