Change can bring either an opportunity or a setback, depending on how you handle it. This is true in life in general, but especially in regulated environments, where companies must contend with change constantly, such as evolving market conditions, stricter requirements, and tougher global competition.
The principle of “change control” in ISO standards, GMP regulations, and CE Marking standards is meant to help manufacturers ensure safe and high-quality products and services in spite of any changes in their product design, equipment, manufacturing materials, processes, computer systems, and all associated documentation.
How does your company manage change in processes and materials? How does your change control system measure up to ISO, GMP, and CE Marking requirements? If your company belongs to the manufacturing industry, or if you are a supplier or a services provider for this industry, this white paper will help you understand critical elements of change control.
White Paper Description
This white paper, “Change Control – Continuous Quality Improvement in FDA and ISO Environments,” discusses the following:
- The basis of FDA, CGMP, and ISO requirements for regulated companies, their CROs and suppliers
- Common challenges in implementing an effective change control process such as the following, and how to handle them
- Poor Communication
- Poor Turnaround
- Ineffective Documentation
- Training not Integrated with Change
- The advantages of automating the change control process
In this short video, quality professionals from a general manufacturer, a provider of technical products and services, and a company that specializes in bioengineered therapeutics talk about how MasterControl has helped them in complying with ISO standards.