FDA/ISO White Paper
Titled "Change Control - Quality Improvement in FDA & ISO Environments," this white paper discusses what FDA inspectors and ISO auditors consider one of the most critical regulatory principles. The white paper includes definition of change control in the context of FDA and ISO environments, specific FDA 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. The white paper was prepared by MasterControl Inc., a leading software provider for regulated companies. Information: www.mastercontrol.com.