Quality System
A Quality System is essential to meet regulatory requirements such as those set forth in the U.S. Quality System Regulation (QSR) and International Standards Organization (ISO) guidelines. Foresight Regulatory Strategies, Inc. assists clients in the development, implementation and maintenance of Quality Systems by providing the following services:
• Assistance in the development of Quality System processes and documentation necessary to ensure compliance with the appropriate worldwide standards and regulations
• Evaluation of existing Quality Systems to identify weaknesses or inefficiencies and provides guidance in the resolution of these issues
• Auditing to assist in preparation for FDA inspections and ISO Quality System audits and guidance for clients during those inspections and audits
• Advice on planning and/or implementing corrective and preventive actions in response to regulatory authority audit/inspection observations or other communications
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