Quality System Complaince and Auditing

Manufacturers must ensure quality in their products while meeting customer requirements and specifications. This is only achievable in a consistent way when a Quality Management System QMS is implemented and followed. Lacking quality in the products and business operations translates into customer complaints, increased rate of returns, business losses and have legal implications risking the overall business operation. However, implementing a QMS improves organizational effectiveness, customer satisfaction, increases compliance to regulations, organizational culture and improves documentation and workflow.

Current Good Manufacturing Practices CGMP regulations enforced by the FDA provide for systems to assure proper design, monitoring, and control of manufacturing processesand facilities. It is the responsibility of each manufacturer to establish requirements for each type or familyof devices that will result in devices that are safe and effective, and to establish methods and procedures to design,produce and distribute devices that meet the quality system requirements.

QMS Auditing and Implementation Services
We assists manufacturers implementing and maintaining a Quality Management System that meets FDA requirements. We provides the initial assessment and GAP analysis to determine compliance with regulations, develops an implementation plan, provides the necessary employee training, implements the QMS, and helps to audit and monitor the system so it is properly followed and continuously improved.

Domestic and International FDA Consulting