ISO 9001:2015   |   ISO 27001:2013

Inspection Readiness and Preparations

Our compliance teams have prepared many sponsors, sites and vendors for external audits and health authority inspections through the use of  a variety of innovative tools at our disposal.  As former health authority personnel, industry experts, and senior quality assurance specialists, our employees can offer a comprehensive pre-inspection review of your facilities, processes and documents. Uncovering and addressing findings at this juncture gives your firm the ability to respond confidently to a health authority inspection or investigation request, potentially preventing official observations and actions.

Having MMS employees  who served as  regulatory agency investigators, we are in the unique position to offer mock regulatory health authority inspections.  Whether it be enhancing your comfort with the types and volume of questions asked during an inspection, or ensuring your staff is prepared to provide the documents which will be requested, a mock inspection can prove invaluable.  MMS can help you to ensure your teams are “inspection ready” by conducting mock inspections at your plant/facility, third party vendors, suppliers, laboratories or contract manufacturers.

Process, document and facility audits can also be conducted in conjunction with mock inspections, providing the added benefit of uncovering potential Observations and allowing their  resolution before the actual health authority inspection.  You can also arrange for conduct of pre-inspection audits or mock inspections for your third-party vendors, suppliers, laboratories, or contract manufacturers for the added security of knowing that all inspection and compliance potential areas are under control.

Where time or budgets are limited, MMS also offers inspection readiness through remote web-based techniques including training

Regulatory Submission Support Based on Strong Science and Strength of Process. The difference is in the data!