Quality Control

Quality

MMS is a quality driven company and our Quality Management System (QMS) reflects and implements the requirements of the ISO 9001:2008 and ISO 27001:2013 International Standards. MMS was founded on the basis of quality as one of the first CROs to be ISO 9001 certified for all of its service offerings. We have developed the infrastructure to provide electronic document management and the processes to ensure clear communication and compliance between regulator and client. In addition to meeting the agency requirements for electronic systems and security, the MMS IT systems and processes are ISO 27001 certified. Intellectual Property (IP), confidentiality and security protection for projects are maintained within MMS’ Information Technology Infrastructure Library (ITIL) compliance policy.

Our QMS functions across the medical / regulatory writing, regulatory affairs, clinical programming, biostatistics, data management and medical review / pharmacovigilance services. As a result, quality is a focus of all training; and, our QMS certifications demonstrate that quality is not just a metric at MMS, but drives our work at every stage of the project life cycle.

We stand by the services we provide and review our processes on a routine basis to ensure adequacy and fulfillment of client expectations. Preparing a quality deliverable is our commitment and responsibility. If corrections or re-work are requested, our team will fulfill the request without increasing the project budget.

Quality Management System (QMS)MMS’ quality management system reflects and implements the requirements of the ISO 9001:2008 International Standard (ANSI/ISO/ASQ Q9001-2008). Our quality management system functions across the medical/regulatory writing, regulatory affairs, clinical programming, biostatistics, data management and medical review/pharmacovigilance services provided to the pharmaceutical, biotechnology, and medical device industries. MMS employees are trained on these policies in order to enhance customer satisfaction, including processes for continual improvement and the assurance of conformity to customer and applicable regulatory requirements.

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