Quality Assurance Experience
MMS is independently certified for Quality and Information Security (ISO 9001: 2008 and ISMS certifications). MMS offers a highly experience QA team and an organization that was founded on quality principles and continues to emphasize strength of process and expertise in all interactions with our clients and all deliverables we produce. Where of interest to our sponsors, MMS can offer remote auditing services. MMS GCP auditors complete >20 investigator audits each year and >10 process evaluations (sponsor, CRO/vendor or in country affiliate office).
21CFR Part 11
MMS utilizes a management system which integrates both Quality Management and Information Security Management. This ensures that our systems meets customer requirements, interested parties requirements and applicable legal and regulatory requirements.
MMS has established policies to meet 21CFR Part 11 Electronic Records and Electronic Signatures. IT systems are evaluated and validated as per this policy and software validation procedures. Part of QMS & ISMS various policies, procedures and training modules are established and implemented for ICH & FDA Guidelines, and GCP Training. We have a robust Document Management System and detailed Document and Record Control procedures. Our Regulatory group reviews updates to FDA and ICH Guidelines and provides additional training and procedure updates as required.
MMS is also third party certified to ISO 9001:2008 and ISO 27001:2013, we have processes in place to cover all applicable elements of these ISO standard. Our internal Quality group performs audits throughout the year to ensure that these standards are being met. We are audited by an accredited third party registrar to maintain our ISO certification. The MMS Management Team is committed to ensure compliance and continual improvement of these management systems.
QA Error Identification
Internal MMS procedures involve the incorporation of a unique QA evaluation method that was established to measure the quality of all deliverables during Quality Control. The current allowable sigma level for all final deliverables are 4 sigma level (allowing 6210 Defects per million opportunities). This is equivalent to an error rate of 0.00621 defects per check point per page (Assume 6 defects, 100 pages, 10 check points). Deliverables that do not meet this level of quality are reviewed and appropriate corrective actions are implemented.