QMSCore | Compliance Management Systems, Inc.

About Us

Passion. Experience. Diligence. Delivering trusted compliance solutions to the life sciences industry.

Our History

Compliance Management Systems, Inc. (CMS) was founded in 2007 by Marc Monette, a seasoned expert in GxP data integrity, computerized system validation (CSV), and quality management systems. Since inception, CMS has supported pharmaceutical, biotech, medical device, and CxO organizations across North America, Europe, Asia, and beyond.

Our mission is to enable life sciences companies to maintain compliance agility, efficiency, and effectiveness through scalable, risk-based approaches to data integrity and system validation.

We specialize in assessments, audits, remediation planning, and long-term subscription-based CSV program management aligned with GAMP 5 and CSA principles.

Our Services

Comprehensive compliance consultancy and tooling for life sciences organizations under increased regulatory scrutiny.

CSV Program Subscription

Full outsourcing of CSA and GAMP 5-aligned CSV activities in collaboration with your validation team.

• Establish and maintain CSV program
• System Risk Assessment & Inventory
• Remediation planning
• Change control support
• Periodic review & updates

Data Integrity Consultancy

End-to-end assessment and remediation of data integrity gaps across your organization.

• DI maturity assessments
• Root cause analysis
• CAPA planning and execution
• Audit readiness
• Training and SOP development

GxP Compliance Audits

Independent audits of quality systems, CSV practices, and data governance frameworks.

• Internal and external audit support
• Vendor audits (QMS & lifecycle docs)
• Regulatory inspection prep
• Audit report & follow-up
• Corrective action tracking

Subscription Supplier Management

Ongoing vendor oversight with ASQ-Certified Quality Auditors evaluating QMS and product documentation.

• Vendor QMS assessment
• Lifecycle document review
• Risk-based classification
• Audit report generation
• Ongoing monitoring

CSV Project Services

Contract-based CSV execution for new systems or major changes to existing ones.

• URS, FRS, SRS development
• Test script creation & execution
• Traceability matrices
• Deviation management
• Validation summary reports

Quality Management System (QMS) Improvement

Implementation, optimization, and audit of QMS frameworks across life sciences.

• Gap assessments
• SOP development
• Training programs
• CAPA system enhancement
• Management review support

Regulatory Strategy & Readiness

Proactive planning to meet FDA, EMA, MHRA, and other global regulatory expectations.

• Inspection readiness programs
• Mock audits
• Response drafting (483, Warning Letters)
• Regulatory intelligence
• Compliance roadmap development

Training & Workshops

Customized training sessions on data integrity, CSV, audit techniques, and quality culture.

• Onsite and virtual delivery
• Role-based curricula
• GxP refresher courses
• Leadership workshops
• Audit effectiveness training

Our Leadership

Decades of experience in quality, compliance, and data integrity across global life sciences.

Marc Monette

President & Principal Consultant

Marc has been a leading voice in GxP data integrity, computerized system validation, and quality management for decades. He has consulted with pharmaceutical, biotech, and medical device companies across the United States, Canada, Europe, China, and India.

A frequent speaker at industry conferences, Marc emphasizes a process-driven, risk-based approach to compliance that balances regulatory requirements with operational efficiency.

Education & Certifications

• MBA, University of Toronto
• B.E.Sc. Mechanical Engineering, University of Western Ontario
• ASQ Certified Software Quality Engineer (CSQE)
• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)
• ASQ Certified Quality Auditor (CQA)
• ISACA CRISC – Certified in Risk and Information Systems Control

Let’s Chat

Whether you're facing a regulatory challenge, need audit support, or want to outsource your CSV program, we’re here to help.

Contact Information

Location: 1300 S Bristol St., Suite 222, Santa Ana, CA 92704

Email: info@qmscore.com

Office Hours: Monday - Friday, 9AM - 5PM

We offer free consultations to discuss your needs, goals, and budget. Our response time is typically within one business day.

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