QCM provides compliance experts with various backgrounds (IT, scientific, engineering, etc.) to evaluate your existing operations (GAP Analysis) and work with your team to develop and implement a solution to ensure compliance with regulatory or certification standards. We also provide certified auditors to help you maintain your compliance levels and train your team.
Compliance Assessments
- International Standards Organizations (ISO)
- Aerospace Standards (AS)
- Good Manufacturing Practices (cGMP)
- Good Laboratory Practices (GLP)
- Good Clinical Practices (GCP)
- Quality System Regulations (QSR)
Outsourcing Management
QCM can take the role of a contract liaison and handle monitoring of off-site operations to ensure compliance to regulations and contractual obligations.
Compliance Documentation & Quality System Development
QCM can review, generate, or revise:
- Standard Operating Procedures (SOPs)
- Quality Policy Manuals
- Validation Protocols
- Testing Procedures
- Deviation & Investigation Procedures
Laboratory Operations & Management
- Training Programs
- Environmental Monitoring
- Out of Specification (OOS) Procedures
- Laboratory Investigations
- Raw Materials Testing
- Analytical Method Validation, Qualification & Verification
