Project-Based Services
Often our clients need a quick solution from a large team of experienced resources. Maetrics™ utilizes risk-based strategies, methods, approaches, and software to rapidly assess a situation and deliver an innovative solution to meet your business needs. Our experience spans a wide variety of manufacturing, laboratory, and clinical (cGxP) environments including quality management systems consulting, all forms of validation, and regulatory solutions that encompass 21 CFR Part 210, 211 820, 106, 107, 110; ISO standards including 13485; the new guidance for 21 CFR Part 11; and HIPAA. We provide the following core services:
- Risk based regulatory and quality systems advice, strategies, audits, and assessments
- All types of validation services, solutions, and outsourcing, including: master plans, process/product, equipment, software (CSV), laboratory, manufacturing, cleaning, clean room, facilities, and utilities validation
- New product support for 510K, PMA, NDA/ANDA, and other regulatory submissions
- Customized regulatory and quality training services including all FDA, ISO, ICH, GHTF, and GAMP4 guidelines, regulations, and standards
- Technology development and enablement services for custom and package software
- Vision Software™ – performance management software that provides enterprise-wide visibility to compliance and continuous monitoring of quality metrics utilizing Vision SoftwareTM dashboards to monitor performance, metrics, and balanced scorecards in regulated environments
- Our Approach / Our People
- Project-based Services
- Experience / Program & Project Management
