In the life sciences industry, quality management is a multidimensional issue, covering more than just verification that a finished product meets certain expectations. As a component of regulatory standards, quality management requires a system for controlling, monitoring, and verifying any activity or process that could affect product conformance. From the manufacturing floor to the chairman’s office, the importance of having full global alignment with a culture of quality has never been more important.
With over 30 years of expertise in life sciences consulting, Maetrics works collaboratively with clients to guide quality management strategies. Our team possesses the experience to devise customized solutions to specific quality management issues and can build locally focused or company-wide strategies for meeting regulations within the biotech, pharmaceutical, diagnostic, and medical device fields.
Providing Quality Management Expertise & Customized Training
Maetrics’ life sciences consulting services cover the full range of quality systems initiatives, including:
- Internal process and quality system audits/assessments
- Pre-certification audits
- 21 CFR 820 Regulations & compliance
- Document control
- Design control
- Manufacturing and production processes
- Standard Operating Procedure (SOP) development
- Supplier quality and purchasing controls
- Labeling consistency and accuracy
- Complaints, Corrective Action/Preventive Action (CAPA), Adverse Event (AE), Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) processes and systems
Maetrics also provides customized training based on an organization’s requirements, to ensure teams are utilizing the current best practices. We offer instruction on areas such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Quality System Regulations, ISO 13485 & 14971, Medical Device Regulation (MDR) & In Vitro Diagnostic Medical Device Regulation (IVDR) compliance, auditing, validation, specific regulations, and related quality management topics. Whether sessions are delivered via classroom instruction or a learning management system, our training goes beyond theoretical approaches and provides instruction that’s directly applicable to a client’s business needs.
Ensuring that pharmaceutical and biotechnology products, as well as medical devices, meet a high level of quality is a full-scale endeavor. The processes, testing, and documentation behind those products must follow a consistent plan and meet current regulations. Each member of an organization, from executives to resource suppliers, plays a role in how quality is factored into a company’s operations, and Maetrics can help guide your company to making quality a repeatable and ongoing standard.
Have a Question?
Contact us to learn more & find out how Maetrics can solve your regulatory or compliance issues.