Quality Compliance Services for the Life Science Companies
Achieving Compliance, Protecting Patient Safety
Quality issues lie at the heart of today’s drug shortages, one of the biggest challenges in the healthcare industry. They are best addressed by a holistic approach to compliance, where a quality management system (QMS) is not just a requirement but a tool for delivering high-quality medicine and better patient outcomes. This holistic approach not only benefits patients by improving their health and keeping them out of harm’s way, but also generates opportunities for companies that produce safe, effective medicine.
- Overcoming GMP Compliance Myths that limit patient and business outcomes
Despite the proven benefits of a strong quality management system, many life sciences companies’ implementation of a QMS continue to fall short on reaping the potential benefits. Why? First, they underestimate the impact of a robust QMS on the business. Second, they don’t have the expertise to stand up a successful QMS.
A successful implementation requires dropping the notion that QMS is “just paperwork”, “a box to check”, or “a problem we won’t own if we outsource.” Preventing these misconceptions from impacting the business and the patients it serves requires using risk-based methods on the one hand and quality metrics on the other. Risk-based methods include critical thinking, thorough supply chain management, and standing up data-driven QMS. By turning quality into a business imperative, QM metrics can help gauge implementation success and uncover improvement opportunities.
- Quality and compliance expertise that removes the guesswork
GxP-CC’s experts have extensive experience in tackling the challenges of building and maintaining a quality management system. Whether you need to build a new QMS or improve an existing one, we can help you stay compliant with regulations and guidelines like ICH Q9 and Q10. In doing so, we take into account your systems, processes and procedures, and, most important, your culture. As experts with experience from around the world, we know the science and regulations as much as we know how to manage the human and cultural dynamics. We know how to conduct quality oversight audits and self-assessments as well as we know how to engage your most important stakeholders. And, we can optimize your processes while standing up an electronic QMS.
- Quality and Compliance Implementation with all the benefits, none of the risks
GxP-CC has helped clients around the world develop sustainable Quality Management Systems.
We offer Quality and Compliance services for every phase of the product life cycle, from Good Clinical Practices in research phases through Good Manufacturing Practices. Our quality and compliance services include:
- Trainings and Workshops beyond “read and understood”
- Support in third party management
- Audits and assessments
- Audit preparation
- Gap Assessment of the QMS, e.g., against 21 CFR 211, EU GMP and ICH Q10
- Medical Device quality management, following ISO13485 and 21 CFR 820
- Quality Metric definition
- Digitalization and centralization of QMS tasks
- Implementation of eQMS solutions
Schedule a call now to learn more about how our Quality Compliance services can support your needs and enable your step forward reaching a modern and sustainable QMS.