Today any life sciences enterprise inevitably faces ongoing risks to finances, products, data, equipment, property, and personnel. With each passing year, the knowledge needed to handle risk management is expanding, and successfully having avoided business and compliance risks in the past doesn’t necessarily mean that an organization can consider itself safe from current or future threats. As if that weren’t enough, enterprises are also expected to be compliant with ISO 14971, and ISO 13485, the latest risk management standards.
As a global leader in quality risk management consulting, Maetrics provides proven strategies that allow organizations to manage risks in a practical, effective, and proactive manner. Whether the focus is on pharmaceuticals, biotechnology, medical devices, or diagnostics, our overarching goal is to help each client become risk-adept and agile.
Controlling Risks While Improving Overall Performance
Maetrics employs a comprehensive and collaborative approach that enables risk management strategies to be implemented as an inherent, vital part of product life cycles, supply-chain operations, and quality management systems all designed to deliver patient safety. Our extensive experience in compliance and quality management provides a unique insight into managing the risk profiles in today’s life sciences environment. Recognizing and mitigating risks early on, and not as a post-production afterthought, will ensure that risk controls are in place throughout a process to verify that specific activities operate according to plan and are proven to be effective.
Whether focusing on compliance, security, or other issues, our team will develop risk plans and devise a customized strategy through the following procedures:
- Analyzing & identifying levels of risk: We assess a company’s quality operations and determine the probability of occurrences that may cause harm to people, property, and environment. Having a comprehensive assessment of risk will lay the groundwork for the appropriate strategies.
- Devising a strategy & putting it in action: After our initial assessment, our team will create a comprehensive risk profile and develop an effective, sustainable solution that results in proper risk mitigation.
- Monitoring & reporting: Once a strategy is under way, we’ll monitor its effectiveness and/or provide reports on progress or any necessary adjustments.
Risk management, compliance, and quality monitoring are deeply interconnected within the life sciences industry. By partnering with Maetrics, clients will meet their risk management regulatory requirements, stay up-to-date on potential hazards, and make data-driven decisions to improve risk avoidance and mitigation, all while achieving business goals and preparing for future growth.
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Contact us to learn more & find out how Maetrics can solve your regulatory or compliance issues.