Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

KeyMark ISMS wields the global standard for risk management and cyber-resilience An ISMS that’s ISO certified should be ...

The risk assessment tools in the ANSI/ASSE/ IEC/ISO 31010 standard were of particular interest. It seems that many companies in the Gulf region are requiring their risk management and safety staffs to ...

Risk management is an integral part of any organization's operations. It involves identifying, assessing, and mitigating risks that could potentially impact the organization's objectives. Two widely ...

ISO 31000:2018 is a shorter and clearer guide to help organizations improve planning and decision-making through the use of risk management principles. The International Organization for ...

Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. ISO ...

ISO 31000 is an international standard for risk management that provides a framework for identifying, assessing, and managing risks across an organization. The ISO 31000 Lead Risk Manager ...