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ISO 13485. ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
ISO/IEC 27001 is an international standard to manage information security. The standard was originally published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) in 2005, [1] revised in 2013, [2] and again most recently in 2022. [3] There are also numerous recognized ...
PII Controllers generally demand evidence from PII Processors that the PII Processors’ privacy management system adheres to applicable privacy requirements. A uniform evidence framework based on international standard can greatly simplify such communication of compliance transparency, especially when the evidence is validated by an accredited ...
Electronic common technical document. The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for ...
Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations. [1] Due to the increasing number of regulations and need for operational transparency, organizations are increasingly adopting the use of ...
Records management, also known as records and information management, is an organizational function devoted to the management of information in an organization throughout its life cycle, from the time of creation or receipt to its eventual disposition. This includes identifying, classifying, storing, securing, retrieving, tracking and ...
e. Governance, risk management and compliance (GRC) is the term covering an organization's approach across these three practices: governance, risk management, and compliance. [1][2][3][4] The first scholarly research on GRC was published in 2007 [5] where GRC was formally defined as "the integrated collection of capabilities that enable an ...
A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software -based solution with features that support a modern laboratory 's operations. Key features include—but are not limited to— workflow and data tracking support, flexible ...