Product Quality/Safety

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easy2comply Risk Management software

easy2comply Risk Management software solution enables efficient operational/ enterprise risk management in order to improve business processes and performance and simplify regulatory compliance. easy2comply allows you to identify, measure, control and manage operational/ enterprise risk by documenting your processes, risks and controls, accumulating and quantifying loss events, and providing management insight via reports, dashboards, heat-maps, what-if simulations and remediation plans. The software provides a full set of functionality, best practices, built-in work flow and a decision support system for ORM optimization. easy2comply’s unique architecture enables building a common framework and repository for multiple GRC processes, while allowing each individual project to be managed separately according to its own time frame, functionality, methodology and work flow. easy2comply’s singular software architecture provides the technological basis for enabling GRC convergence and a truly integrated GRC framework.

  • IT.12 - Finance/Treasury Risk Management
  • IT.26 - Risk Management
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Mitratech Technology Provider
SAS Institute, Inc. Technology Provider
Why is GRC important? blog

I have been blogging about what GRC is, advocating the definition developed by the Open Compliance and Ethics Group, OCEG (see this and subsequent posts). But, I haven’t really talked about why the concept of GRC has value.

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GRC in Chile - New Challenges blog

MIRAGroup Chile is in charge of development EGRC Concepts in multiples industries in this country. Our first purposes is help companies to understand this new way to manage Risk, Governance and Compliance as an integrated process.

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Cura Software Solutions Technology Provider
Corporate Integrity LLC Advisory and/or Audit Firm
Deloitte Advisory and/or Audit Firm
FDA, PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (2004) resource Agency Guidances OCEG Reviewed
This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has developed an innovative approach for helping the pharmaceutical industry address anticipated technical and regulatory issues and questions.
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