Biotechnology

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BWise Technology Provider
Corporate Integrity LLC Advisory and/or Audit Firm
Deloitte Advisory and/or Audit Firm
easy2comply Technology Provider
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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FDA, Import and Export Guidance Documents resource Agency Guidances OCEG Reviewed

The Food and Drug Adminstration's web site for import and export guidance information.

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Fraud Risk Management in Life Sciences Companies (Deloitte, Rev. 2009) resource Articles Member contributionOCEG Reviewed

This paper discusses common fraud schemes within the life sciences industry and offers effective strategies for mitigating fraud risks.

Authors: Bob Clarke and Mark Stehr

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Japan, Pharmaceuticals and Medical Devices Agency (PMDA) resource Agency Web Sites Member contributionOCEG Reviewed
PMDA, an incorporated administrative agency, is involved with pharmaceuticals and medical devices from development through postmarketing use.
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Journal of Commercial Biotechnology resource Books / Publications OCEG Reviewed

Published quarterly by Palgrave Macmillan.

The Journal of Commercial Biotechnology is an international peer-reviewed, professional journal which focuses on the commercial, legal and regulatory issues affecting biotech, biopharmaceutical, agrochemical and environmental companies.

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Learn from the experience of others and share your experience! blog

Have you ever asked your peers or professional colleagues what risk management or compliance tools they use?  We value the ground well tread because we know that learning comes from making mistakes.  How would you like to know what 1000's of your peers are saying about GRC ven

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