November 2010 Posts

The Three-Legged Stool: Governance, Risk and Compliance (GRC)

The Three-Legged Stool: Governance, Risk and Compliance (GRC)

Guidelines for governance, risk and compliance (GRC) affect nearly every company in every industry today, with different areas of scrutiny in varying areas of operations. Regardless of industry, however, successful companies reach corporate accountability by proving to stakeholders that their business is reliable, compliant, and sustainable.  To achieve this, a unified GRC strategy that guides people, standardizes processes, and integrates technology to embed governance, risk, and compliance must be established. (more…)

Five Key Essentials for a Good Electronic Document Management System

Organizations need to accommodate continuous improvement activities, daily operations and change that correspond to document content – administering all these documents, making it accessible and keeping it current. Today’s regulated companies must track and manage all documents from different departments, plant locations, customers, vendors and regulatory agencies. To be competitive, a firm must automate its handling of documents with an effective electronic document management system (EDMS). EDMS is a set of products and services that lets users electronically store, locate, retrieve, share and track documents. (more…)

FDA tells Drug Makers, “Just the Facts, Ma’am”

Beginning in March 2011, companies testing experimental drugs or medical products will be required to inform the FDA within 15 days about serious risks and adverse reactions that arise during clinical studies (FDA, Sept. 2010). This isn’t anything new … the FDA just wants to make it simpler. The final rule is a revision of a proposed rule that was issued in March 2003. Apparently, many companies were piling information on the FDA in droves, making it harder for the agency to sift through the data quagmire to find the necessary information. Wanna make it easier on yourself and the FDA? Think Electronic Regulatory Reporting.
(more…)