The FDA requires medical device and drug manufacturers to train their employees. Training must occur for all types of regulated activities from internal quality management software procedures/policies to CFR requirements. The...
Regulatory Change Management Starts From Top Management
If you observe the results of various regulatory compliance surveys across multiple industries, the results of most of the surveys are pretty similar, however some of the results were quite disturbing. When asked about...
Five Steps to Select a Safety Management System

Every company has a different way of going about selecting solutions that will work best for the organization, but there are five useful steps for all companies to abide by, at least as a starting place, to effectively...
NPDES Electronic Reporting Rule
Environmental Protection Agency (EPA) signed the final electronic reporting rule which requires NPDES regulated entities to file certain reports and permit related data electronically instead of filing paper reports by...
Why Automation Means Fewer Control Violations Involving Audits
In today’s complex and regulated environment for financial institutions, there has never been more pressure on finance leaders to ensure integrity in internal auditing and controls. Boards of directors want...
Avoid Risks Through KYV or Know Your Vendors Phenomenon
I believe I have made up a new Acronym for Compliance, KYV – Know Your Vendors.
The reason why knowing your vendors is important is the associated Risks that they bring to your Financial Organization. From the Vendor...
Cutting Compliance Costs and Making Regulatory Management More Efficient Amidst Rising Regulatory Scrutiny
As compliance professionals, we are constantly trying to balance compliance and risk headcount needs with available resources ($) due to the constant and significant increases in the regulatory environment. More often than...
How are you Managing and Assessing Performance?
Companies are looking for ways to improve performance while simultaneously reducing cost and risk, and ensuring compliance. Through strategic planning, and in alignment with human resource management processes,...
How can an Integrated Risk and Compliance Management system help you avoid the same fate as Noble Energy?

It isn’t exactly news that the EPA is ramping up its NEI programs, with one of the core focuses being the Energy Extraction Enforcement Initiative and “Next Generation Compliance”. Over just a few years it more...
Integrated Governance, Risk Management, and Compliance (GRC)
Is integrated GRC an all-or-nothing proposition?
The challenge of integration often relates to cultural boundaries within an organization rather than conceptual or technical issues. GRC processes are unique in relation...
Revolutionizing the Simplicity of Regulatory Change Management
Imagine that you are about to take a drive to a place you have dreamed of going your entire life. Your suitcases are packed in the car, and all you have to do is put your key in, turn the car on, keep an eye on the dashboard...
Why Reducing Your Cost of Compliance can Save you Money
Everyone knows staying compliant saves money. It prevents hundreds of thousands of dollars in regulatory fines. Beyond that, it seems that compliance only costs money. Time, effort and dollars go into keeping...
What Would Set you Apart from Other Oil Producers?
I had a conversation with a friend of mine who lives in Midland, Texas. She’s married to an Executive in the Oil and Gas Industry and lives on property that is being drilled by a different oil company. She expressed...
Training and the FDA – What do They Require?

The FDA requires medical device and drug manufacturers to train their employees. Training must occur for all types of regulated activities from internal quality management software/policies to CFR requirements. The agency...
Think Ahead of the Curve – Regulatory Compliance Software Choice
Emergency medical technicians and medical trainers are on call at an array of sporting events, from Little League tee ball to the Superbowl. The event organizers do not anticipate participants to pull an ACL or spectators...
The ACA & Healthcare Outpatient Services Impact Perspective
“Risk Shifting”
With the adoption of the Affordable Care Act (ACA) and shift from quantity to quality-based reimbursement models, the healthcare landscape is shifting dramatically as to how providers are paid...
Report: US Power Sector CO2 Levels Down to 1990 Levels
A new NRDC report shares a positive picture about “reduced emissions” of major air pollutants like carbon dioxide, mercury, sulfur dioxide (SO2) and nitrogen oxides (NOx) by nation’s 100 electric power producers,...
Essential Elements of an Effective Whistleblower Hotline and Reporting Program
The Whistleblower Programs, established by regulators like the Securities and Exchange Commission (the “SEC”) in accordance with the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 that provides monetary...
Information Cyber Security Compliance: How Safe is Your Information?
How detrimental would an information security breach be on your organization?
Lets go back in time!
In July 2013, a data breach at the Department of Energy leaked information affected about 150,000 employees....
Key Elements of an Effective Regulatory Change Management Program
Due to the increasing number of regulations and the constant changes to those regulations, the cost and complexity of doing business is increasing. In order to stay ahead with changing regulations, organizations require...
Is Your Document Management System Effective?
One of the biggest challenges for organizations today is the ever-increasing number of rules and regulations, and the pressure to conduct business ethically. With the increasing number of policies, procedures and documents...
Proactive Enterprise Risk Management Approach
The U.S. Corporations risk management processes are under increasing regulatory and private scrutiny. The complexity, number, and velocity of risks are increasing and managing the myriad of changes in risk are becoming...
SEMS Element #2- Safety and Environmental Information
360factors announces the acquisition of Rosengarten, Smith & Associates, Inc. (RSA) environmental compliance services, environmental remediation and compliance services with offices in Austin, Corpus Christi...
Simplicity At Its Best, Using An Integrated GRC Software Solution
When it comes to performing the same types of tasks day after day, week after week, year after year, it is easy to see how easily someone can begin to overlook or skip certain procedural steps. There are many reasons...
Think Ahead of the Curve – Regulatory Compliance Software Choice
http://www.360factors.com/regulatory-compliance-software/
Emergency medical technicians and medical trainers are on call at an array of sporting events, from Little League tee ball to the Superbowl. The event organizers...
Subscribe to:
Posts (Atom)