Regulatory Compliance 101
Guide to Corporate Regulatory Compliance -- HIPAA, SOx, EPA, OSHA, RoHS, ISO, GMP, OFAC

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Compliance Terms & Acronyms

CFR - Code of Federal Regulations
Set of standards set forth by the U.S. government that apply to many industries. The EPA, GMP and OSHA all use CFR regulations to define regulatory compliance in those industries.

EPA - Environmental Protection Agency
U.S. agency that deals with environmental compliance issues for clean air and water as well as waste reduction and disposal. Title 40 CFR, ISO Standard 14001 and RoHS are the most pertinent regulations for environmental compliance.

GMP - Good Manufacturing Practices
Deals with manufacturing quality and public safety issues for the food, biotech, pharmaceutical, and cosmetic industries. Title 21 CFR, FDA Part 11 and ISO 22000 are the most pertinent regulations for GMP compliance.

HIPPA - Health Insurance Portability and Accountability Act
Deals with medical patient recordkeeping, security and privacy issues for the healthcare and medical billing and health insurance industries.

ISO - International Standards Organization
Deals with quality control and management standards that apply to most companies. ISO 9000, 9001, 14000 and 14001 are the most pertinent regulations for ISO compliance.

OFAC - Office of Foreign Assets Control
Deals with identity verification for the banking, insurance, credit and travel industries. Related to Patriot Act compliance.

OSHA - Occupational Safety and Health Administration
Deals with workplace health and safety compliance issues. Title 29 CFR is the most pertinent regulation for OSHA compliance.

SOx - Sarbanes Oxley
Deals with financial compliance and internal accounting disclosure issues for publicly-traded companies. The Securities and Exchange Commission (SEC) sets the mandates for Sarbanes Oxley compliance.

RoHS - Reduction of Hazardous Substances
Deals with environmental compliance issues for the electrical and electronics manufacturing industry. RoHS is an EU initiative, but impacts many countries.



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