Compliance Resources to Help you Stay Current

In this article, Dev Raheja, a renowned expert on Medical Devices, their software and regulatory requirements, discusses how to write effective software for medical devices, the risks, requirements and specifications.

The danger of scissor lifts being used by untrained employees was highlighted when a student died after falling from a lift at the University of Notre Dame in Indiana. Subsequently OSHA clarified its safety standard for scissor lifts.

This article summarizes the requirements, the potential hazards of scissor lift and penalties for violations.

OSHA standards for eye and face protection are essential requirements in workplaces where workers are in danger of suffering facial or optical injuries. These standards describe the kind of protective equipment employers must provide workers and the conditions under which they must be used.

This article gives the background to these standards and a summary of the requirements.

The Davis Bacon Act, 1931, is a federal law requiring that construction workers working on public projects be paid the local “prevailing” wage. The law applies to contractors and subcontractors who have taken up federally funded or assisted construction contracts in excess of $2000.

This article discusses the background to the act, gives a summary of key provisions and amendments.

An ePedigree or electronic pedigree is an electronic document that satisfies pedigree requirements of prescription drugs. While the FDA hasn’t implemented ePedigree specific regulations for the pharmaceutical supply chain, California has formulated laws regarding the use of ePedigrees.

This article describes the background to ePedigrees, current regulations governing their use and implementation status.

The Fair Packaging and Labeling Act (FPLA) of 1966 was enacted to ensure that customers are provided enough information to choose wisely among competing products. The Act is enforced by both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

This article describes the background to the act, summary of its provisions and recent amendments.

In October 2009 the Federal Trade Commission (FTC) released its final Guides Concerning the Use of Endorsements and Testimonials in Advertising. The Guides revise the FTC's initial guidelines published in 1980, providing advertisers and spokespeople with insight on how to keep their endorsement and testimonial advertisements in compliance with the FTC Act, particularly in light of new issues posed by the emergence of social media. The Guides took effect on December 1, 2009.

This article gives the background to the Guides and provides a summary of the guidelines.

The Federal Motor Vehicle Safety Standards (FMVSS) are regulations requiring the minimum safety performance for motor vehicles or items of motor vehicle equipment. FMVSS 209 was the first standard to become effective on March 1, 1967. A number of FMVSS became effective for vehicles manufactured on and after January 1, 1968.

The FVMSS are constantly updated. This article provides the background to these standards, brief overview of the most important standards and their applicability.

The Payment Card Industry (PCI) Data Security Standard (DSS) was developed to encourage and enhance cardholder security and facilitate broad adoption of consistent data security measures globally.

The PCI DSS provides a baseline of technical and operational requirements designed to protect cardholder data.

This article gives an overview of the standard including its background, reasons for implementation, applicability and requirements.

The California Environmental Quality Act (CEQA) was passed by the state of California in 1970 to institute a statewide policy of environmental protection. It acted as a system of checks and balances for land-use development and management decisions in the state. The statute was passed shortly after the federal government passed the National Environmental Policy Act (NEPA).

This article describes the background to this Act, its goals, applicability and requirements.
 

Occupation Health and Safety Assessment Series (OHSAS) 18001 is an internationally recognized assessment specification for occupational health and safety management systems. OHSAS 18001 was first issued in 1999 but was subject to review during 2006 and then issued as a revised standard on 1 July 2007. The standard aims to help organizations meet their health and safety obligations in an efficient manner. This article describes the background to this standard, summary of main provisions and recent updates.

Airworthiness standards are used to regulate the fitness of an aircraft to fly. These standards are issued by regulatory agencies such as the Federal Aviation Authority (FAA) in the US and cover all aspects of aircraft design, technology and maintenance. This article gives the definition of airworthiness, a brief overview of the most important FAA airworthiness standards and how certifications are issued.

The Japanese Financial Instruments and Exchange Law (FIEL) or the Japanese version of the Sarbanes Oxley Act (J-SOX) is the main statute that codifies the securities law and regulates the functioning of financial companies in the country. It was enacted in 2006.

This article describes the background to the law, the provisions in the law that focus on internal controls and what differentiates it from the Sarbanes Oxley Act (SOX) of the US.

The International Financial Reporting Standards or IFRS are a set of financial reporting standards, interpretation and framework issued by the International Accounting Standards Board. Worldwide, a number of countries have adopted or are in the process of adopting these standards, making it mandatory for profit making entities to comply with them.

This article primarily describes the background, requirements for financial statements and disclosures, and the status of adoption of the IFRS in various countries.

The Americans with Disabilities Act (ADA) was signed into law by President George H.W. Bush in 1990. The ADA is a landmark civil rights legislation that made it possible for around 43 million Americans with disabilities the right to public services and to apply and be considered for employment opportunities. The ADA was amended in 2008 to give broader protections to disabled workers. This article describes the background, key provisions and recent amendments to this landmark civil rights act.

The Chemical Facility Anti Terrorism Standards (CFATS) – also knows as the 6 CFR Part 27 – is a regulation published by the Department of Homeland Security (DHS) in 2007. It requires high risk chemical facilities to enhance security and establish new procedures to protect the security information of these facilities.

This article explains the regulatory requirements, various phases and impact of CFATS.

By July 1, 2011 any commercial organization either formed in the UK or having a business interest in the UK has to comply with the UK Bribery Act 2010. It is similar to the FCPA in the US but has many fundamental differences.

This article contains the details of the UK Bribery Act, its various sections, how the Act defines bribes and covered entities, the penalties and how to comply with it.

The Security and Accountability For Every Port Act or SAFE Port Act of 2006 was passed by the United States Congress on September 30, 2006 and President Bush signed the Act into law on October 13, 2006. While the majority of the Act covers the security of US ports, titles VI to VIII provide new requirements in the areas of emergency response to disasters, trucking security, trade of precursor chemicals and internet gambling regulations.

This article describes the background to the act, its various titles and provisions.

The Foreign Corrupt Practices Act (FCPA) of 1977 was created to implement stricter regulations against bribery. The act also includes requirements for transparency in accountancy under the SEC Act. It was signed into law by President Jimmy Carter and further amended in 1998 to include the International Anti-Bribery Act. The FCPA makes it illegal for a citizen or corporation of the United States or a person or corporation acting within the United States to bribe or seek advantage from a public official in another country.