The Most Important Compliance Best Practices You Need to Know

'Internal Control: Guidance to Directors' ("the Turnbull guidance") sets out best practice on internal control for UK listed companies, and assists them in applying section C.2 of the UK Corporate Governance Code.

This article outlines best practices that companies can follow in order to comply with the Turnbull Guidance.

OSHA's Voluntary Protection Programs or VPP is aimed at promoting worksite-based safety and health. Organizations approved by OSHA to join the VPP is official recognition by the safety agency of an employer's outstanding efforts to ensure a safe workplace and protect its employees.

This article describes the best practices that organizations can follow in order to successfully apply to be part of OSHA's VPP.

The FDA has published a guidance document detailing which studies should be included in the clinical studies section of prescription drug labeling, how individual studies should be described, and what data should be presented. The guidance aims at making the clinical section labeling more useful, helping promote consistency in content and format across various drug product classes and indications.

This article describes the best practices to comply with the recommendations in this guidance.

The FDA-prescribed adverse reactions section makes it easier for healthcare practitioners to identify adverse reactions that are most important for prescribing decisions. This article gives the best practices for complying with the adverse reactions section of labeling for human prescription drug and biological products.

Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms. This article gives the best practices to be followed in order to comply with COREP requirements.

A Suspicious Activity Report or SAR is an essential requirement in order to ensure compliance with the Anti-Money Laundering Law (AML) requirements. It is required by law to be filed with the Financial Crimes Enforcement Network or FinCEN, part of the US treasury department.

Read this article to find out what makes an effective SAR and best practices for writing one.
 

Usually Quality Assurance (QA) is looked upon as bearers of bad news. Then it is forced react with the CAPA (Corrective and Preventive Action) system which is always reactive. Instead, QA can be the bearers of good news by reporting which adverse events were proactively prevented by eliminating their root causes. This article, by renowned medical devices expert Dev Raheja, details the ways this can be achieved.

The FDA requires medical device manufacturers to submit reports in case of device malfunctioning. But when and how are these reports to be submitted? Which medical device malfunctions require reporting to the FDA?

This article describes the best practices that medical device manufacturers can follow in order to comply with medical device reporting to the FDA.

The Solvency II Directive lays down the amount of capital that insurance companies in EU must hold in their reserves so that the risk of insolvency is reduced. The legislation aims to unify the EU insurance market into a single entity and enhance consumer protection. Solvency II was approved by the European Parliament on 22nd April, 2009 and is scheduled to come into effect from 1 January, 2013.

This article describes the best practices to be followed in order to comply with Solvency II's quantitative requirements.

The Food and Drug Administration (FDA) has issued guidelines for adverse event reporting because adverse event reports were found to be inhibiting, rather than enhancing, the ability of IRBs to protect the human subjects.

This article describes the best practices to be followed in order to comply with the FDA's new guidelines on adverse event reporting to IRBs.

The FDA has issued guidance on how to submit 510(k)s for changes to existing devices. This guidance details the types of significant changes that necessitate the need for submitting a 510(k).

This article describes the best practices that medical device manufacturers can follow in order to comply with this guidance.

The U.S. Securities and Exchange Commission (SEC) has approved the consolidated Financial Industry Regulatory Authority Inc (FINRA) rules governing know-your-customer and suitability obligations. The effective date has been set to July 9, 2012. FINRA is the successor to the National Association of Securities Dealers, Inc. (NASD).

This article describes the best practices to comply with FINRA's proposed Know-Your-Customer (KYC) rule.

According to the Internet Crime Complaint Center (IC3) (partnership between the Federal Bureau of Investigation and the National White Collar Crime Center), the most common victim complaints in 2010 in USA were non-delivery of payment/merchandise, scams impersonating the FBI and identity theft.

The Federal Deposit Insurance Corporation has issued guidance on safeguarding customers against E-mail and Internet-Related Fraudulent Schemes. This article describes the best practices that can be followed in order to comply with the FDIC guidance.

The proposed Suitability Rule 2111 of the Financial Industry Regulatory Authority (FINRA) is modeled after the former NASD Rule 2310 (suitability) and requires that a (brokerage) firm "have a reasonable basis to believe that a recommended transaction or investment strategy involving securities is suitable for a particular customer. This belief should be based on the information about the customer's investment profile obtained through reasonable diligence."

This article describes the best practices to comply with FINRA's Suitability Rule 2111.

The Fair and Accurate Credit Transactions (FACT) Act was signed into law by President George Bush in December 2003. This Act incorporates and extends the Fair Credit Reporting Act (FCRA). The enactment of the FACT Act was necessitated by the fact that FCRA’s pre-emption provisions were due to expire in December 2003.

This article describes how FACT improves upon the FCRA.

ISO 14971(Application of Risk Management to Medical Devices) recommends using Preliminary Hazard Analysis (PHA) as an important tool for risk control. PHA is an analysis at macro level.

In this article, medical device expert Dev Raheja describes the best practices to be followed when conducting Preliminary Hazard Analysis when manufacturing devices.

In 2003, the U.S. Securities & Exchange Commission (SEC) adopted audit committee requirements which prohibit the listing of any security of an issuer that is not in compliance with the Sarbanes-Oxley Act (2002).

This article describes the best practices that Audit Committees can follow in order to ensure SEC compliance.

The whole point of IFRS is to produce clear, reliable, relevant, and comparable financial statements that lenders and investors can depend on to make informed decisions. IFRS measures fixed assets in terms of their present and future contributions to the company.

Mike Morley, a Certified Public Accountant, explains the IFRS criteria for valuing fixed assets.

Agency Workers Regulations 2010 are a statutory instrument. The regulations are part of the UK labor law. They aim to combat discrimination against people who work for employment agencies. Towards this end they lay down that agency workers should be no less favorably treated in pay and working time than their full-time counterparts, who do the same work. The regulations came into force on 1 October 2011.

This article gives a brief overview and summary of requirements of these regulations.

The FCPA requires companies whose securities are listed in the United States to meet certain accounting provisions. Global multinationals and financial institutions are at the greatest risk of violating FCPA provisions. The US administration maintains that strict FCPA enforcement is consistent with the goals of promoting transparency, democracy, sustainable development, and good governance.

This article details the best practices that financial institutions can follow in order to achieve FCPA compliance.