Regulatory Compliance

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Technology related compliance requirements are a fact of life for many businesses today. Some are faced with the pressures and required changes set forth by Sarbanes-Oxley. Companies in healthcare and life sciences are racing to ensure compliance with HIPAA and CFR 21 Part 11 standards. While many see these compliance standards simply as necessary evils, there is opportunity to take these mandates and create value from the change that they bring. Evolve Partners understands the challenges and opportunities related to compliance.

Sarbanes-Oxley
Named after Senator Paul Sarbanes and Representative Michael Oxley, the Sarbanes-Oxley Act “SARBOX” (also known as the Public Company Accounting Reform and Investor Protection Act of 2002) became law in July 2002. Many companies subject to this legislation know it by the new methods and controls imposed in accounting standards. However, SARBOX also provides for specific restrictions, controls and methods for the handling of data related to financial records as well as security to critical information technology systems. It provides for guidelines that are at best vague and quite arduous for a company to comply with. There are no step-by-step guidelines provided by the Act for compliance. Moreover, it is not a one-time event; companies must maintain their compliance year after year.

HIPAA
The Health Insurance Portability and Accountability Act of 1996 “HIPAA” in part is designed to improve the efficiency of healthcare delivery by requiring providers and health plans to implement a standardized electronic data interchange solution. This solution would allow for greater patient access to medical records and provide for more control over how that information is used. Most importantly, the Act sets forth standards on safeguarding patient information in technology systems used in the healthcare system.

CFR 21 Part 11
The US Food and Drug Administration “FDA” has set forth guidelines for the application, retention and use of electronic signatures, electronic document filings and storage related to life sciences companies. The CFR guideline includes many other requirements placed on life sciences companies. Our solution helps life sciences firms with the requirements of cataloging and retention of key electronic documents.

Evolve Partners along with our key audit and preparedness partners have years of experience in readying companies for these and other regulatory compliance requirements now in effect or on the horizon. Beyond the requirements themselves, are many operating efficiencies, mitigation of risk and other preparedness benefits by starting early with compliance initiatives. Whether you are faced with compliance needs today or anticipate them in the near future, the key is planning. Let us help you with making sense of these requirements and prepare your IT infrastructure to adapt for what is to come.