Regulatory Compliance Services

We specialize in regulatory compliance and bring strong expertise to address requirements of the GLB Act, HIPAA and 21 CFR 11. Our staff have been involved in regulatory issues since the early 1990s and were among the first to develop a methodology to address HIPAA legislation that is currently in use by numerous consulting organizations. We have significant expertise with the Gramm-Leach-Bliley (GLB) Act provisions as well as areas of Privacy Policy. We perform FDA validation services for Digital Signatures, Systems Security, Access Control and Accountability, Software and Data Integrity for 21 CFR part 11 compliance. Through a partner company, we provide validation services for Process Control Systems, SCADA and Automated Manufacturing Systems, bringing 10 years combined experience to provide you assurance.

We bring extensive expertise, proven protocol development and validation methodologies, and third-party independence to your compliance preparation and validation efforts. We are completely vendor-independent and adhere to the highest code of ethics in our work.

Regulatory Services data sheet (69k, pdf)

Service Assurance Methodology™ data sheet (96K, pdf)

We would be glad to meet with you to discuss your specific needs and identify areas where our services can most effectively assist you in meeting your goals.

Choose the Contact button on the menu above to request more information or an on-site visit to further discuss your needs.

 

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