Managing a comprehensive risk and compliance program is difficult and very complex. With manual efforts, these programs become impossible. Life Sciences require better best practice models coupled with new automated approaches. Traditional GRC platforms are not viable solutions for automating compliance processes for Life Sciences organizations. These applications require advanced automation solutions tailored to the workflows and compliance content of the industry.
The threat of organizational and supply chain risks dictate that Life Sciences organizations must find a solution that can be deployed quickly, and deliver value promptly.
Avior's BenchMark solution is an on-demand, SaaS-based platform with pre-built assessments and reports, and an integrated workflow. BenchMark ensures that all compliance programs can be quickly automated, which in turn creates worth.
Avior's vast experience with Life Science organizations enabled us to create solutions that automate program management enterprise risk and compliance programs. Avior's solutions allow organizations to more effectively manage a myriad of regulations and guidance.
Vendor Risk Management programs with pre-built libraries of assessments, best practice mappings, dashboards, and reports. All aspects of supply chain risk are covered: quality/status, financial, scalability, and regulatory. Key regulations and models are pre-configured and mapped through Avior's patent pending Dynamic Compliance Matrix.
Product and Organizational Risk programs with proven best practice models. These solutions are structured so your organization can begin in a focused area of need then expand across the entire enterprise. A sample of sections are; medical affairs, marketing-compliance, core product, pharmacovigilance, tampering-counterfeiting-theft, issue-crisis management, and CQA-Audit.
Corporate Integrity Agreements are imposed by the Department of Health and Human Services (DHHS). They were created as part of a settlement resulting from federal health care program investigations arising under a variety of civil statutes. A provider or entity must consent to these obligations in exchange for DHHS's agreement not to exclude the health care provider or entity from participation in Medicare, Medicaid, and any other federal health care programs.
Health Care Portability and Accountability Act (HIPAA) requires a new EDI standard as of January 1, 2012 and new expanded diagnostic codes by October 1, 2013 for all insurance and Medicare transactions. Payers must ensure that every affiliate submitting claims (and other transactions), comply and are compatible to these standards. Failure to comply will result in significant lost revenue.
Centers for Medicare and Medicaid Services (CMS) Security Audits require regulated entities to conduct formal assessments of the security of HIPAA regulated data including affiliates, vendors, and other business associates.