Noverant’s roots were focused originally on FDA-regulated industries that are governed by 21 CFR Part 11 for electronic signature and record keeping.
Upon successful completion of any online training or instructor-led course courses, users receive a 21 CFR 11 Compliant Certificate that they can view or print out at their convenience. Users may also view or print Noverant-certified transcripts and certificates at any time; however, they do not have access to manipulate any of their electronic training records. Management also has access to user records and transcripts and can make auditable changes to records in the event of routine transactions such as force-completing prior training or modifying assignment due dates.
Third Party Access By Regulatory Agencies
With your authorization, Noverant allows access by regulatory agencies and other third parties, and so your job and theirs is made much easier. Noverant systems meet compliance standards for agencies such as:
- Food and Drug Administration (FDA)
- Agency for Healthcare Research and Quality (AHRQ)
- Centers for Disease Control and Prevention (CDC)
- Occupational Safety and Health Administration (OSHA)
- HIPAA Security Risk Assessment
- The Joint Commission (TJC)
- National Committee for Quality Assurance (NCQA)
- Accreditation Commission for Healthcare (ACHC)
- Statement on Auditing Standards No. 70 (SAS-70 Type II)
- Federal Aviation Administration (FAA)
- Transportation Security Administration (TSA)
- International Civil Aviation Organization (ICAO)
- and other agencies
You’re Not Governed By 21 CFR 11?
While 21CFR11 is a very rigorous standard introduced by the FDA, 100% of all state and Federal agencies have accepted 21CFR11 as an approved standard for electronic signature and recordkeeping. From HIPAA-protected information to TSA No-Fly List training, Noverant’s solution provides a secure infrastructure that has been accepted by 100% of our client regulators.
