Why Assist 4.0 for 21 CFR Part 11?

Industry 4.0 is the information-intensive transformation of manufacturing and other industries in a connected environment of data, people, processes, services, systems and IoT-enabled industrial assets with the generation, leverage and utilization of actionable information as a way and means to realize smart industry and ecosystems of industrial innovation and collaboration.

ASSIST 4.0 is the Atharvana Smart Software for Industrial Solutions and Technology is part of the Industry 4.0 revolution to enable convergence of IT and OT.

The 21 CFR Part 11 regulations from the Food and Drug Administration (FDA) sets forth the criteria under which the agency considers electronic records and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. To provide the security required for compliance with the 21 CFR Part 11 rule, the Assist 4.0 software has in place security functions which provide: Access controls and authority checks via the use of user identification codes and passwords, electronic record security via the use of protected directories & Time and date stamped audit trails.

  • Connected to the Production Systems
  • Electronic Signature Binding
  • Audit Trail
  • Controlled/Secure Access
  • Enhanced Password Security
  • FDA Regulatory Compliance Validation
  • FDA Regulatory Compliance Audit Trail
  • FDA Regulatory Compliance Security & Electronic Signatures