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.…

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FDA 21 CFR Part 11 Solution

Compliance with FDA regulations on electronic records and electronic signatures (21 CFR Part 11) Title 21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic records and electronic signatures. It requires most companies that deal with the FDA, such as pharmaceutical companies, to implement controls that ensure the integrity of their documents. Assist 4.0 approach to compliance To provide the security required for compliance with the 21 CFR Part 11 rule, the software has in place security functions which provide: Access controls and authority checks via the use of user identification codes and passwords. Electronic record…

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Main Benefits & Challenge

How Does Assist FDA 21 CFR Part 11 Software Provide You the Structure to Go Beyond Compliance?

Advantages

  • Reduced audit time and findings
  • Improves product quality and safety
  • Decreases risk
  • Ensures FDA compliance

Modules and Functionality

  • User administration
  • Alarm Management
  • Batch control
  • Audit trail
  • Analysis
  • Reports

GAMP 5 Process for development

  • Requirements gathering
  • Risk assessments
  • Creation of functional and other specifications
  • System configuration
  • Testing and other verification
  • Documentation should be assessed for suitability, accuracy and completeness