System Overview

Code PV is Cliantha’s proprietary, 21 CFR Part 11, web-enabled secure cloud based Pharmacovigilance software and case safety management solution.

All functionalities are integrated in simple user friendly intuitive manner, saving time, money and resources. CodePV is workflow and process driven system. A customized workflow is integrated with safety functionality

Code PV follows the regulatory compliance standards and norms. Supports regulatory reports such as CIOMS and MedWatch. PSUR and DSUR as well and MedDRA / WHODD coding.

Code PV support custom workflow, all the process can be customized as per request.

Key Features :

  • Track submission deadlines.
  • Multi-tenant functionality for the creation of separate data environments.
  • Compliant with relevant drug safety regulations.
  • Cost effective PV software solution.
  • Quick to install with no need for customization.
  • Flexible and customized workflow
  • Validated
  • Customizable and user friendly
  • Compliances
  • Business intelligence and signal detection.
  • Available also as SaaS module
  • Standard Reports
  • Extensive data validation
  • Duplicate check function
  • FDA 21 CFR Part 11 compliance.
  • Notes may be added to any field.
  • Full Audit Trails
  • Form Generation
  • Handle user time zone in global implementation.
  • Create Common Regulatory Reports such as CIOMS, MedWatch, PSUR and DSUR
  • Instant Validation