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Fully validated, 21 CFR compliant in-house developed and web based application.

Salient features

  • Fully validated to meet 21 CFR Part 11 compliance
  • A web based system to manage application modules which are used in bioanalytical lab.
  • CLIMS is compliant with operational & functional requirements of Cliantha Research and regulatory requirements i.e. system access, electronic record storage, review, integrity, security, reliability and audit trails in closed system environment.
  • Initially, CLIMS consist of Admin Module and Doc-Review Module, but not limited to this. Many more modules are on the way and under development to fulfill day to day requirement of bioanalytical lab.

Admin Module

  • Admin Module provides common user management to all modules which will be developed and attached with CLIMS.
  • All modules will be internally linked with the Admin module to manage module wise access of each individual user with their respective functional role.
  • User management is becomes easier with hierarchical role management.

Doc-Review

  • Provides secure and electronic platform for storing printouts in PDF format generated through CDS and other supporting activities in lab.
  • Provides electronic data reviewing to user within lab as well as other department like QA/QC too.
  • Reduces paper from lab and provides digital platform.
  • Assigning unique document ID to each uploaded document.
  • Real time tracking of data within the departments.
  • Each action is audit trailed and validations provide integrity to data.
  • Dynamic reports and dashboard makes life easier for managing and planning of routine work.