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