Pharmaceutical
CaliberLIMS®, designed for information management in Pharmaceutical Laboratory Operations, will prove to be a versatile tool to improve the lab efficiency, and to promote fast marketability of products, ensuring compliance with the most stringent regulatory norms. Built with cutting edge technology and comprehensive functionality, CaliberLIMS® is sure to help pharmaceutical companies run their laboratories, with a securely automated information flow, whether within the plant or across the global enterprise.
The following are the features of CaliberLIMS® that effectively and efficiently address the specific needs of laboratories in the Pharmaceutical industry
Flexible Sample Workflow that features:
- Pre-registered Master Data items ranging from Products to Print Formats
- Simple but Comprehensive Sample Login
- Sequential Sample Numbering with Configurable Unique Sample ID format
- Configurable and Print Controlled Work Sheets
- Easy to Register and Versatile pre-defined Test Types: 6 test types to suite FDA requirements
- Mandatory Validation of the Result Calculation formulae before Approval (Risk mitigation strategy)
- Configurable, Version Controlled and Print Controlled COA Templates
- Configured COA with traceability (a Caliber Specialty)
- Compiled COA with traceability (a Caliber Specialty)
- Version Controlled Critical Reports.
- Online OOT Alert
- Configurable OOS Workflow with Check Lists and Re-test Options
Administration and Security:
- Strict Compliance to FDA’s 21 CFR Part 11on ER and ES
- Organization wide Security Profile
- Role Based Access Rights and Privileges
- Secure User Login and Access Control
- Secure Password Management
- Comprehensive Audit Trails and Reports
- Complete traceability of Events and Action Ownership
- Certified SAP integration with latest certifications
- Standard configurable Home Page Analytics (a Caliber Specialty)
- Full functionality Stability Studies as per ICH guidelines
- Analyst Qualification by benchmarking & standards testing
- Working Standards: Create, Certify, Store & Use functionality
- Microbial Sub-culturing Management
