Pharmaceutical LIMS
CaliberLIMS® is a pharmaceutical laboratory solution designed for information management in Pharmaceutical Laboratory Operations. It is a versatile tool to improve the lab efficiency, and to promote fast marketability of products, ensuring compliance with the most stringent regulatory norms. CaliberLIMS® is 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 an efficient and effective pharmaceutical laboratory solution like CaliberLIMS®
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
