Are you struggling with Manual Batch records?
- Error prone documentation: Involves filling of scores of forms and papers. This is tedious, laborious, monotonous, time-consuming, and above all, highly error-prone.
- Un-controlled Document Templates: Complicates preparation of document templates and version management of generic templates distributed across the enterprise-wide computers
- Manual Issuance: Takes more time to fill the same or similar details on multiple pages. Renders manual paper movements more expensive and slow due to redundant data entries.
- Time consuming Review and Approval process: Delays releasing of the batch material due to time consuming review and approval process for executed batches.
Caliber offers a comprehensive solution for total Electronic Batch Records Management as per GLP
Electronic Batch Records Management System
CaliberBRM Organizes, Controls and Automates the entire Batch Records Management process in a regulated industry like Pharmaceuticals, where Batch Manufacturing takes place and meticulous records need to be maintained. It provides an innovative automation solution right from systematic and structured organization of documents to fully automated on-line product documentation.
Implementing CaliberBRM in your lab results in big savings in otherwise voluminous paperwork, time and effort, and reworks due to human errors.
- Quicker turn-around time for preparing Master Bach Records.
- Access controlled & version controlled structured templates.
- Reusable Header, Footer, Index & Generic Template Repositories.
- Huge reduction in repetitive entries thereby improving batch closure time and risk management.
Ensures Zero errors:
Elimination or drastic reduction in human errors in
- Record keeping
High level of Automation and Integration:
Integration with other applications for easy flow of the entire batch process.
- Process clearance
- Equipment clearance
- Integration with ERP.
Improved efficiency and compliance
- Replacement of huge paper based doc folders with 21 CFR Part 11 complaint electronically signed e-documents.
- Improving efficiency in utilization of resources like people, time, material, equipment etc.
- Continuous Process Improvement
- Compliance with guidelines/regulatory norms on Batch Automation and Electronic Documentation like ISA 88, 95, US FDA 21 CFR part 11 etc.
- Control on Equipment and Material Usage.
- Configurable Document Work flows with authenticated review and approval processes
- User Configurable workflows, Templates, Reports, Dashboards, Labels.
- Online deviations and observations recording reduces batch documentation closure time.
- Online- trends available for completed batches helps in improving batch quality and CAPA management.
Highly Scalable Architecture:
- Seamless integration with SAP/ERP
- Seamless integration with Balances and application of the 4 eye principle.
- Updating stock at various stages of initial dispensing and returns.
- Bi-directional interface with LIMS is unique with CaliberBRM which improves data integrity.
Integration with Mobile devices:
- Task based work assignment helps in using hand held devices with ease.
- Replacing the entire batch record movement with task based batch document through hand held device making the task simple and easy.
- Replacement of manual documentation with electronic documentation through hand held devices thereby saving huge burden of maintaining paper documents.
- Improved compliance due to clear and crisp work inspections and validated data entry.