BatchLine: Electronic Batch Record System
Our sister company, BatchLine is a simple and effective electronic batch record system that saves lots of time and effort producing, reviewing, and approving your batch records. It is specifically designed to provide a new approach to EBR, offering process and management tools powerful enough for larger organisations, but with a scalable architecture and flexible pricing to meet the needs and budgets of practically any sized pharmaceutical manufacturer.
- Designed in compliance with CFR Part 11, Annex 11, PIC/S GMP, EU & US FDA Data Integrity Guidelines
- Provides the main functionality & benefits commonly found in traditional MES/EBR system at around 20% of the cost
- Cloud SaaS, Private Cloud, & On-premise deployment options
- Developed and Validated following GAMP 5 methodology
- Right-First-Time and Review-By-Exception
- Reporting and analytics dashboard for overall factory productivity and compliance
- Product based reporting and analytics including data export tools for APQR
BatchLine Explainer Video
Highly powerful and low cost pharma specific EBR tool that is one of a kind, pre-validated, and ready for you to use right now..
Benefits of an BatchLine Electronic Batch Record System
- reduce cycle time
- automatic generation of final batch report
- review by exception
- only approved batch spec can be used for recording
- huge reduction in operational errors
- automated sequence control of manufacturing process into correct steps
- automatic data completeness check
- reduce compliance and operating costs from operating and manufacturing products in a consistent and compliant manner
- massive reduction in paper costs, printing, processing, and storage
Fully GxP Compliant
- designed specifically to meet requirements for GxP regulated production. US FDA 21 CFR Part 11, EU and PIC/S GMP Annex 11.
- maintain Data Integrity and compliance