Dedicated GxP solution to assure data integrity and compliance with speed and efficiency.
BatchLine Electronic Batch Record system supports compliance with US FDA, EU, and PIC/s based Good Manufacturing Practices (GMP). The System enforces the workflow and allows easy review and approval of the batch record. The system functionality includes creation and management of Batch Specifications (our term for Master Batch Records), Master Data, and the Batches themselves, plus a touch screen interface for batch execution and functions for easy review and approval of the record.
BatchLine Electronic Batch Record system supports compliance with US FDA, EU, and PIC/s based Good Manufacturing Practices (GMP). The System enforces the workflow and allows easy review and approval of the batch record. The system functionality includes creation and management of Batch Specifications (our term for Master Batch Records), Master Data, and the Batches themselves, plus a touch screen interface for batch execution and functions for easy review and approval of the record.
GxP Compliance Features
Access control Built-in System access security mechanisms that perform user ID and password authentication at login based on roles and rights.
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Audit trails and Change Control Provides a full audit trail of all system changes in an easy to read format, easily accessible in context menus throughout the system. These contain all information reuired for GMP use and review with time stamps, user ID, old and new value and comments or reasons.
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Business Continuity BatchLine runs in the class leading Microsoft Azure or AWS Cloud environments, as a Software as a Service (SaaS). Backups are constantly running and automated system failover is standard across 2 geographic locations. It is deployed following best security practices and standards for high data security and reliability.
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Predefined workflow and Data Completion Enforces the defined process as a predefined workflow. The system guides the operators and collects all the data at the point of operation to ensure things happen at the right time in the right order. All data has to be complete before the operator can move on. Data includes meta data and all data elements are reviewed against ALCOA+ for data integrity assurance.
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Review by Exception Built-in plausibility checks for data entry. System performs first check of inputs against approved specification and will alert the user of any out of spec or range by creating exceptions. All data integrity or relevant GxP violations are automatically added for review.
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Annex 11 & 21CFR11 qualified software BatchLine is fully compliant with EU & PIC/S Annex 11 and US FDA Part 11 (Electronic Records and Signatures).
Contact us for a Self-Audit Report |
Maintain Data Integrity BatchLine ensures Batch Record data to be managed under the ALCOA+ principles and the typical improvement over paper record controls.
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See our articles on how BatchLine help to meet Regulations based on applying the GAMP Good Practice Guide (GPG) Data Integrity - Manufacturing Records.
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Part 1: helping to meet ALCOA+ requirements |
Part 2: Risk Assessment for Recorded Data |
Part 3: Managing Master Data |
Take the next step
Start building your Batch Spec on BatchLine today.
