Electronic Batch Records (EBR) - MasterControl Mx

Electronic Batch Records (EBRs) are a digital form of production documentation that replaces traditional, paper-based batch production records in regulated industries.

Key Features and Benefits:

Regulatory Compliance: MasterControl EBRs are designed to meet 21 CFR Part 11 (FDA) requirements and Good Manufacturing Practices (GMP) principles.

Automation and Data Integrity: The system enforces real-time data entry, performs automatic calculations, and validates entries, eliminating human error.

Accelerated Production: Thanks to their digital format, reports can be reviewed and approved much faster, reducing batch review times and allowing for faster product release.

Traceability and Control: EBRs ensure full process traceability – from raw materials to finished product, facilitating audits.

MasterControl Mx, it's a tool that ensures that every production step is properly documented and follows procedures, without the need for paper.