softBMR

softBMR – Electronic Batch Manufacturing Records (EBMR) is a module from Pharmasoft designed for pharmaceutical and biotech manufacturing operations. It converts traditional paper-based Batch Manufacturing Records into electronic, guided workflows, directing operators through each manufacturing step in sequence and ensuring all activities follow validated procedures. The system is intended for production teams and quality assurance functions that need to reduce documentation errors, accelerate batch release, and maintain GMP and regulatory compliance.

The module embeds process controls, real-time validations, and automated calculations directly into the batch execution workflow. Quality teams benefit from a Review by Exception approach, where deviations and abnormal results are flagged immediately, enabling faster batch review and release decisions without manually scanning entire records.

Intelligent Digital Batch Execution

• Guided manufacturing workflows aligned to GMP-validated steps, requiring operator confirmation and sign-off at each stage before proceeding to prevent skipped or out-of-sequence activities
• Automated calculations covering temperature range validations, weight calculations, yield computations, material quantity verifications, time checks, and concentration calculations
• Real-time operator guidance with exception prompts when process parameters fall outside defined limits
• Integrated electronic signatures at all manufacturing steps and approval stages, capturing user ID, timestamp, and meaning of signature in compliance with 21 CFR Part 11

Automated Compliance and Review Efficiency

• Review by Exception functionality that highlights deviations and abnormal results instantly for faster batch review and release cycles
• Time-stamped audit trails recorded for every data entry and action taken within the system
• Rule-based checks applied during execution to prevent deviations before they occur
• Centralized access to batch records for QA review across product lines
• Automates BMR and BPR review and approval processes as a fully paperless solution

Enhanced Accuracy and Right-First-Time Manufacturing

• Auto-verification of critical process parameters during batch execution
• Elimination of paper-based documentation and transcription errors through guided data capture
• Integrated equipment logbooks and usage tracking within the batch record
• Real-time visibility into batch progress and discrepancies as they arise

Key Benefits

• Eliminates manual documentation errors and paper records
• Supports faster batch review and release, reducing inventory holding time
• Accelerates product availability through digital batch release workflows
• Strengthens data integrity and enhances traceability across batch records
• Ensures full compliance with GMP and regulatory requirements
• Supports Right First Time manufacturing by reducing process variations and ensuring consistent batch execution
• Reduces operational workload by digitizing compilation, review, and QA release activities
• Eliminates paper-based record storage and handling

Reported Performance Metrics

• 50–70% reduction in batch record review time
• $20,000–$80,000 in annual savings from eliminating paper BMR storage
• Batch release cycle accelerated by 2–5 days
• 30–50% reduction in documentation-related deviations

softBMR is browser-based and accessible from any LAN-connected computer or approved device on the production floor, supporting flexible deployment without specialized hardware. It is part of Pharmasoft's broader suite of operations, quality, and laboratory modules designed for regulated pharmaceutical and biotech environments, and is positioned within a platform that also covers QMS, LIMS, and equipment management functions aligned to Pharma 4.0 requirements.