Pharmaceutical Manufacturing

CannyECM for e-BMR

Electronic Batch Manufacturing Record

Digitize, Control, and Comply with Confidence

In pharmaceutical manufacturing, batch records are the backbone of product quality, regulatory compliance, and patient safety. CannyECM e-BMR transforms traditional paper-based Batch Manufacturing Records into a fully digital, compliant, and audit-ready system—streamlining operations while meeting global regulatory standards.

e-BMR Dashboard Interface

Challenges with Paper-Based BMR

Traditional paper-based batch records create significant operational and compliance challenges that impact product quality and time-to-market.

Manual data entry errors and missing records

Time-consuming batch review and release cycles

Difficulty in tracking deviations and corrections

Risk of non-compliance with regulatory audits

High storage and retrieval costs for physical records

CannyECM e-BMR Solution

CannyECM provides a secure and centralized Electronic Batch Manufacturing Record (e-BMR) platform that covers the entire batch lifecycle—from material issuance to final batch release.

Key capabilities include:

  • Digital batch record creation and execution
  • Real-time data capture from shop floor operations
  • Controlled workflows for review, approval, and release
  • Secure electronic signatures with full audit trails
  • Seamless integration with existing ERP, MES, and QMS systems

Key Features

Comprehensive capabilities designed for pharmaceutical manufacturing excellence and regulatory compliance.

End-to-End Batch Lifecycle Management

Digitize batch instructions, process parameters, in-process checks, and yield calculations in a single unified system.

Controlled Workflows

Automated workflows ensure batch records move through Production, QA, and QA Release with defined roles and approvals.

Audit Trail & Traceability

Every data entry, modification, and approval is time-stamped, user-identified, and fully traceable for complete accountability.

Electronic Signatures

Supports compliant electronic signatures for operators, supervisors, QA, and all authorized personnel.

Deviation & Exception Handling

Capture deviations, comments, and corrective actions directly within the batch record for seamless documentation.

Document Version Control

Ensure only approved and current batch records are used for manufacturing with strict version management.

Regulatory Compliance

CannyECM e-BMR is designed to support compliance with global pharmaceutical regulatory standards.

21 CFR Part 11

FDA Electronic Records

WHO GMP

World Health Organization

EU GMP Annex 11

European Union Standards

Schedule M

India GMP Requirements

ALCOA+

Data Integrity Principles

Benefits

Transform your batch manufacturing operations with measurable improvements in efficiency, compliance, and cost savings.

Faster batch review and release

Reduced human errors and rework

Improved regulatory audit readiness

Enhanced data integrity and security

Lower operational and documentation costs

Ideal For

CannyECM e-BMR is designed for pharmaceutical and life sciences organizations requiring compliant batch record management.

Pharmaceutical Manufacturing Units

API & Formulation Plants

Contract Manufacturing Organizations (CMOs)

Clinical Trial Manufacturing Facilities