EBR

Dot Compliance's Electronic Batch Record (EBR) solution is designed to help life sciences organizations gain full visibility into their manufacturing processes, eliminate paper-based workflows, and ensure compliance with global regulatory standards. By digitizing and automating batch record management, the platform enables production, quality, and supply chain teams to monitor, manage, track, document, and report on quality processes with greater accuracy and efficiency.

Trusted by leading life sciences professionals worldwide, Dot Compliance empowers organizations to harmonize manufacturing operations, reduce human error, and maintain continuous compliance — all within a ready-to-deploy, scalable platform built on Salesforce.

Key Benefits of Electronic Batch Records

• System Integration: Electronic batch records seamlessly connect with eQMS, LIMS, and ERP systems to create a unified digital environment, eliminating data silos and improving coordination across production, quality, and supply chain operations.
• Effortless Scalability: The platform adapts easily to growing production volumes and evolving process complexity, allowing organizations to add new products, sites, or workflows without disrupting existing operations.
• Reduced Risk of Errors: Automated data entry and built-in validation rules verify inputs at every step, maintaining data integrity and regulatory compliance, and enabling teams to accelerate batch release with confidence.

Features and Capabilities

• eQMS and MES Integration: Seamlessly integrates the electronic Quality Management System with Manufacturing Execution Systems to deliver full visibility into the EBR and simplify management of manufacturing processes.
• Regulatory Compliance: Ensures compliance with regulatory agencies including the FDA and EMA, as well as cGMP standards and other global requirements.
• Document Management: Allows users to organize, manage, and track documents, images, and other digital content necessary for conducting clinical trials and manufacturing operations.
• Process Automation: Reduces the manual burden associated with paper-based processes by linking quality documents throughout the manufacturing workflow, including work instructions, SOPs, electronic forms, batch records, and test results.

Broader QMS Module Suite

• Document Management
• Change Management
• Quality Event Management
• Audit Management
• Training Management
• CAPA Management
• Complaint Management
• Risk Management
• Supplier Quality Management
• Equipment Management
• Electronic Batch Management

Compliance Standards Supported

• Quality & Compliance: ISO/IEC 42001, ISO 9001, ISO/IEC 27001, GAMP 5, ISO/IEC 27017, 21 CFR Part 11, EU Annex 11
• Medical Device: 21 CFR Part 820, ISO 13485, ISO 14971
• Pharma & Biotech: 21 CFR Part 210, 21 CFR Part 211, cGMP, cGDP, GCP

Deployment and Implementation

• Dot Compliance runs on the Salesforce platform — no separate Salesforce license is required, as everything needed is included.
• Pre-configured, ready-to-deploy solutions enable rapid implementation without extensive customization.
• The modular platform allows organizations to start with the capabilities they need today and expand over time as they grow.
• All solutions come with full validation packages meeting global regulatory standards, including 21 CFR Part 11 and EU Annex 11.
• Native Salesforce integration provides seamless connectivity with ERP systems and other critical tools.

Dot Compliance's EBR solution is purpose-built for life sciences companies seeking to replace paper-based batch records with a compliant, scalable, and fully integrated digital system. With global compliance baked in and a comprehensive suite of quality management modules, organizations can maintain inspection readiness and manage quality with confidence at every stage of manufacturing.