The Digital B-Line Suite is a cutting-edge Web-Based Advanced Application specifically designed to meet the unique needs of the pharmaceutical and Nutraceuticals industries.
It combines state-of-the-art technology with robust functionality to deliver a fully integrated, multi-tier architecture solution that is highly flexible, secure, and customizable without requiring any process changes or compromises.
Digital B-Line Suite features :
A strong focus on compliance, meeting stringent regulations such as cGMP (current Good Manufacturing Practice), Schedule M, and other critical regulatory requirements.
Complete top-to-bottom and bottom-to-top traceability, ensuring transparency and accuracy in all aspects of your operations.
An inbuilt security server with layered protection, providing an additional safeguard for your enterprise data.
Comprehensive Disaster Recovery & Backup Management, ensuring business continuity and data safety at all times.
An in-built report engine that delivers powerful insights through Data Science & Analytics tools, helping businesses make informed decisions.
Increased productivity and efficiency through process automation and better resource management.
Enhanced compliance with regulatory standards, thanks to integrated features for batch management, calibration, and document control.
Improved visibility and real-time insights through analytics that help track performance across all departments.
Better collaboration between departments, with streamlined workflows connecting QC, production, supply chain, and warehouse operations.
Digital B-Line Suite is Industry 4.0 IoT-ready, offering seamless integration with industrial devices and enterprise mobility tools. Its advanced framework supports real-time operations across your business ecosystem, providing unmatched scalability and reliability.
1. User Control Management: To manage user accounts, permissions, and security protocols, ensuring that access to the system is restricted to authorized personnel only.
Key Features:
– Role-based access control (RBAC) for different departments like QC, production, and regulatory.
– IP restrictions, login history tracking, and multi-factor authentication (MFA).
– Advanced audit trails for compliance with regulatory standards (FDA, GMP).
– Field-level security and robust user governance.
2. Warehouse Control Management: To oversee and optimize warehouse operations, including inventory management, stock movements, and material handling in compliance with Good Manufacturing Practices (GMP).
Key Features:
– Real-time inventory tracking (raw materials, WIP, finished goods).
– Integration with barcode/RFID systems for stock monitoring.
– Expiry date tracking, batch and lot traceability.
– Automated stock replenishment and warehouse optimization algorithms.
3. Production Management with eBMR (Electronic Batch Manufacturing Record) and eBPCR (Electronic Batch Production Control Record): These systems ensure full digitalization and automation of production processes while maintaining compliance with regulatory requirements.
Key Features:
– Real-time data capture and monitoring of production batches, batch planning.
– Automated record generation for production steps, ensuring accuracy and traceability.
– Integration with manufacturing execution systems (MES) and quality control systems.
– Electronic signatures, ensuring compliance with 21 CFR Part 11.
4. eDoccell Management System: To manage the creation, approval, distribution, and archiving of documents critical to pharmaceutical operations, such as SOPs, batch records, and compliance documents.
Key Features:
– Workflow-based document management (creation, review, approval).
-Version control and secure storage of all documents.
– Audit trails for document access and modifications.
– Integration with regulatory compliance standards (GMP, 21 CFR Part 11).
5. eQMS Management System – QC/QA: To oversee Quality Control (QC) and Quality Assurance (QA) processes to ensure compliance with Good Manufacturing Practices (GMP).
Key Features:
– QC process automation for sample management, testing, and result recording.
– QA for ensuring that processes are being followed as per SOPs and regulatory guidelines.
– Non-conformance tracking and corrective action/preventive action (CAPA) management.
6. Dignosys: A centralized platform to manage various quality-related processes in the pharmaceutical environment.
Key Features:
- CAPA (Corrective and Preventive Actions): Tracking, implementation, and verification of CAPA initiatives.
- Investigations: Root cause analysis and investigation management for deviations and non-conformances.
- Market Complaints: Capture and address complaints from the market, linking them to CAPA if necessary.--
- SOP (Standard Operating Procedures): Document management and workflow for creating, reviewing, and training on SOPs.
- Training: Employee training management linked to SOPs and regulatory requirements.
- Change Control: Control and document changes in processes, equipment, or documents in a regulated manner.
- STP (Standard Test Procedures): Management of testing protocols for product and material quality.
7. eLog Book: A digital logbook for tracking production activities, machine usage, equipment cleaning, and other operational tasks, ensuring that everything is recorded and traceable.
Key Features:
– Digital capture of all operational data related to machines and processes.
– Automated entries, reducing manual logging errors.
– Integration with IoT devices to capture real-time machine usage data.
– Compliance with audit requirements and regulatory guidelines for data integrity.
8. eCalibration: To manage and schedule calibration of equipment, ensuring that all machinery and instruments are maintained in compliance with regulatory standards.
Key Features:
– Scheduling and notification system for regular calibrations.
– Calibration record management, including certificates and reports.
- Non-compliance alerts if calibration is overdue or failed.
- Integration with QC and production systems for seamless process control.
9. IoT Board: integrate IoT-enabled devices with the bline pharma suite to capture real-time operational data, automate processes, and enhance system efficiency.
Key Features:
– Real-time monitoring of production equipment (temperature, pressure, machine status).
– Automated alerts for deviations or equipment failure.
– Predictive maintenance through analytics of machine data.
– Data integration with production, QC, and calibration systems.
10. Analytics Dashboard: To provide a centralized platform for monitoring key performance indicators (KPIs), operational metrics, and real-time data across all systems.
Key Features:
– Customizable dashboards for different departments (production, quality, warehouse, supply chain).
– Real-time data visualization for decision-making.
– Predictive analytics for process optimization, capacity planning, and demand forecasting.
– Integration with all modules to provide holistic insights into business performance.
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