AUDIT READY - IT SOLUTIONS
OUR SYSTEM STRIVES TO MEET THE LATEST REGULATORY AND SECURITY GUIDELINES – 21 CFR Part 11, Good Laboratory Practices (GLP), GMP (Good Manufacturing Practice)
BLINE PHARMA SUITE (BASE – Solution Can fit any Process and Operations) –
DIGITAL B-LINE SUITE = BASE PLATFORM + AI with IoT and Kiosk
The Digital B-Line Suite is an innovative, web-based application meticulously designed to address the unique challenges of the pharmaceutical and related industries.
The suite leverages cutting-edge machine learning algorithms to analyze datasets, predict outcomes, and optimize critical processes. Combined with NLP capabilities.
The suite ensures precise monitoring and real-time control of industrial operations. This automation minimizes manual intervention, enhances accuracy, and provides actionable insights for continuous improvement.
BLINE QUALITY MANAGEMENT SYSTEM (eQMS) –
Bline QMS is effortlessly maintain data accuracy and consistency.
Empowering organizations to achieve 100% data integrity while ensuring seamless audit compliance.
* Document Control – SOP, Policies, and Records
* Audit Management
* CAPA (Corrective and Preventive Actions)
* Change Management
* Training Management
* Risk Management
* Complaint Handling
BLINE LEMS/LIMS – Lab Execution Management System –
Compliance with regulatory standards- GMP, USFDA 21 CFR Part 11.
Tracks laboratory supplies, reagents, and consumables to prevent shortages or overstocking. Optimizes resource allocation, reducing costs and improving efficiency.
* Sample Management
* Data Integrity & Compliance
* Test Management
* Integrates quality control checks
* Advanced Analytics and Reporting:
* Instrument Integration
BMES – Batch Manufacturing Execution System-
Batch Manufacturing Records & Batch Packing Records Management
Optimize production workflows, and maintain full regulatory adherence throughout the GMP process.
* Master Formula Control
* Batch Planner
* Line Clearance
* Detail Process Automation
* 1 bmr/bpcr Report Generate
eLOGBOOK – Electronic Logbook Management –
Compliance with regulatory standards – GMP, USFDA 21 CFR Part 11.
BLINE ELMS efficiently manages real-time equipment usage logs, maintenance records, and batch records with options for semi-automated and fully automated processes, organized by department.
* Centralized database for easy access and retrieval.
* Secure storage to maintain data integrity.
* Meet 21 CFR Part 11, EU Annex 11, and other GMP regulations.
* Electronic signatures and audit trails
* Tracks overdue entries or deviations.
* Alerts for pending reviews, validations, and updates.
* log history with timestamps
Pharma WMS – Warehouse Management System-
Barcode Management, batch and lot tracking, expiry date monitoring
* Real-time tracking of raw materials, intermediates, and finished goods.
* Batch and lot tracking with complete traceability.
* Automated stock replenishment based on predefined rules
* Audit trails for all inventory movements.
* Record retention and electronic signature capabilities for regulatory audits.
* Expiry date tracking and Shelf-Life Management
* Alerts for condition breaches
* Support for multiple warehouses and locations.
* Automated labels.
Business Private Cloud System –
Managing sensitive data or running mission-critical applications, our dedicated cloud environment gives you full control, custom configuration, and enterprise-grade security without compromise. – Secure, Scalable, and flexibile
* Exclusive Resources: Enjoy dedicated servers and isolated environments—no sharing, no slowdowns.
* Military-Grade Security: Your data stays protected with end-to-end encryption, firewalls, and compliance-ready systems.
* Scalable Infrastructure: Grow effortlessly as your business expands, add storage, memory, or compute power instantly.
* Tailored for You: Custom-built to fit your specific workloads, compliance needs, and performance goals.
Custom Business and Audit-Ready Application Development-
We specialize in creating fully customized applications that align perfectly with your operational workflows with built on a ready-to-use enterprise base platform. – while meeting the highest standards of security, scalability, and audit compliance.
* Reusable base architecture to reduce development time and cost while maintaining enterprise-level quality.
* Every application is built with detailed logging meet internal and external audit requirements.
* Designed for high availability, scalability, and reliability — supporting both growing startups and large-scale enterprises.
* Real-Time Data & Insights
Success is built on trust. – Trust starts with transparency – ( CHOOSE YOUR BEST CLOUD SERVER )
GCP & BCP (GOOGLE CLOUD PLATFORM / BLINE OWN CLOUD PLATEFORM )