Digital B-Line Suite - Compliance with Global Regularities Body
GMP Consultancy & Audit Readiness (WHO-GMP || USFDA || EU GMP || MHRA || TGA || PIC/S)
Before you need the software, you need the strategy. Our pharma compliance experts conduct gap analysis, prepare your facility for regulatory inspections, and guide you through WHO, FDA, and EU GMP certification — from documentation to shopfloor practices.
– GMP Gap Analysis & Facility Assessment
– WHO-GMP, FDA Pre-Inspection Preparation
– SOP Writing, Review & Approval Framework
– Quality Manual & Site Master File (SMF) Creation
– CAPA Implementation & Deviation Management
– Mock Audit & Inspector-Ready Checklist
– Post-Inspection Remediation Support
– EU GMP Annex 11 — Computerized Systems Guidance
Computer System Validation (CSV)
Ensure your computerized systems are fully compliant with global regulatory requirements. Our validation experts deliver end-to-end CSV services that minimize business risk, stabilize manufacturing processes, and keep your systems audit-ready at all times.
– Validation Master Plan (VMP) Development
– Risk-Based Approach — GAMP 5 Category Determination
– User Requirements Specification (URS)
– IQ, OQ, PQ Protocols & Execution
– Electronic Records & Signatures Validation
– Regulatory Checklist — FDA, EU, PIC/S
– SOP for Digital Record Storage (GAMP 5)
Bline Pharma Suite 4.0 — Pharma ERP Platform (ALCOA+ || 21 CFR Part 11 || EU Annex 11 || GMP )
A future-ready, unified pharmaceutical operations platform. Manage your entire manufacturing and compliance workflow in a single, audit-ready system eliminating paper, silos, and manual errors across every department.
– eBatch MES — 1-Click BMR & BPR Report Generation
– QMS — CAPA, Deviation, Change Control
– LIMS — Lab Execution & Sample Management
– eLogbook & eCalibration — Equipment Lifecycle
– WMS — Warehouse, GRN, Expiry Management
– HRMS — Employees, Training Records & Certification
– Role-Based Access Control (RBAC) & Audit Trail
Integrated Factory Automation Suite
Break the silos between your machines and your management. We build Smart Factories by converging Operational Technology (OT) with Information Technology (IT) — from sensor to CEO dashboard, in real time.
– PLC & SCADA Integration with Bline Automation Suite
– Real-time OEE Dashboard — Availability, Performance, Quality
– IoT Sensor Integration — Temperature, Humidity, Air Quality
– Automated Control Loops for Critical Parameters
– HPLC, GC-MS, Spectrophotometer Connectivity
– OT Cybersecurity — Defense-in-Depth Strategy
– Digital Twin Integration for Process Optimization
Agile Implementation & User Training (Agile || 2× Speed || On-site 24×7)
We don’t just hand over software, we hold your hand until you’re live. Our agile delivery model runs at 2× the speed of traditional implementations, with on-site training for every user level, from shopfloor operators to QA heads.
– Master Data Upload & Configuration
– Department-wise User Training & Demo Practice
– Go-Live Support, Dedicated On-site Resource
– Complete Handover with Documentation
– Kiosk & Touch Device Setup & Integration
– Custom Workflow Configuration per Plant Needs
24×7 Premium Support Program (24×7 || Unlimited WhatsApp & Call || Screen Share)
In a regulated pharma environment, downtime is not an option. Our support team is available round-the-clock, across multiple channels with guaranteed response times and unlimited incident coverage. You call, we answer.
– Unlimited Incidents — No Support Ticket Caps
– Phone, Email, WhatsApp & Screen Sharing
– High Priority Response: 4–8 Hours
– Urgent Resolution: Within 12 Hours
– Custom Development & Change Control Management
– Quarterly System Health Checks
– Regulatory Update Patches Included
Ready to be Always Audit-Ready?
