GxP & Pharma Software Solutions
Turnkey, audit-ready digital platforms engineered specifically for pharmaceutical manufacturing, QC laboratories, and life sciences compliance.
Pre-Validated Software
Complete IQ/OQ/PQ protocols, URS, and validation packages included with every deployment.
21 CFR Part 11 Ready
Built-in dual authentication e-signatures, immutable audit trails, and strict role access controls.
Cloud or On-Premise
Flexible hosting architecture tailored to your IT infrastructure and regulatory data sovereignty.
Digital GxP Systems Suite
Eliminate paper bottlenecks and human error with our modular, compliant software suite designed for Indian and global regulatory audits.
eQMS — Electronic Quality Management System
Enterprise GxP quality management platform designed for pharmaceutical manufacturers. Automates quality processes, eliminates paper silos, and provides real-time oversight for deviations, investigations, and corrective actions.
- Deviation & Incident Management with root-cause analysis tools
- Automated CAPA workflows with effectiveness review tracking
- Change Control with cross-departmental impact assessment
- OOS / OOT laboratory investigation workflows
- Market Complaint handling and pharmacovigilance logging
- Executive quality dashboards and inspection readiness reporting
eDMS — Electronic Document Management System
Compliant electronic document management software for life sciences. Streamlines drafting, reviewing, approving, and distributing SOPs, batch records, validation protocols, and technical specifications.
- Automated SOP lifecycle with multi-level review and approval
- Role-based electronic signatures (dual authentication)
- Dynamic watermarking for controlled viewing and printing
- Automated version numbering and obsolescence control
- Audit-trailed metadata search and secure cloud/on-premise storage
- Seamless integration with LMS for instant training triggers
LMS — GxP Learning & Training Management
Purpose-built learning management system for pharmaceutical plants and QC laboratories. Ensures 100% training compliance before employees execute GxP activities.
- Dynamic training matrices mapped to job roles and departments
- Automated retraining triggers when SOPs are revised in eDMS
- Online assessments, timed quizzes, and automated scoring
- Digital training certificates and supervisor sign-offs
- Non-conformance alerts for overdue training requirements
- Single-click auditor-ready training history logs
Audit Trail Review & Analytics Software
Automated solution for extracting, analyzing, and reviewing audit trails from HPLC, GC, UV, and laboratory data systems to guarantee ALCOA+ data integrity.
- Multi-vendor instrument audit trail extraction and parsing
- Rule-based anomaly detection for deletion, abort, and timestamp changes
- Reviewer sign-off workflow with periodic review logging
- Automated exception flagging before batch release
- Comprehensive data integrity risk scoring
- Exportable regulatory review summaries for inspectors
e-Logbook & Digital Batch Records
Replaces vulnerable paper logbooks across production and QC areas with secure digital entries, QR code equipment scanning, and automated status tracking.
- Equipment usage and operational logbook entry
- Area clearance and line cleaning verification logs
- Real-time preventive maintenance and calibration alerts
- Barcode and QR code scanning for fast instrument access
- Interlock prevention for uncalibrated or unclean equipment
- Complete historical audit trail for equipment lifecycle
Stability Management & Environmental Monitoring
End-to-end management of stability testing programs from protocol definition and chamber inventory to sample pull notifications and degradation trend analysis.
- Stability protocol configuration with automated pull schedules
- Window notification alerts for sample pulls and testing due dates
- Real-time chamber temperature and humidity telemetry integration
- OOT (Out-of-Trend) regression modeling and degradation prediction
- Certificate of Analysis (CoA) generation
- Stability study summary reports for regulatory submissions
Software + Full CSV Validation Documentation in One Package
Unlike standard IT vendors who provide software without regulatory compliance papers, AdvanceTechInfo delivers every platform fully configured and paired with ready-to-execute IQ, OQ, and PQ validation protocols, Risk Assessments, and Traceability Matrices.
Request a Software Demo
See how our eQMS, eDMS, or Audit Trail Review software fits into your plant's workflows.
REQUEST DEMO & PRICING →Get a Free Consultation
Tell us about your systems. We will map them to GAMP 5 and outline the path to an audit-ready state — at no cost.