GxP Applications
Comprehensive GxP application development and validation services that ensure regulatory compliance and data integrity across pharmaceutical systems and critical business processes.
Audit-ready. Pharma-perfect.
Q-Docx.
The complete GxP Document Management System designed for pharmaceutical
compliance — streamline document workflows with enterprise-grade security and
regulatory rigor.
21 CFR Part 11
Electronic records and signatures done right.
Data Integrity
ALCOA+ aligned controls across every workflow.
GAMP 5
Risk-based, validated software
built for pharma.
Audit Ready
Inspector-friendly evidence,
always at hand.
A unified suite for GxP
operations.
Access purpose-built modules for comprehensive system control across
documents, training, validation, quality, and the shop floor
Document Management
Learning Management
Role-based training with assessments, certifications, and auto-retraining on SOP changes.
Validation Lifecycle
End-to-end validation planning, execution, and evidence with risk-based traceability.
Quality Management
CAPA, deviations, and change control unified with compliant approvals and audit trails.
Market Complaint
Intake-to-closure complaint handling with root-cause, trending, and regulatory reporting.
Material Management
Spec-to-release control with CoA linkage, status tracking, and genealogy.
Manufacturing Execution
Real-time production monitoring, quality control, and compliance tracking.
Excel Workflow Automation
Governed spreadsheet processes with templates, validations, and controlled approvals.
IT/OT Integration
Secure bridge from shop-floor to cloud for real-time events, records, and alarms.
Audit & Compliance
Built for regulators. Loved by
operators.
Every module is engineered with risk-based validation, ALCOA+ data integrity, and inspector-ready evidence — so your team focuses on quality, not paperwork.
GAMP 5 risk-based development lifecycle
21 CFR Part 11 electronic records & signatures
EU Annex 11 aligned controls
Granular role-based access and audit trails
Validated templates and traceability matrices
Modernize your GxP stack with confidence.
Talk to our validation experts about deploying Q-Docx and the wider GxP
module suite across your organization.