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New Release

QualityGate

GMP quality management system for pharmaceutical manufacturers. Electronic SOPs with structured multi-step execution, GMP logbooks, CAPA management, multi-step electronic approval workflows, and a complete audit trail. Built for FDA 21 CFR Part 11 and GMP compliance.

Production Ready
security Enterprise Grade
lock https://qualitygate.itac.internal
ITAC
QualityGate v2.4
Live Workspace
System Operational
Latency
14ms
↓ 2ms faster
Sync Mode
Offline P2P
Real-time stream
Security
verified_user Enforced
AES-256 / SSL
Transaction Throughput 99.98% Uptime

Technical Scalability

QualityGate is architected for enterprise-scale deployments. Horizontal scaling and integration are first-class concerns.

Deployment Options

On-prem Cloud
Core Features

Key Capabilities

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Electronic SOP authoring with structured versioned steps and linked forms
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Multiple step types: Yes/No checks, numeric measurements, text entries, choice lists
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GMP electronic logbooks with structured entry templates
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CAPA management with corrective/preventive action tracking
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Multi-step electronic approval workflows with configurable chains
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Task execution engine — operators execute SOPs on screen with time-stamps
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Complete audit trail with automatic change detection
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Data integrity: record versioning with SHA-256 hashing
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Product and batch management with manufacture/expiry dates
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Bilingual interface: Arabic and English with full RTL support
Methodology

How it works

  1. 1

    Quality managers author SOPs as structured, versioned steps with linked forms and header fields

  2. 2

    SOPs are linked to specific products, rooms, and equipment in the organizational hierarchy

  3. 3

    Operators execute SOPs on screen, every step response and measured value is time-stamped and recorded

  4. 4

    If a deviation is detected, a CAPA record is raised with priority, root cause, and corrective actions

  1. 5

    Reviewers and quality managers approve task executions through multi-step electronic workflows

  2. 6

    Every change across the system is captured in a complete audit trail with SHA-256 record integrity verification

  3. 7

    Management dashboards show SOP compliance rates, open CAPAs, pending approvals, and batch status

Architecture

A robust, synchronized ecosystem.

Designed for reliability in zero-connectivity environments and high-volume transaction processing.

smartphone

Device Client

QualityGate App

OFFLINE_DB
BIOMETRIC_AUTH
api REST API
dns

Central Hub

ITAC Enterprise

REDIS_CACHE
SQL_SERVER

See QualityGate in action.

A 30-minute walkthrough with a solutions architect who knows your sector.

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