MasterControl Quality Excellence
Connecting quality and manufacturing for accelerated product development.
Overview
MasterControl is a well-established QMS platform used extensively by pharmaceutical, biotech, and medical device companies. It offers robust, integrated modules for document control, CAPA, audit management, and training to ensure compliance with FDA and ISO standards.
✨ Key Features
- Document Control
- CAPA Management
- Training Management
- Audit Management
- Change Control
- Supplier Management
- Risk Management
- Electronic Batch Records (EBR)
🎯 Key Differentiators
- Integrated platform for QMS, MES, and asset management
- Deep focus on life sciences and regulated industries
- AI-driven analytics and process optimization
Unique Value: Provides a single, unified platform for quality, manufacturing, and asset management, specifically designed to meet the stringent regulatory requirements of the life sciences industry.
🎯 Use Cases (4)
✅ Best For
- Widely used in pharma and biotech for its scalability and Part 11 compliance.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Can be inflexible for teams with unique SOPs or rapidly evolving processes.
🏆 Alternatives
Offers a more comprehensive, integrated solution compared to point solutions that only address specific aspects of quality management.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Live Chat
- ✓ Phone Support
- ✓ Dedicated Support (Varies tier)
🔒 Compliance & Security
💰 Pricing
🔄 Similar Tools in 503B Compliance
Qualio
A cloud-based QMS for pharma, biotech, and medical device companies, focusing on startups and scale-...
Veeva Vault QMS
An enterprise-scale QMS, part of the broader Veeva Vault suite for life sciences....
ETQ Reliance
A modular QMS platform used across various regulated industries, including life sciences....
ComplianceQuest
An AI-powered EQMS built on the Salesforce platform, serving various industries including life scien...
InstantGMP PRO
Cloud-based electronic batch record and quality system software designed for GMP-regulated industrie...
AssurX
A QMS platform that automates and streamlines quality and compliance processes....