MasterControl Deviation Management
Streamlining Deviation Management for Improved Product Quality and Compliance.
Overview
MasterControl's deviation management software is a comprehensive solution designed for regulated industries to efficiently document, investigate, and resolve product and process deviations. It provides a centralized platform to automate the entire deviation lifecycle, from initiation and investigation to corrective actions and closure. The software helps ensure compliance with regulations such as FDA 21 CFR Part 11 and ISO standards by providing features like electronic signatures, audit trails, and robust reporting. Its integration with other quality processes like CAPA and nonconformance management creates a closed-loop quality system.
✨ Key Features
- Automated deviation lifecycle management
- Centralized data and documentation
- Root cause analysis tools
- Integration with CAPA and nonconformance systems
- Electronic signatures and audit trails
- Advanced reporting and analytics
- Forms and workflow automation
🎯 Key Differentiators
- Closed-loop quality system with integrated modules
- Focus on life sciences and other highly regulated industries
- Long-standing reputation and industry expertise
Unique Value: Provides a comprehensive, integrated QMS platform that streamlines compliance and improves quality throughout the product lifecycle.
🎯 Use Cases (5)
✅ Best For
- Pharmaceutical and medical device manufacturing
- Biotechnology
- Contract manufacturing organizations (CMOs)
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Very small businesses with minimal compliance needs
- Industries without stringent regulatory requirements
🏆 Alternatives
Offers a more holistic and integrated approach to quality management compared to point solutions.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Live Chat
- ✓ Phone Support
- ✓ Dedicated Support (Enterprise tier)
🔒 Compliance & Security
💰 Pricing
Free tier: N/A
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