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Quality Management System

MasterControl Quality Excellence

Enterprise-grade QMS for regulated industries ensuring compliance and operational excellence

HIPAA, SOC 2 Type II
ISO 13485, ISO 9001
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Category
Software
Ideal For
Pharmaceutical Companies
Deployment
Cloud / On-premise / Hybrid
Integrations
150++ Apps
Security
Role-based access control, audit trails, encryption in transit and at rest, multi-factor authentication
API Access
Yes - RESTful APIs for enterprise integrations

About MasterControl Quality Excellence

MasterControl Quality Excellence is a comprehensive Quality Management System (QMS) purpose-built for highly regulated industries including pharmaceuticals, biotechnology, medical devices, and advanced manufacturing. The platform streamlines and automates critical quality processes such as document management, change control, audit management, corrective/preventive actions (CAPA), and training compliance. It enables organizations to maintain regulatory compliance with FDA 21 CFR Part 11, EU MDR, ISO 13485, and other global standards while reducing manual work and improving operational efficiency. AiDOOS enhances deployment through expert governance, seamless multi-system integrations, optimized workflows, and scalable infrastructure that grows with your organization. The platform centralizes quality data, provides real-time dashboards, and enables faster decision-making through comprehensive analytics and reporting capabilities.

Challenges It Solves

  • Maintaining compliance across multiple global regulatory frameworks while managing complex document lifecycles
  • Manual quality processes causing delays, errors, and inability to track audit trails effectively
  • Disconnected systems preventing real-time visibility into quality metrics and compliance status
  • High training burden and knowledge gaps across distributed quality teams
  • Difficulty managing change control, deviations, and CAPAs at scale

Proven Results

64
Reduced compliance audit preparation time by two-thirds
52
Decreased document management overhead and process delays
78
Improved audit readiness and regulatory inspection confidence

Key Features

Core capabilities at a glance

Document Management & Control

Centralized, version-controlled document repository with workflow automation

Eliminate manual tracking and ensure regulatory compliance documentation

Audit Management

Planned and automated audit scheduling with findings tracking

Reduce audit preparation time and improve inspection readiness

CAPA Management

Root cause analysis and corrective action workflows with deadline tracking

Close preventive actions faster and prevent recurring quality issues

Change Control

Structured workflow for evaluating and implementing quality-related changes

Mitigate risks and maintain regulatory compliance during operational changes

Training & Competency Management

Track employee training, certifications, and competency requirements

Ensure team readiness and reduce compliance violations from untrained staff

Real-Time Dashboards & Analytics

Executive visibility into KPIs, trends, and quality metrics

Enable data-driven decision making and early issue identification

Ready to implement MasterControl Quality Excellence for your organization?

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Real-World Use Cases

See how organizations drive results

Pharmaceutical Manufacturing Compliance
Pharmaceutical companies use MasterControl to manage batch records, deviation reports, and FDA inspection readiness. The system ensures GMP compliance and maintains complete audit trails for drug manufacturing processes.
89
FDA inspection readiness improved significantly
Medical Device Quality Assurance
Medical device manufacturers leverage the platform to manage design controls, risk assessments, and post-market surveillance. It ensures ISO 13485 compliance and facilitates faster product approvals.
71
Reduced time to market for new devices
Contract Manufacturing Operations
Contract manufacturers use the system to standardize quality processes across multiple client accounts while maintaining segregated audit trails and compliance documentation for each customer.
64
Streamlined multi-client quality management
Biotechnology Process Development
Biotech firms manage complex development workflows, laboratory protocols, and regulatory submissions through centralized document control and change management workflows.
58
Accelerated regulatory submission timelines

Integrations

Seamlessly connect with your tech ecosystem

S

Salesforce

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Connect quality data with CRM for customer complaint tracking and complaint-to-quality issue correlation

S

SAP

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Integrate with enterprise resource planning to link quality events with production and inventory data

O

Oracle

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Seamless ERP integration for unified quality and business process management

M

Microsoft 365

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Connect with Teams, SharePoint, and Outlook for collaborative quality workflows and notifications

T

Tableau

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Advanced analytics and visualization of quality metrics and compliance dashboards

S

ServiceNow

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Incident and change management integration for coordinated quality and IT operations

C

Custom APIs

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RESTful API support for custom integrations with legacy systems and industry-specific tools

Implementation with AiDOOS

Outcome-based delivery with expert support

Outcome-Based

Pay for results, not hours

Milestone-Driven

Clear deliverables at each phase

Expert Network

Access to certified specialists

Implementation Timeline

1
Discover
Requirements & assessment
2
Integrate
Setup & data migration
3
Validate
Testing & security audit
4
Rollout
Deployment & training
5
Optimize
Performance tuning

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Alternatives & Comparisons

Find the right fit for your needs

Capability MasterControl Quality Excellence Sparta Systems Trac… Intellect QMS IQMS Quality Manage…
Customization Excellent Excellent Excellent Excellent
Ease of Use Good Good Good Good
Enterprise Features Excellent Excellent Excellent Excellent
Pricing Fair Fair Good Fair
Integration Ecosystem Excellent Good Good Excellent
Mobile Experience Good Good Good Good
AI & Analytics Good Good Good Good
Quick Setup Fair Fair Fair Fair

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Frequently Asked Questions

Is MasterControl Quality Excellence suitable for small manufacturers?
Yes, MasterControl scales from mid-market to enterprise organizations. AiDOOS helps configure the system efficiently for smaller teams, focusing on essential quality modules without unnecessary complexity.
How does MasterControl ensure FDA 21 CFR Part 11 compliance?
The platform is built with validation frameworks, electronic signature capabilities, and immutable audit trails that meet FDA requirements. All deployments include compliance certifications and documentation.
Can MasterControl integrate with our existing ERP system?
Yes, MasterControl provides APIs and pre-built connectors for major ERPs including SAP, Oracle, and Microsoft Dynamics. AiDOOS manages integration architecture, testing, and optimization for seamless data flow.
What is the typical implementation timeline?
Cloud deployment typically takes 8-16 weeks depending on complexity and customization. On-premise deployments may take longer. AiDOOS accelerates this through proven methodologies and dedicated governance support.
Does MasterControl support multiple languages and regional regulations?
Yes, the platform supports multiple languages and regional compliance frameworks including EU MDR, Health Canada, and Australian TGA standards. AiDOOS helps tailor configurations for your specific markets.
How does MasterControl handle training documentation?
The platform includes training record management, competency tracking, and certification management. It ensures all employees maintain required certifications and generates compliance reports for audits.