TrackWise and MasterControl frequently appear in quality management system (QMS) discussions within regulated industries.
Teams look to them for audit readiness, consistent processes, and dependable execution. Choosing between them sets expectations for how quality work will operate.
Differences show up once teams rely on the system in routine workflows. Design choices influence how people interact with the software and complete required tasks.
This article takes a close look at TrackWise and MasterControl so you can see how each platform performs during regular quality work and audit preparation.
TL;DR
- TrackWise uses fixed workflows, while MasterControl offers more configurable workflows.
- Both platforms require extensive setup and validation, as well as ongoing system ownership.
- Daily use is often limited to quality specialists rather than the wider organization.
- Many teams evaluating both choose TLM for a faster and more accessible QMS.
What Is TrackWise?
Image source: trackwise.com
TrackWise is quality management software used in regulated industries, especially the life sciences.
Medical device companies and pharmaceutical manufacturers use it to manage audits, investigations, and compliance records.
The platform comes in two versions. One is a legacy on-premises system. The other is TrackWise Digital, the cloud version that runs on Salesforce.
Some organizations use both to extend existing workflows while adding cloud access and mobile use.
TrackWise manages quality events inside one quality management system. Users document issues, corrective and preventive actions (CAPAs), and regulatory records without relying on office documents.
Key Features
- Complaint management with investigation workflows and audit trail
- TrackWise Digital AI features for auto-categorization and auto-summarization
- Reporting and analytics through QualityView
- Risk management templates used by life science companies
- Supplier management with audits and corrective actions
- Document control with electronic records, electronic signatures, and 21 CFR Part 11 support
- Integration with enterprise resource planning (ERP), product lifecycle management (PLM), and customer relationship management (CRM) systems
Platform Capabilities
TrackWise supports organizations that run frequent internal and external audits. It provides workflows for CAPA, complaints, and investigations.
Quality groups often rely on it to manage documentation and approvals inside one compliance software platform.
TrackWise Digital adds AI tools that reduce manual data entry. QualityView helps users review quality data without exporting reports. Salesforce supports security and connections with other enterprise systems.
Implementation Considerations
TrackWise often requires extensive setup and computer system validation. This includes installation qualification, operational qualification, and performance qualification.
Ongoing administration usually requires dedicated system owners or consultants.
User adoption often stays within the quality group. Occasional users may need training to complete tasks. Document management often relies on external systems such as SharePoint or Documentum.
What Is MasterControl?
Image source: mastercontrol.com
MasterControl is quality management software commonly used in pharmaceutical and medical device companies.
Organizations use it to manage quality and compliance processes related to audits, documentation, and training.
The platform combines a QMS with manufacturing and asset management modules. This setup places quality, production, and maintenance records in one environment rather than separate systems.
MasterControl Quality Excellence refers to the quality management portion of the platform.
The system is typically used by organizations that manage formal quality processes under regulatory oversight and inspection activity.
Key Features
- Quality event handling for deviations, CAPA management, change control, and issue review
- Advanced quality event management with configurable forms and routing
- Document management for controlled documents, version history, and electronic signatures
- Training management linked to quality documents and procedures
- Audit management with task lists and notifications
- Validation on demand for configured workflows
- Artificial intelligence tools for trend detection and document review
- Reporting and data analysis through premium insights
- Integration capabilities with manufacturing systems and other enterprise systems
Platform Capabilities
MasterControl supports configurable workflows for deviations, customer complaints, and CAPA. Data entered during events feeds into reports used for review and audit preparation.
Training management links procedures with employee records. Auditors can review training history and document versions during inspections without pulling data from other systems.
Implementation Considerations
Setting up MasterControl requires computer system validation, including installation, operational, and performance qualification.
An implementation team typically manages configuration and validation tasks.
User adoption varies outside quality roles. The user interface relies on structured forms with limited formatting, which some users find restrictive. Interruptions during data entry have also been reported.
Software cost depends on the selected modules. Organizations often license multiple modules to cover audit management, training management, and document control.
Key Differences Between TrackWise and MasterControl
TrackWise and MasterControl are often grouped as enterprise quality management solutions. Both support regulated environments and formal audits.
The differences show up in how each system supports business processes and regulatory work.
Design Controls and Quality Events
TrackWise relies on predefined workflows for complaints, deviations, and CAPA. These workflows follow fixed paths and support consistent review cycles.
This model fits organizations that prefer stable review processes.
MasterControl focuses on configurable quality event management. Users can adjust forms, routing rules, and fields as requirements change.
This changes how organizations manage customer feedback and issue reviews.
Document Control and Training Management
TrackWise supports document control but often connects to external document platforms. Training records usually exist outside the main quality workflows.
MasterControl keeps document control and training management inside one compliance suite. Controlled documents, training records, and approvals stay connected, which affects how audits are prepared and reviewed.
Reporting and Risk Review
TrackWise uses QualityView to review quality data. Reporting focuses on trends within quality events and audits.
MasterControl uses premium insights for reporting and risk assessment. Reports can include quality events, documents, and training records in one view.
This supports reviews against quality standards and industry standards.
Implementation and System Scope
TrackWise implementations often follow established patterns used by large enterprises. Setup and validation take time, especially when legacy systems remain in use.
MasterControl implementations vary significantly depending on the number of licensed modules. Adding modules for training, documents, and audits increases the system’s scope and the rollout effort.
User Experience and System Ownership
TrackWise emphasizes organized workflows and formal reviews. Daily interaction often stays within quality roles rather than the full organization.
MasterControl places more emphasis on configuration and breadth. Users describe the user interface as rigid, especially during data entry.
System ownership and customer support typically require dedicated internal resources.
Quality Management Gaps in TrackWise and MasterControl
TrackWise and MasterControl meet core expectations for regulatory compliance. Each platform manages audits, documentation, and formal quality workflows within a single system.
The gap appears during implementation and ongoing use. Setup and validation require time and specialized ownership.
Maintaining compliance often depends on a small group of experienced users rather than broad participation throughout the organization.
Usability adds another challenge. Many features address specialized scenarios rather than routine quality tasks.
The user interface can feel restrictive, which reduces how often non-quality roles interact with the system.
As a result, some organizations continue evaluating other electronic quality management system (eQMS) vendors after comparing TrackWise and MasterControl.
This is often where options like TLM start to come up in discussions.
What TLM Does Differently Than TrackWise and MasterControl
Total Lean Management (TLM) often comes up after organizations compare TrackWise and MasterControl and ask one question: What qualifies as the best quality management software for audits and quality work?
TLM presents a complete suite for International Organization for Standardization (ISO) and Food and Drug Administration (FDA) audits. Participation extends beyond the quality group.
People interact with the system in different ways. Advanced users handle audits, configuration, risk, and design controls in the main application.
Others use a user-friendly interface in the web app for training, approvals, CAPA tasks, and feedback. Unlimited web access removes common barriers and keeps compliance tasks moving.
Rapid implementation sets it apart. Existing documents, records, and templates move into the system instead of being rebuilt, which shortens setup time.
Template procedures support common ISO standards, and validation templates address medical device requirements.
TLM covers product quality, risk, supplier, and change management without forcing unused or niche features into everyday work. Other modules come into use only when needed.
Schedule a demo or start the 30-day free trial to see how quickly your QMS can work for your organization!
FAQs About Trackwise vs. MasterControl
What are the benefits of using TrackWise?
TrackWise helps organizations ensure compliance by managing audits, deviations, CAPAs, and investigations in one system. The software’s features support formal workflows and audit trails that regulators expect.
Is MasterControl a PLM system?
MasterControl isn’t a product lifecycle management (PLM) system. It focuses on quality, documents, training, and audits rather than full product development workflows.
Some organizations use it alongside PLM tools when managing regulated products or clinical trials.
How much does MasterControl cost?
MasterControl does not disclose its pricing publicly.
Is MasterControl an EDM?
MasterControl includes electronic document management (EDM) as part of its quality platform. It handles version control, approvals, and electronic signatures to ensure compliance.
It’s not intended to replace a standalone EDM used outside quality processes.
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