8 Best TrackWise Software Solutions in 2025
Pharmaceutical, biotechnology, and medical device companies face stringent regulatory requirements and complex quality processes. Managing these processes effectively is critical for compliance, product safety, and overall operational efficiency. TrackWise software provides a framework for handling quality events, deviations, and audits, ensuring adherence to industry standards.
This article provides a detailed comparison of eight TrackWise software solutions designed to streamline quality management in regulated industries. We will examine key features, pricing, and ideal use cases to help you select the best platform for your organization. The goal is to provide a comprehensive resource for navigating the TrackWise software landscape.
Why is TrackWise Software Needed?
The pharmaceutical, biotechnology, and medical device sectors operate under intense scrutiny from regulatory bodies such as the FDA and EMA. Maintaining product quality and adhering to strict guidelines are paramount to avoiding costly recalls, legal repercussions, and damage to brand reputation. Many organizations struggle with manual, paper-based systems or disparate software solutions that create inefficiencies and increase the risk of errors.
- Inconsistent Data Management: Using multiple, disconnected systems leads to data silos, making it difficult to track and analyze quality data across the organization. This can result in incomplete or inaccurate information, hindering decision-making.
- Inefficient Workflow Automation: Manual processes for handling deviations, CAPAs (Corrective and Preventive Actions), and audits are time-consuming and prone to human error. This slows down response times and increases the risk of non-compliance.
- Lack of Real-Time Visibility: Without a centralized system, it’s challenging to gain real-time insights into quality metrics and identify potential issues before they escalate. This lack of visibility can lead to reactive rather than proactive quality management.
- Difficulty Meeting Regulatory Requirements: Maintaining compliance with regulations like 21 CFR Part 11 and EU GMP Annex 11 requires robust audit trails, electronic signatures, and data integrity controls. Manual systems struggle to meet these requirements effectively.
- Increased Risk of Errors and Omissions: Manual data entry and paper-based processes increase the likelihood of errors, omissions, and inconsistencies, which can compromise product quality and regulatory compliance.
TrackWise software offers a centralized, automated solution for managing quality processes, ensuring data integrity, and facilitating compliance. By streamlining workflows and providing real-time visibility, TrackWise helps organizations improve efficiency, reduce risks, and maintain the highest standards of quality.
Key Features to Look For
Selecting the right TrackWise software requires careful consideration of key features that align with your organization’s specific needs and regulatory requirements.
Deviation Management:
A robust deviation management module allows for the efficient tracking, investigation, and resolution of deviations from established procedures or specifications. This includes capturing all relevant information, assigning responsibilities, and implementing corrective actions.
CAPA Management:
Corrective and Preventive Action (CAPA) management is crucial for addressing root causes of quality issues and preventing recurrence. The software should facilitate the identification, investigation, implementation, and verification of CAPAs, ensuring effective problem-solving.
Audit Management:
An integrated audit management module streamlines the planning, execution, and reporting of internal and external audits. This includes scheduling audits, tracking findings, and managing corrective actions resulting from audit observations.
Document Control:
Effective document control is essential for maintaining accurate and up-to-date documentation. The software should provide version control, approval workflows, and electronic signatures to ensure document integrity and compliance.
Training Management:
A comprehensive training management system helps ensure that employees are adequately trained on relevant procedures and regulations. This includes tracking training records, managing training schedules, and assessing training effectiveness.
Benefits
Implementing TrackWise software offers several benefits for organizations operating in regulated industries, improving quality management and operational efficiency.
Improved Compliance:
TrackWise helps organizations meet regulatory requirements such as 21 CFR Part 11 and EU GMP Annex 11 by providing robust audit trails, electronic signatures, and data integrity controls. This reduces the risk of regulatory citations and ensures compliance.
Increased Efficiency:
Automating quality processes, such as deviation management and CAPA, streamlines workflows and reduces manual effort. This improves efficiency, allowing organizations to focus on other critical tasks.
Enhanced Visibility:
TrackWise provides real-time visibility into quality metrics and performance, enabling organizations to identify potential issues early and take proactive measures. This enhances decision-making and improves overall quality management.
Reduced Costs:
By automating processes and reducing errors, TrackWise helps organizations reduce costs associated with quality issues, such as recalls, rework, and regulatory fines. This improves profitability and strengthens the bottom line.
Better Data Integrity:
TrackWise ensures data integrity by providing secure data storage, access controls, and audit trails. This minimizes the risk of data manipulation and ensures the reliability of quality data.
What Are the Top TrackWise Solutions?
Veeva Vault QualityDocs – Best for Cloud-Based Document Management
Veeva Vault QualityDocs is a cloud-based document management system designed specifically for the life sciences industry. It provides a centralized platform for managing documents, streamlining workflows, and ensuring compliance with regulatory requirements. Veeva Vault QualityDocs offers a secure and scalable solution for organizations of all sizes, enabling them to improve efficiency and reduce the risk of errors.
Veeva Vault QualityDocs offers a range of features including version control, approval workflows, and electronic signatures. It also integrates with other Veeva Vault applications, such as Veeva Vault QMS and Veeva Vault Training, to provide a comprehensive quality management solution. The system is designed to be user-friendly and intuitive, making it easy for users to adopt and use effectively.
The platform enables organizations to manage all types of documents, from standard operating procedures (SOPs) to batch records. It also provides robust search capabilities, allowing users to quickly find the information they need. Veeva Vault QualityDocs supports collaboration by enabling users to share documents and provide feedback in real-time. It is also designed to meet the stringent security and compliance requirements of the life sciences industry.
Compared to solutions like MasterControl, which offers broader QMS capabilities, Veeva Vault QualityDocs specializes in document management, offering deeper functionality in this area. While ComplianceQuest provides a more comprehensive suite of QMS applications, Veeva Vault QualityDocs is often preferred for its ease of use and integration with other Veeva products.
Key Features:
- Version control for managing document revisions
- Approval workflows for automating document review and approval
- Electronic signatures for ensuring document integrity
- Audit trails for tracking document changes
- Integration with other Veeva Vault applications
Pricing:
Starting at $25,000/year
Free plan: Not Available
Premium: Contact Sales
Enterprise: Contact Sales
Best For: Life sciences companies looking for a cloud-based document management system that integrates with other Veeva Vault applications.
MasterControl Quality Excellence – Best for Comprehensive QMS
MasterControl Quality Excellence is a comprehensive quality management system (QMS) designed to help organizations in regulated industries streamline their quality processes and ensure compliance. It provides a centralized platform for managing documents, training, audits, and other quality-related activities. MasterControl is known for its robust functionality and scalability, making it suitable for organizations of all sizes.
MasterControl offers a range of modules, including document control, CAPA management, audit management, and training management. It also provides advanced features such as risk management, supplier management, and electronic batch records. The system is designed to be highly configurable, allowing organizations to tailor it to their specific needs and workflows. MasterControl’s integrated platform helps organizations maintain data integrity, improve efficiency, and reduce the risk of errors.
The platform is designed to meet the stringent requirements of regulatory agencies such as the FDA and EMA. It provides robust audit trails, electronic signatures, and data validation features to ensure compliance with regulations like 21 CFR Part 11 and EU GMP Annex 11. MasterControl also offers validation services to help organizations implement and validate the system effectively.
Compared to Veeva Vault QualityDocs, MasterControl provides a broader range of QMS capabilities, including document management, CAPA management, and audit management. While ComplianceQuest offers similar functionality, MasterControl is often preferred for its established reputation and extensive customer base.
Key Features:
- Document control for managing document revisions and approvals
- CAPA management for tracking and resolving quality issues
- Audit management for planning and executing audits
- Training management for tracking employee training records
- Risk management for identifying and mitigating potential risks
Pricing:
Starting at $30,000/year
Free plan: Not Available
Premium: Contact Sales
Enterprise: Contact Sales
Best For: Regulated companies seeking a comprehensive QMS solution with robust functionality and scalability.
ComplianceQuest EQMS – Best for AI-Powered Quality Management
ComplianceQuest EQMS (Enterprise Quality Management System) is a cloud-based platform that leverages artificial intelligence (AI) to automate and optimize quality processes. It offers a comprehensive suite of applications for managing documents, CAPAs, audits, training, and other quality-related activities. ComplianceQuest is designed to help organizations improve efficiency, reduce costs, and ensure compliance with regulatory requirements.
ComplianceQuest EQMS provides a range of features, including AI-powered document classification, predictive analytics for identifying potential quality issues, and automated workflows for streamlining processes. It also integrates with other enterprise systems, such as ERP and CRM, to provide a holistic view of quality across the organization. The system is designed to be user-friendly and intuitive, making it easy for users to adopt and use effectively.
The platform’s AI capabilities enable organizations to automate tasks such as document review, data analysis, and risk assessment. It also provides real-time insights into quality metrics, allowing organizations to identify trends and take proactive measures to prevent issues. ComplianceQuest EQMS is designed to meet the stringent requirements of regulatory agencies such as the FDA and EMA.
Unlike MasterControl, which has a longer history in the QMS space, ComplianceQuest leverages AI to offer advanced capabilities. While Veeva Vault QualityDocs focuses primarily on document management, ComplianceQuest provides a broader range of QMS applications with AI-driven features.
Key Features:
- AI-powered document classification
- Predictive analytics for identifying potential quality issues
- Automated workflows for streamlining processes
- Integration with other enterprise systems
- Real-time insights into quality metrics
Pricing:
Starting at $20,000/year
Free plan: Not Available
Premium: Contact Sales
Enterprise: Contact Sales
Best For: Companies that want to leverage AI to automate and optimize their quality processes.
Sparta Systems TrackWise – Best for Enterprise-Wide Quality Management
Sparta Systems TrackWise is a well-established enterprise quality management system (EQMS) designed to manage quality events, deviations, and audits across an organization. With a long history in the life sciences industry, it provides a robust and configurable platform for streamlining quality processes and ensuring compliance with regulatory requirements. TrackWise is particularly well-suited for large, complex organizations with demanding quality management needs.
TrackWise offers a comprehensive set of features, including deviation management, CAPA management, audit management, and change control. It also provides advanced capabilities such as supplier quality management, product lifecycle management (PLM) integration, and electronic batch recording. The system is designed to be highly configurable, allowing organizations to tailor it to their specific needs and workflows. TrackWise is an on-premise solution, offering more control over data and infrastructure.
The platform’s configurable workflows and robust reporting capabilities enable organizations to track and analyze quality data across the enterprise. It also provides advanced security features to protect sensitive information and ensure data integrity. TrackWise is designed to meet the stringent requirements of regulatory agencies such as the FDA and EMA.
Compared to cloud-based solutions like ComplianceQuest, TrackWise offers greater control over data and infrastructure, but may require more IT resources to manage. While MasterControl provides similar functionality, TrackWise is often preferred for its established reputation and extensive customization options.
Key Features:
- Deviation management for tracking and resolving deviations from established procedures
- CAPA management for identifying and implementing corrective and preventive actions
- Audit management for planning and executing audits
- Change control for managing changes to products, processes, and systems
- Supplier quality management for monitoring and managing supplier performance
Pricing:
Starting at $40,000/year
Free plan: Not Available
Premium: Contact Sales
Enterprise: Contact Sales
Best For: Large, complex organizations with demanding quality management needs and a preference for on-premise solutions.
Pilgrim Quality Management Suite – Best for Process Manufacturing
Pilgrim Quality Management Suite is a comprehensive QMS designed specifically for process manufacturing industries, including food and beverage, chemicals, and pharmaceuticals. It provides a centralized platform for managing quality processes, ensuring compliance, and improving operational efficiency. Pilgrim QMS is known for its robust functionality and industry-specific features.
Pilgrim offers a range of modules, including document control, CAPA management, audit management, and training management. It also provides advanced features such as supplier quality management, product risk management, and complaint management. The system is designed to be highly configurable, allowing organizations to tailor it to their specific needs and workflows.
The platform’s industry-specific features enable organizations to meet the unique challenges of process manufacturing, such as managing batch records, tracking raw materials, and ensuring product traceability. It also provides robust reporting capabilities, allowing organizations to track and analyze quality data across the enterprise. Pilgrim QMS is designed to meet the stringent requirements of regulatory agencies such as the FDA and EMA.
Compared to generic QMS solutions like ComplianceQuest, Pilgrim offers industry-specific features tailored to the needs of process manufacturing. While MasterControl provides similar functionality, Pilgrim is often preferred for its expertise in process manufacturing and its ability to address the unique challenges of these industries.
Key Features:
- Document control for managing document revisions and approvals
- CAPA management for tracking and resolving quality issues
- Audit management for planning and executing audits
- Training management for tracking employee training records
- Supplier quality management for monitoring and managing supplier performance
Pricing:
Starting at $35,000/year
Free plan: Not Available
Premium: Contact Sales
Enterprise: Contact Sales
Best For: Process manufacturing companies looking for a QMS solution with industry-specific features.
MetricStream Quality Management – Best for Integrated Risk and Compliance
MetricStream Quality Management is a comprehensive QMS designed to integrate quality management with risk and compliance processes. It provides a centralized platform for managing documents, CAPAs, audits, training, and other quality-related activities, while also addressing risk and compliance requirements. MetricStream is known for its integrated approach and its ability to provide a holistic view of quality, risk, and compliance.
MetricStream offers a range of modules, including document control, CAPA management, audit management, and training management. It also provides advanced features such as risk assessment, compliance management, and incident management. The system is designed to be highly configurable, allowing organizations to tailor it to their specific needs and workflows.
The platform’s integrated approach enables organizations to identify and mitigate risks associated with quality issues, while also ensuring compliance with regulatory requirements. It also provides robust reporting capabilities, allowing organizations to track and analyze quality, risk, and compliance data across the enterprise. MetricStream Quality Management is designed to meet the stringent requirements of regulatory agencies such as the FDA and EMA.
Unlike point solutions that focus solely on quality management, MetricStream offers an integrated approach that addresses risk and compliance as well. While MasterControl provides similar functionality, MetricStream is often preferred for its expertise in integrated risk and compliance management.
Key Features:
- Document control for managing document revisions and approvals
- CAPA management for tracking and resolving quality issues
- Audit management for planning and executing audits
- Training management for tracking employee training records
- Risk assessment for identifying and mitigating potential risks
Pricing:
Starting at $28,000/year
Free plan: Not Available
Premium: Contact Sales
Enterprise: Contact Sales
Best For: Organizations seeking an integrated QMS solution that addresses risk and compliance requirements.
AssurX CATSWeb – Best for Small to Medium-Sized Businesses
AssurX CATSWeb is a QMS designed for small to medium-sized businesses (SMBs) in regulated industries. It offers a user-friendly platform for managing documents, CAPAs, audits, and other quality-related activities. AssurX CATSWeb is known for its affordability and ease of use, making it a good choice for SMBs that need a basic QMS solution.
AssurX CATSWeb provides a range of features, including document control, CAPA management, audit management, and training management. It also offers advanced features such as supplier quality management and complaint management. The system is designed to be easy to implement and use, with a simple and intuitive interface.
The platform’s affordability makes it a good choice for SMBs that have limited budgets. It also provides robust reporting capabilities, allowing organizations to track and analyze quality data across the enterprise. AssurX CATSWeb is designed to meet the requirements of regulatory agencies such as the FDA and EMA.
Compared to more complex QMS solutions like MasterControl, AssurX CATSWeb offers a simpler and more affordable option for SMBs. While ComplianceQuest provides similar functionality, AssurX CATSWeb is often preferred for its ease of use and its focus on the needs of SMBs.
Key Features:
- Document control for managing document revisions and approvals
- CAPA management for tracking and resolving quality issues
- Audit management for planning and executing audits
- Training management for tracking employee training records
- Supplier quality management for monitoring and managing supplier performance
Pricing:
Starting at $15,000/year
Free plan: Not Available
Premium: Contact Sales
Enterprise: Contact Sales
Best For: Small to medium-sized businesses seeking an affordable and easy-to-use QMS solution.
Qualio eQMS – Best for Fast-Growing Startups
Qualio eQMS is a cloud-based QMS designed specifically for fast-growing startups in the life sciences industry. It provides a user-friendly platform for managing documents, CAPAs, audits, and other quality-related activities. Qualio is known for its ease of use, rapid implementation, and its ability to scale with the needs of growing companies.
Qualio offers a range of features, including document control, CAPA management, audit management, and training management. It also provides advanced features such as risk management, supplier management, and electronic batch records. The system is designed to be easy to implement and use, with a modern and intuitive interface.
The platform’s rapid implementation capabilities enable startups to quickly deploy a QMS and begin managing their quality processes. It also provides robust reporting capabilities, allowing organizations to track and analyze quality data across the enterprise. Qualio eQMS is designed to meet the stringent requirements of regulatory agencies such as the FDA and EMA.
Compared to more complex QMS solutions like MasterControl, Qualio offers a simpler and more agile solution for startups. While AssurX CATSWeb provides a similar level of simplicity, Qualio is often preferred for its modern interface and its focus on the needs of fast-growing companies.
Key Features:
- Document control for managing document revisions and approvals
- CAPA management for tracking and resolving quality issues
- Audit management for planning and executing audits
- Training management for tracking employee training records
- Risk management for identifying and mitigating potential risks
Pricing:
Starting at $18,000/year
Free plan: Not Available
Premium: Contact Sales
Enterprise: Contact Sales
Best For: Fast-growing startups in the life sciences industry seeking an agile and easy-to-use QMS solution.
TrackWise Software Comparison
Here’s a side-by-side comparison of the top solutions.
| Software | Best For | Starting Price | Key Features | Integrations | Free Plan |
|---|---|---|---|---|---|
| Veeva Vault QualityDocs | Cloud-Based Document Management | $25,000/year | Version Control, Approval Workflows | Veeva Vault Applications | No |
| MasterControl Quality Excellence | Comprehensive QMS | $30,000/year | Document Control, CAPA Management | ERP, CRM | No |
| ComplianceQuest EQMS | AI-Powered Quality Management | $20,000/year | AI-Powered Document Classification, Predictive Analytics | ERP, CRM | No |
| Sparta Systems TrackWise | Enterprise-Wide Quality Management | $40,000/year | Deviation Management, CAPA Management | PLM, ERP | No |
| Pilgrim Quality Management Suite | Process Manufacturing | $35,000/year | Batch Records, Raw Material Tracking | ERP, MES | No |
| MetricStream Quality Management | Integrated Risk and Compliance | $28,000/year | Risk Assessment, Compliance Management | GRC, ERP | No |
| AssurX CATSWeb | Small to Medium-Sized Businesses | $15,000/year | Document Control, CAPA Management | CRM, Accounting | No |
| Qualio eQMS | Fast-Growing Startups | $18,000/year | Rapid Implementation, User-Friendly Interface | Slack, Google Workspace | No |
How to Choose the Right TrackWise Software
Selecting the appropriate TrackWise software requires a systematic approach that considers your organization’s specific needs, regulatory requirements, and budget.
Assess Your Specific Needs:
Begin by identifying your organization’s specific quality management needs. Consider the types of quality events you need to manage, the regulatory requirements you must meet, and the size and complexity of your organization.
Evaluate Integration Requirements:
Determine the systems with which the TrackWise software must integrate. This may include ERP systems, CRM systems, manufacturing execution systems (MES), and other enterprise applications. Ensure that the software offers the necessary integrations to streamline workflows and data sharing.
Consider User Experience:
Choose software that is user-friendly and intuitive, with a modern and easy-to-navigate interface. A positive user experience will encourage adoption and improve efficiency.
Check Scalability Options:
Ensure that the TrackWise software can scale with your organization’s growth. The software should be able to handle increasing volumes of data and users without compromising performance.
Review Pricing Models:
Compare the pricing models of different TrackWise software solutions. Consider the total cost of ownership, including implementation costs, maintenance fees, and training expenses.
Test with Free Trials:
Take advantage of free trials or demos to test the software and ensure that it meets your organization’s needs. This will allow you to evaluate the software’s functionality, ease of use, and integration capabilities.
Read Reviews & Case Studies:
Research customer reviews and case studies to learn about the experiences of other organizations that have used the software. This can provide valuable insights into the software’s strengths and weaknesses.
TrackWise Software Best Practices
To maximize the benefits of TrackWise software, it’s essential to follow best practices for implementation, configuration, and ongoing management.
Start with Clear Requirements:
Define clear and specific requirements for the TrackWise software. This will help ensure that the software is configured to meet your organization’s unique needs and regulatory requirements.
Involve Key Stakeholders Early:
Involve key stakeholders from different departments in the selection and implementation process. This will help ensure that the software meets the needs of all users and that everyone is aligned on the goals and objectives of the project.
Plan for Proper Training:
Provide comprehensive training to all users of the TrackWise software. This will help ensure that everyone understands how to use the software effectively and that they are able to perform their job duties efficiently.
Monitor Adoption Metrics:
Track adoption metrics to monitor the usage of the TrackWise software. This will help you identify areas where users may need additional training or support.
Leverage Automation Features:
Take advantage of the automation features of the TrackWise software to streamline workflows and reduce manual effort. This will improve efficiency and reduce the risk of errors.
Maintain Data Quality:
Implement processes to ensure the quality and accuracy of data entered into the TrackWise software. This will help ensure that the data is reliable and that it can be used to make informed decisions.
Schedule Regular Reviews:
Schedule regular reviews of the TrackWise software to ensure that it continues to meet your organization’s needs. This will help you identify areas where the software may need to be updated or reconfigured.
Finding Your Perfect Solution
Selecting the right TrackWise software is a critical decision that can significantly impact an organization’s quality management processes and regulatory compliance. By carefully evaluating your needs, considering key features, and following best practices, you can choose a solution that streamlines workflows, reduces risks, and improves overall efficiency. Solutions like MasterControl and ComplianceQuest offer strong capabilities, but the ideal choice depends on your unique requirements.
FAQ
What is TrackWise software?
TrackWise software is a type of enterprise quality management system (EQMS) used by regulated industries, such as pharmaceuticals and medical devices, to manage quality events, deviations, and audits, ensuring compliance with regulatory requirements.
What are the key features of TrackWise software?
Key features typically include document control, CAPA management, audit management, training management, deviation management, and supplier quality management, all designed to streamline quality processes and maintain data integrity.
How does TrackWise software help with regulatory compliance?
TrackWise software provides robust audit trails, electronic signatures, and data integrity controls that help organizations meet regulatory requirements such as 21 CFR Part 11 and EU GMP Annex 11, reducing the risk of regulatory citations.
What is the cost of TrackWise software?
The cost of TrackWise software varies depending on the vendor, the size of the organization, and the features required. Pricing models typically involve annual subscription fees or perpetual licenses with ongoing maintenance fees, ranging from $15,000 to $40,000 annually.
Is TrackWise software suitable for small businesses?
While some TrackWise solutions are designed for large enterprises, there are also options available for small to medium-sized businesses (SMBs) that offer a more affordable and user-friendly platform.
What are the benefits of using TrackWise software?
The benefits of using TrackWise software include improved compliance, increased efficiency, enhanced visibility, reduced costs, and better data integrity, leading to improved quality management and operational performance.
