Implementing an efficient Quality Management System (QMS) is no longer just an option—it’s a necessity for businesses aiming to maintain high standards, streamline operations, and comply with regulatory requirements. Whether you’re in pharmaceuticals, life sciences, or manufacturing, adopting the right QMS software can save time, reduce costs, and improve operational efficiency. With the use of TrackWise and Other QMS software in Pharma Companies, the Quality management system has become more efficient and in control.
But with so many platforms available, how do you choose the right one for your organisation? This guide will take you through key points to consider, highlight top QMS software for Pharmaceutical Industry, and explain how each feature can boost your business processes.
Why QMS Software for Pharma Industry Is Essential
Gone are the days when tracking quality processes with spreadsheets sufficed. Today’s businesses face increasingly complex regulatory requirements and global operations, making manual tracking both time-consuming and error-prone.
QMS software addresses these challenges by offering automated solutions that centralise and streamline quality management processes. For example, tools like TrackWise Digital or MasterControl make it easier to manage corrective and preventive actions (CAPA), document control, and supplier audits while ensuring compliance with FDA, ISO, and GxP standards.
Common Features of QMS Software
Here’s how QMS software supports essential business functions:
- Deviation Management – Automates tracking and record-keeping, ensuring consistent issue resolution.
- CAPA Workflows – Integrates notifications, escalations, and approvals for corrective and preventive actions.
- Audit Management – Centralises audit data with automated workflows and reporting.
- Change Control – Simplifies the process for managing changes from request to implementation.
- Training Management – Tracks document changes and training requirements for compliance.
- Complaint Handling – Manages complaints from investigation to resolution with actionable insights.
Top QMS Platforms for Businesses
Here’s a look at some of the leading QMS solutions available, tailored to different industries and business needs.
1. TrackWise Digital
TrackWise Digital is a leading cloud-based Quality Management System (QMS) designed to streamline quality processes, enhance compliance, and support data-driven decision-making. Equipped with AI-powered capabilities like auto-summarization and auto-categorization, it helps organizations boost productivity and operational efficiency in quality management.
With advanced analytics and real-time reporting, TrackWise Digital enables users to leverage quality data, fostering a strong culture of quality and driving company-wide performance improvements.
TrackWise software helps in Deviation filing, Tracking of CAPAs, reporting and assessment of Product Quality complaints, raising change control procedures. It is very difficult to use excelsheet and track all these activities. A software helps in proper control and timely alerts. For Corporate Quality Assurance in Pharma company its a very important tool. TrackWise is developed by Sparta systems.
Ideal for: Pharma companies requiring robust tools for deviation management, CAPA, and product quality complaints.
2. MasterControl
Tailored for the life sciences industry, MasterControl offers document control, training program management, CAPA, and supplier management tools. It’s designed to ensure compliance with FDA, ISO, and GxP regulations, making it incredibly versatile for highly regulated industries.
Ideal for: Businesses looking for a compliance-first solution with full automation capabilities.
3. Veeva Vault QMS
Veeva’s cloud-based platform simplifies audit trails, regulatory compliance tracking, and training management. Its intuitive interface and streamlined processes minimise risk and improve operational transparency.
Ideal for: Pharmaceutical and biotech companies operating under strict industry guidelines.
4. ETQ
ETQ offers a flexible solution with tools for document management, risk assessments, and training compliance. Its AI-driven analytics enhance decision-making by providing actionable insights on quality processes.
Ideal for: Companies looking for strong AI capabilities to aid decision-making.
5. Intelex
Intelex stands out with features like incident tracking, regulatory compliance monitoring, and automated workflows. Its user-friendly dashboards and AI-powered insights streamline quality and risk management efforts.
Ideal for: Mid-sized businesses aiming to optimise compliance and risk management.
6. AssurX
With its scalable and customisable capabilities, AssurX simplifies nonconformance tracking, CAPA, audits, and supplier management. The platform ensures adherence to FDA, ISO, and GMP guidelines.
Ideal for: Businesses ready to scale their quality management processes.
7. Qualityze
Qualityze, built on Salesforce, offers document control, supplier audits, and risk assessment features. Its user-friendly interface supports seamless integration and enhanced collaboration.
Ideal for: Teams looking for a Salesforce-based solution with AI-supported functionality.
8. Greenlight Guru
Greenlight Guru caters specifically to medical device and pharma companies, helping them meet regulatory standards like FDA and EU MDR while focusing on product development.
Ideal for: Start-ups aiming to simplify compliance and streamline product development.
Other Considerable Pharma QMS Software
- Pilgrim SmartSolve – Focuses on regulatory compliance and audit management with automated features.
- SAP – Integrates QMS with broader ERP tools, supporting quality tracking alongside other business operations.
- Plex Systems – Combines QMS with real-time manufacturing oversight, ensuring seamless batch tracking.
- Ideagen – Offers extensive risk management and audit readiness for highly regulated industries.
Key Considerations When Selecting a QMS
Every organisation has unique needs, which means no single QMS solution will fit all businesses equally. Consider these factors while making your choice:
1. Industry-Specific Requirements
Are you in a highly regulated industry like pharmaceuticals or medical devices? Look for tools like MasterControl or Veeva that cater specifically to compliance-heavy industries.
2. Scalability
Is your business growing quickly? Platforms such as AssurX and ETQ offer scalable solutions that can adapt to your evolving needs.
3. Integration
Does the QMS need to integrate with your existing software stack? Solutions like Qualityze on Salesforce or SAP’s ERP-integrated QMS might be ideal.
4. Budget and Resources
Solutions like Intelex and Greenlight Guru are highly valuable tools but may require significant upfront investments. Consider your budget without sacrificing essential functionality.
5. Key Features
Focus on tools that align with your needs, whether that’s CAPA workflows, deviation management, or advanced analytics for decision-making.
These are validated software and audit trail of each activity can be reviewed. Depending on the budget and requirements of department, these Pharmaceutical QMS software can be considered