Top 7 eQMS Solutions for Clinical Trials

eQMS software for quality management in clinical trials

A clinical trial is already a lengthy, complex process that takes several years to complete as it goes through numerous phases, including initial study designs, IRB approvals, participant recruitment, and final data assessments.

If there are problems due to ineffective quality control at any clinical trial stage, operations can be halted in their tracks, leading to further delays that cost a drug development endeavor time, resources, and money.

However, with a quality management system (QMS), sponsors and CROs can mitigate the risk of quality issues before they arise, streamlining clinical trial operations from start to finish.

Many other sectors in health sciences, such as healthcare institutions, pharmaceuticals, biotech firms, and medical device manufacturers, have already adopted QMS or eQMS software with much success.

Therefore it stands to reason clinical trial stakeholders can find similar success from utilizing an eQMS solution not only to optimize processes and avoid delays but also to uphold regulatory standards critical for furthering drug development.[1]

In clinical studies, a quality management system typically helps manage a variety of complex documentation, such as trial protocols, participant information, audits, and guidelines.

However, QMSs vary, offering different features and facilities, and not all benefit every clinical trial. For example, a standard QMS will deal with paper-based records and documents that are easier to understand and manage but prone to human error. Furthermore, sponsors and CROs may struggle with paper-based QMS solutions as it is harder to maintain transparency and traceability. Additionally, there are issues with access, loss of documents, storage, auditing, and lengthy authoring process.[2]

On the other hand, an eQMS (electronic quality management system) takes away the hassle and headache of outdated paper-based systems by providing a digital solution via software to facilitate quality management.[2] With an eQMS, teams can easily share, review, and track their documentation in real-time as the trial progresses. Furthermore, sponsors can oversee operations to ensure all regulatory compliance guidelines are followed as necessary.[3]

With automated checks and electronic signatures, electronic quality management systems maintain the integrity and consistency of a clinical trial, keeping trial site staff accountable. Additionally, it is less prone to human error and allows for better communication and transparency [2],[3]

Other advantages of electronic quality management systems include the following:

  • Increases efficiency and reduces overall operating costs
  • Assist compliance with standard regulations and guidelines, such as ISO 13485:2016, FDA 21 CFR Part 820, ICH Q10, etc.
  • Help meet customer requirements by designing products and protocols that are safe, effective, and meet regulatory standards.
  • Automate manual processes such as managing and tracking workflows, documents, and data.
  • Simplify the informed consent process through electronic signatures.
  • Generate automated reports that highlight trends and pinpoint areas that require improvement.[4]

It is important to note that eQMS also stands for enterprise quality management system, a broader term used by large pharma companies that sponsor multiple clinical trials. Electronic QMSs play a small role in an enterprise system.[4]

What to look for in an eQMS software solution

Organizations with multiple documentation types, spreadsheets, and other software programs to manage operations can benefit from eQMS software. Additionally, a lack of communication, repeated human errors, and the inability to comply with regulatory standards also indicate the need for an eQMS software solution in a clinical trial.

Given the number of solutions available, it is important to understand which ones fulfill your requirements and have the quality management features to supplement your research work. Thus, we have compiled a list of must-have features you must look for before investing in an eQMS for your clinical trials.

  • Built-In Regulatory Compliance – Regulatory guidelines and standards are known to grow in number and complexity, making it tedious to keep track of them as they are updated. An eQMS software with built-in compliance is pre-configured from the start, allowing you to store and share information in a single location accessible to auditors and the quality team. Moreover, solutions that comply with FDA 21 CFR Part 11 provide patients with remote consent and re-consent facilities that remove the problems associated with commuting and travel restrictions.[4],[5]
  • Risk Management - An eQMS that also covers risk management provides a safety net to catch the human errors that are known to plague paper-based quality management systems.[5]
  • Deployment method- how an eQMS is deployed given a trial site’s current system is another crucial aspect sponsors need to consider. For instance, is a cloud-based or non-cloud-based system more suitable for your study needs? While a cloud-based system is easier to manage and doesn’t require additional equipment, it may be susceptible to unverified access. On the other hand, a non-cloud-based eQMS is more secure but requires special hardware and staff to manage and keep it up-to-date with the latest technology.[4]
  • Pre-Validated - an eQMS with pre-validation ensures your system and software comply with the FDA requirements. Moreover, pre-validated eQMS software saves money and resources as a developer has already undergone the time-consuming validation process.
  • Statistical Process Control (SPC) - eQMS software with SPC provides advanced data-modeling tools to measure and control underutilized resources. Additionally, SPC helps organizations make intelligent decisions backed by data regarding process control and equipment issues.[5]

Top 7 eQMS software solutions for clinical trials

Investing in quality eQMS software can improve drug development efforts by ensuring patient safety and maintaining quality and compliance with regulatory boards. Furthermore, it gives you a holistic overview of your clinical trial, allowing teams to stay true to the organization’s objectives.[1]

However, it can be challenging to find an eQMS solution that fits your requirements and satisfy the following considerations:

  • Does the QMS integrate easily with other software, such as data captured from EDCs, eTMF, and CTMS?
  • Is it compliant with standards such as ICH Good Clinical Practice (GCP) and ISO 14155:2020?
  • Is the vendor reliable?
  • Do they offer all integrated systems or just EQM software?

Therefore, to assist in your research, we have compiled a list of seven of the best eQMS software currently available, based on popularity and market share in no particular order.

IQVIA SmartSolve® eQMS

The winner of the 2023 Frost & Sullivan award for best QMS platform for the life sciences industry in North America, the SmartSolve® eQMS is IQVIA’s next-generation quality management software.

IQVIA is an industry leader with over one million customers using its enterprise-level quality management systems for good reason. Its systems reduce repetitive tasks and enable you to produce safe, effective products through enhanced trial quality and faster regulatory approvals, all made possible with a highly integrated platform for process automation and simplified global control.

Moreover, SmartSolve® also fits seamlessly with IQVIA’s SmartSolve™ Regulatory Connector to enhance accuracy, efficiency, compliance response time, and predictive planning.

This eQMS may be ideal for sponsors or CROs looking for a comprehensive solution with multiple features to streamline operations across the clinical trial.


MasterControl is an all-in-one digital quality management system that promotes collaboration, accelerates product production, speeds up market launches, and improves decision-making.

Used by hundreds of companies worldwide, it is well known for its digitization abilities uploading paper-based data and documentation to its Cloud, enhancing compliance and quality via continuous updates. Additionally, its end-to-end solution automates and simplifies training and quality audit management.

This cloud-based eQMS solution complies with FDA regulations and ISO quality standards to become the ideal software for optimized workflow and integrating multiple processes, such as data collection, personnel permission, and more.

This system may be ideal for sponsors or CROs looking for an end-to-end cloud QMS system that can turn paper-based documents into digital forms, eliminating manual tasks.

Agatha Quality

Agatha Quality is a ready-to-use quality management system focused on key forms needed for life sciences GMP environments and ClinOps. It is a great tool for quality managers, simplifying document management and workflows.

This eQMS is pre-configured and pre-validated, fully compliant with 21 CFR Part 11 and EU regulatory requirements. Additionally, it is flexible enough to adjust to specific process requirements by providing advanced forms that can be modified with additional text fields, images, and formatted text.

Furthermore, its user-intuitive dashboard enables users to generate custom reports and export them to Excel or a CSV format conveniently, and it seamlessly integrates with other Agatha applications, such as CAPAs.

This eQMS may be ideal for sponsors or CROs looking for a ready-to-use, user-intuitive quality management system with no complicated deployment process and customizable forms, reports, and audit trails.


Rated the top-ranked easy-to-use eQMS software in over 80 countries, Qualio is a purpose-built holistic quality management system trusted by biotechs, pharmaceuticals, medical device manufacturers, and CSP companies worldwide.

With its open design control management, this eQMS can integrate with multiple systems, like Jira, Azure DevOps, and TestRail, centralizing control data for easy real-time document sharing.

Furthermore, Qualio complies with ISO 14971 and ICH Q9 standards, facilitating risk detection and mitigation. Also, it can be used to improve supply chain management by setting policies, enforcing document requirements, and regulating audit frequencies.

Qualio may be ideal for sponsors and CROs looking for purpose-built eQMS software that manages clinical trials from start to finish via an easy-to-build dashboard for risk control, supplier management, change management, and design control.

Solabs eQMS

Solabs eQMS (Enterprise-Quality Management Software) offers all the necessary features to simplify data, manage documentation, and achieve clinical trial objectives. Users can create, review, approve, and remove documents with all changes recorded through e-signatures and timestamps.

Solabs essential package also includes advanced reporting capabilities that enable you to create, share, and customize reports in multiple formats. Additionally, using the SOLABS QM10 Audit APP, you can track internal and external documents while managing audit planning, preparation, and closure.

Moreover, its training section offers a secure, validated system where you can schedule and monitor training that is compliant with regulatory standards across all departments

This solution is available in two interfaces; one with Office 365 for collaborative document review and another that supports Microsoft Azure AD and OneLogin as SSO providers.

This eQMS may be ideal for sponsors and CROs looking for an enterprise quality management system that is easy to implement and use while offering project management, validation, configuration, and technical support.


QUMAS EQMS is a cloud-based enterprise quality and process management system that helps organizations improve information collection, tracking, and analysis through a validated compliance management system.

You can create, review, approve, and manage multiple pre-configured quality processes, such as deviations, complaints, audits, and CAPAs. All operations are handled via a user-friendly interface called MyQUMAS.

This dashboard also generates automated reports that can be printed, emailed, and scheduled. Furthermore, this solution offers multiple quality control activities, such as CAPA management, a facility that captures, records, routes, and verifies completion and approvals. It also audits each step in the CAPA process and uses a closed-loop approach for automated data entry.

This system may be ideal for sponsors or CROs looking for an enterprise quality and process management system with a user-friendly interface to manage multiple quality control processes, such as risk management, CAPA management, and regulatory compliance.

Bonus: Transcelerate Biopharma QMS Initiative

Guidance for creating your own QMS

Transcelerate is not selling eQMS software. Rather, it has developed a quality management system (QMS) initiative that allows organizations to improve their compliance with regulatory standards and operational workflows by increasing the awareness of the benefits of using quality management software for life sciences.

Furthermore, emphasizes the importance of an industry-wide conceptual framework for clinical quality management that evaluates and measures regulatory authorities, increases patient safety, and resolves repetitive quality issues.

This solution may be ideal for sponsors or CROs developing a conceptual framework for managing operations according to industry-specific needs and requirements.


Every clinical trial is burdened by an excess of documentation, planning, scheduling, and managing multiple operational workflows that become increasingly overwhelming as the complexities of a study increase.

While quality managers are responsible for generating, tracking, and analyzing all workflows and reports to ensure the trial’s objectives are met, it can be bogged by human errors when these tasks are handled manually. And these Substantial errors can lead to costly delays.

However, with eQMS software, all these manual, error-prone tasks can be digitalized and automated, making it easier to maintain quality and compliance.

Having said that, it is important to understand the requirements of your trial site and study to ensure you have the right electronic quality management system handling operations.

Therefore, it is vital to ensure a potential eQMS has all the features you need and is easily integrated with other existing data management systems while remaining within budget.