Illustration of an Electronic Quality Management System

eQMS Software (Electronic Quality Management System)

by | May 1, 2024 | QMS

An eQMS is an Electronic Quality Management System that helps companies automate and streamline their quality management processes.

Companies use eQMS primarily to streamline processes, ensure regulatory compliance, and improve overall quality management across their operations.

The eQMS software supports quality teams in managing and tracking quality management-related processes, such as document control, change management, training management, supplier management, and many others, in a centralized and efficient manner.

Companies utilizing eQMS benefit from improved customer and regulatory compliance, streamlined processes, and increased efficiency.

When choosing an eQMS, companies should first assess the specific requirements applicable to them, thoroughly research and compare QMS software vendors, participating in demo meetings. Companies must ensure that the QMS software aligns with the company’s needs and objectives.

This article discusses what an eQMS stands for, what is included in an eQMS, why companies adopt eQMS, its functions, and its benefits. Additionally, the article briefly explains how to choose the right eQMS solution, offering key considerations, and provides examples of the best QMS software for Life Sciences.

SimplerQMS offers a fully GAMP 5-validated eQMS software designed specifically for Life Science companies. Book a demo to see how our solution streamlines quality management processes and helps ensure compliance.

Explore the specific topics covered in this article:

What is an eQMS?

An electronic Quality Management System (eQMS) is a digital platform designed to centralize, automate, and streamline quality-related processes within a company. The eQMS encompasses features such as document control, change management, training management, Corrective and Preventive Actions (CAPA), risk management, audits management, and others.

An eQMS is the digital format of a quality management system, offering a modern approach to managing quality management processes. Other formats of QMS include traditional paper-based QMS relying on physical documentation and hybrid systems that combine digital and paper-based formats of quality management.

Companies facing challenges with paper-based and hybrid QMS, like lost documents, outdated records, and inefficient processes, can benefit from implementing an eQMS. An eQMS aids companies in overcoming paper-based and hybrid system challenges by automating quality management processes and simplifying the tracking and management of data, documents, and workflows.

Typically, an eQMS is deployed as a cloud-based quality management system. The cloud-based nature of eQMS makes it accessible to authorized users anywhere, at any time, and on authorized devices with an internet connection.

While cloud-based eQMS are popular solutions, an on-premise option also exists, allowing companies to host the system’s infrastructure in a way that best fits their needs and preferences.

Electronic QMS supports companies in achieving and maintaining regulatory compliance. It enables companies to monitor compliance with industry regulations, standards, and guidelines and proactively identify and address issues.

What is the Difference Between Electronic QMS (eQMS) and Enterprise QMS (EQMS)?

While eQMS stands for Electronic Quality Management System, the term can occasionally be associated with Enterprise Quality Management System (EQMS).

Electronic Quality Management System (eQMS) refers to a digital platform designed to automate and streamline quality management processes.              

Enterprise Quality Management System (EQMS) is the quality management software large enterprise-size companies utilize to manage their quality management processes. Many larger companies and enterprises have adopted eQMS as their quality system due to the difficulties of maintaining a manual QMS at scale.

Enterprises can utilize one or more eQMS software solutions depending on their needs. Enterprises utilize specific functionalities within the eQMS, such as site functions, which enable organizations to restrict access to specific documents based on user roles assigned to individual sites.

SimplerQMS provides broad QMS process support and scalability, being an Enterprise Quality Management System provider. SimplerQMS eQMS software offers the ability to manage different sites. Each site can access documents specific to them while following the same predefined workflows across the organization.

Why Do Companies Use an eQMS System?

Companies use an eQMS system to streamline quality management processes, reduce costs, increase efficiency, and help ensure regulatory compliance.

Implementing an eQMS is beneficial for companies that need to comply with comprehensive customer and regulatory requirements. For instance, eQMS benefits companies in the Life Science industry, such as pharmaceutical, biotechnology, and medical devices. The eQMS provides support for QMS processes to ensure continuous improvement and compliance with requirements.

Life Science companies must comply with regulations, standards, and guidelines that outline the requirements for the Quality Management System (QMS).

What Does eQMS Software Do?

The electronic QMS software automates and streamlines the handling of documents, policies, procedures, and processes essential for ensuring product safety and effectiveness. The eQMS software provides a centralized repository for all documents and data, making it easy to manage quality processes and workflows.

Electronic QMS streamlines quality processes and facilitates compliance with requirements by offering features like document control, change management, training management, audit management, supplier management, and many more. The eQMS enhances operational efficiency, improves efficiency, increases collaboration among team members, and helps ensure compliance.

A suitable eQMS should seamlessly integrate with a company’s existing operations, ensuring a harmonious alignment with established quality management processes.

An effective eQMS should optimize quality management processes by enabling companies to:

  • Efficiently create, modify, review, approve, and retire documents.
  • Securely approve documents using electronic signatures.
  • Manage document versions and control access based on user roles and permissions.
  • Monitor and handle quality events like nonconformances, customer complaints, audit findings, and CAPAs.
  • Simplify and guide through various quality management processes, including employee training management, change control, design control, risk management, equipment calibration, supplier management, and more.
  • Generate reports and analyze quality data to recognize trends and areas for ongoing improvement.
  • Strategically plan, schedule, execute, and document quality audits.
  • Assist in maintaining compliance with applicable requirements.

What Are The Benefits of eQMS Software?

The benefits of implementing QMS software include the following.

  • Improved Compliance: eQMS software helps ensure that companies comply with customer and regulatory requirements. The software’s predefined workflows guide users through the correct process steps. All actions are automatically documented in a time-stamped audit trail.
  • Improved Process Efficiency: By streamlining workflows and automating repetitive tasks, eQMS software improves process efficiency, reducing the need for manual work.
  • Improved Product Quality: eQMS software helps enforce consistent execution of quality procedures throughout predefined workflows. Electronic QMS helps achieve higher and more uniform product quality and fewer deviations and nonconformances.
  • Enhanced Communication: The eQMS software fosters collaboration and communication among team members. The software provides a centralized platform for sharing information, feedback, and updates.
  • Cost Reduction: By reducing quality issues and streamlining processes, eQMS platform helps lower operational costs. eQMS also enables companies to optimize resource allocation with data-driven decision-making.
  • Audit Readiness: eQMS software maintains accurate and up-to-date histories of quality-related activities, making companies well-prepared for audits and inspections. The eQMS facilitates access to documentation, document retrieval, evidence of compliance, and traceability, ensuring smooth audit processes.
  • Data-Driven Decision-Making: The eQMS software provides quality data, and KPI reports that allow companies to identify quality performance, trends, and areas for improvement. eQMS software enables companies to make informed decisions based on quality data, driving continuous improvement and strategic planning.

What Makes a Good eQMS Software?

Below are the key factors contributing to good eQMS software.

  • QMS Process Support: The software offers comprehensive support for all quality management processes.
  • Computer System Validation (CSV): Fully validated eQMS software ensures compliance with requirements regarding computer system validation.
  • Regulatory Compliance: Good QMS software supports compliance with industry-specific requirements.
  • Flexible Implementation Process: A flexible implementation process enables companies to tailor the software implementation to their specific needs.

Additional details on each factor contributing to a good eQMS software are presented below.

QMS Process Support

The QMS software provides comprehensive support for all quality management processes.

A good QMS software supports processes such as:

  • Document Control
  • Change Control
  • Training Management
  • Supplier Management
  • Design Control
  • Risk Management
  • Audit Management
  • Nonconformance and Deviation Management
  • CAPA Management
  • And more.

Computer System Validation (CSV)

Fully validated eQMS software ensures compliance with regulatory requirements, safeguards data integrity, and helps maintain product quality and safety.

Computer System Validation (CSV) is the process used to ensure a computerized system meets its intended use consistently. Validation of quality management system software is a requirement when the software is used to manage regulated processes.

The validation of QMS software involves three key stages: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These protocols ensure that the software is correctly installed, functions as intended, and performs effectively in real-world scenarios.

SimplerQMS offers a fully validated eQMS solution in accordance with ISPE GAMP 5. The software remains in a validated state at all times, with SimplerQMS managing all validation and revalidation tasks.

Regulatory Compliance

QMS software supports compliance with regulations, guidelines, and standards that outline QMS requirements applicable to companies operating in specific industries, such as the Life Science industries. Good QMS software facilitates quality processes to ensure adherence to regulatory requirements.

For example, for pharmaceutical companies, specific requirements include compliance with guidelines for pharmaceutical quality systems like ICH Q10 and Good Manufacturing Practices (GMP) regulations such as FDA 21 CFR Part 211.

In the medical device industry, requirements encompass standards for quality management systems, such as ISO 13485:2016, current Good Manufacturing Practices (cGMP) like FDA 21 CFR Part 820, as European regulations such as Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Additionally, common QMS requirements can apply to several industries, including the general quality management systems standard ISO 9001:2015. Other requirements QMS software solutions often comply with include the cybersecurity standard ISO 27001:2022 and the regulation for electronic signatures and records, such as FDA 21 CFR Part 11, as well as requirements for using computerized systems EU Annex 11.

eQMS Compliance for Pharmaceuticals and Medical Devices

Compliance With FDA 21 CFR Part 11

The QMS software that is compliant with the 21 CFR Part 11 regulation follows a comprehensive framework for managing electronic records and signatures in a secure and compliant system.

The United States Food and Drug Administration (FDA) 21 CFR Part 11 is a regulation that aims to ensure electronic records and electronic signatures’ integrity, reliability, and authenticity.

SimplerQMS offers 21 CFR Part 11-compliant eQMS software specifically designed for Life Science companies. The eQMS software includes controls for electronic signatures and records, including management of passwords and identification codes, automatic linking of signatures to records, and comprehensive audit trails, among many other functionalities.

Compliance With EU Annex 11

By complying with EU Annex 11, an eQMS demonstrates its reliability, security, and integrity in managing electronic records and signatures. The eQMS effectively safeguards data, maintains audit trails, and upholds the authenticity of electronic documentation.

The EU Annex 11 is the European Union guideline establishing the requirements for computerized systems within GMP-regulated activities. EU Annex 11 includes requirements for electronic records and electronic signatures.

SimplerQMS provides eQMS software designed for Life Science companies and complies with EU Annex 11. The eQMS complies with computerized system requirements, including system validation, generation of audit trails, appropriate personnel training, secure data storage, records retrieval, and security measures.

Flexible Implementation Process

A good eQMS software is characterized by a flexible implementation process, which empowers companies to tailor the software implementation according to their specific needs and timelines.

A flexible implementation process allows companies to customize the implementation phases by prioritizing the implementation of certain QMS modules and accommodating upcoming audits or inspection deadlines.

For example, some companies need to fast-track implementation for upcoming audits, while others prefer a longer implementation period.

Companies focused on manufacturing may prioritize implementing Equipment or Suppliers Management modules, while companies dealing with recorded issues prioritize implementing the CAPA (Corrective and Preventive Actions) Management module.

SimplerQMS’s Customer Success team collaborates with customers in kick-off meetings to outline a personalized plan for QMS software implementation. SimplerQMS offers a phased implementation process. Each phase focuses on implementing and providing training for specific QMS modules, which can be customized to the needs of each customer.

How to Choose an eQMS Software?

Choosing an eQMS software involves several steps to ensure that the selected solution aligns with the company’s needs and objectives.

The steps companies can follow to choose an eQMS software are mentioned below.

  1. Assess Your Requirements: Identify all relevant regulations, standards, and guidelines the company needs to comply with. Outline the functionalities the QMS software needs to have to comply with the applicable requirements.
  2. Research and Compare QMS Software Vendors: Gather information about vendors and their solutions through Requests for Information (RFI), Requests for Quotation (RFQ), and Requests for Proposal (RFP). Compare the chosen QMS software and vendor features side-by-side.
  3. Select Relevant QMS Software Vendors:  Based on information from RFI, RFQ, and RFP, choose vendors that best align with the company’s needs. Consider vendor reputation and customer reviews.
  4. Get Demos and Have Meetings: Request demos from shortlisted vendors to see how the software operates and assess its suitability. Schedule follow-up meetings to explore specific QMS modules and clarify doubts.
  5. Consider Getting a Trial:  Request a trial period to evaluate the software’s functionality, usability, and compatibility with existing workflows.
  6. Shortlist QMS Software Vendors:  Narrow down the QMS software options based on the information gathered from demos, meetings, and trials.
  7. Get Demonstration of Specific Use Cases:  Request demonstrations tailored to address specific use cases and scenarios, ensuring the software addresses daily operations.
  8. Negotiate With Shortlisted QMS Providers: Negotiate with shortlisted vendors for favorable terms regarding pricing, contract terms, implementation timelines, and any additional needs.
  9. Make Final Decision:  Carefully consider all information, including demos, trials, and negotiations, to choose the QMS software that best aligns with the company’s needs and offers the most comprehensive solution.

Simplify your decision-making process by downloading our complimentary QMS Software Comparison Template.

Utilize the template to perform a comprehensive side-by-side comparison of different QMS software solutions, assessing vendor features, functionalities, and pricing structures tailored to your specific requirements.

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What Are the Key Considerations When Choosing an eQMS Software?

Below are some considerations for selecting the right QMS software.

Be aware that choosing QMS software involves a comprehensive series of steps and considerations to ensure the final decision aligns with the company’s needs and objectives.

  • Quality Management System Needs: Clearly outline the company’s quality management system needs. Identify specific quality processes, compliance requirements, and features an eQMS must address.
  • Training and Support: Consider the training options and support provided by an eQMS vendor. Adequate training ensures that users can maximize the system’s capabilities, while reliable support is essential for addressing any issues.
  • Validation and Certification: Look for eQMS software that has undergone validation processes and follows the Good Automated Manufacturing Practice (GAMP), such as ISPE GAMP 5.
  • Additional Features: Evaluate the supporting technology offered by the QMS. Supporting technology may include real-time data dashboards, mobile accessibility, a document editing interface, integration possibilities, and reporting solutions.
  • Cloud-Based Deployment: Consider opting for a cloud-based eQMS. Cloud solutions offer accessibility, flexibility, and often include regular updates without requiring extensive on-premise infrastructure.

When Is the Right Time to Consider an eQMS?

Life Science companies often consider implementing an eQMS once they have established or are actively developing their quality management system and associated documentation.

Determining the precise moment to implement a QMS software is complex.

The five main reasons to consider an eQMS are listed below.

  • Improving communication across departments
  • Automating QMS processes
  • Improving compliance efforts
  • Gaining better visibility into quality data
  • Seeking scalability

While finding the ideal time is challenging, companies gain greater benefits by implementing an eQMS sooner rather than later. Early adoption of QMS software allows companies to build a robust foundation for ensuring quality and compliance.

Illustration of a woman sitting next to an eQMS clock

How Much Time Does It Take to Implement QMS Software?

The comprehensive QMS software solution is typically implemented within a timeframe of 5 to 6 weeks.

The duration of QMS software implementation may vary based on factors such as the number of documents requiring creation or migration, as well as the availability of time resources within the company.

For example, SimplerQMS software implementation follows a structured phase approach that focuses on deploying distinct QMS modules. The SimplerQMS implementation allows for customizable QMS module sequences based on individual requirements, with all implementation activities and associated training provided at no extra charge.

How Much Does an eQMS Cost?

The cost of the software may vary depending on factors such as the number of QMS modules, licenses, and add-ons like implementation and training, among others.

For instance, QMS software prices usually start at $13,000 for a company with 5 to 10 employees. The price range for QMS software can vary from $25,000 to $100,000 for companies with 50 to 200 employees.

SimplerQMS provides an all-inclusive solution that includes all QMS modules, system implementation, user training, ongoing support, validation, and cloud hosting within the yearly license cost.

The pricing structure of SimplerQMS is determined by the number of licenses acquired. The license price covers all features and services, eliminating the need for additional costs.

Visit our pricing page for detailed information regarding costs and the features and services provided.

The 9 Best QMS Software Solutions for Life Sciences

The 9 best QMS software solutions for Life Sciences are listed below. The best QMS software solution for the Life Sciences list results from the expertise of our quality specialists, feedback from customers and partners, and extensive research.

1. SimplerQMS

SimplerQMS is a cloud-based quality management system (QMS) software specifically designed for companies in the Life Sciences industry. SimplerQMS offers comprehensive support for all QMS processes, including document control, training management, change management, non-conformance and deviation management, CAPA management, design control, audit management, equipment management, and more.

SimplerQMS software seamlessly integrates with the Microsoft suite, allowing for easy document editing and collaboration using familiar tools such as Word, Excel, and PowerPoint.

The software is fully validated according to GAMP 5. SimplerQMS helps companies comply with various regulatory requirements related to Life Sciences, such as GxP, ISO 13485:2016, 21 CFR Part 11, EU Annex 11, and others.

SimplerQMS is available as an all-inclusive annual subscription with pricing based on the number of user licenses. The subscription includes all QMS modules, system implementation, training, validation, hosting, and support. Users appreciate the software’s ease of use and good value for the price, and customer support is often praised for its expertise and responsiveness.

2. Qualio

Qualio offers a cloud-based quality management platform specifically designed for growing Life Science companies in medical devices, pharmaceuticals, and biotechnology.

The software provides core QMS functionalities like document management, risk management, and training. Qualio helps ensure compliance with requirements such as FDA 21 CFR Part 11, ICH Q10, GxP, ISO 13485:2016, and more. While pre-validated according to GAMP 5, some additional customer-side validation is required.

Qualio is known for its ease of use, efficient implementation process, and helpful customer support. It integrates with various popular apps but lacks integration with Microsoft Office. Pricing is tiered based on features and user licenses.

3. MasterControl

MasterControl offers QMS solution catering to various industries, including pharmaceuticals, medical devices, and food and beverage. Primarily targeted at large enterprises, MasterControl manages core quality processes like document control, training, and nonconformance management, among others.

MasterControl software is FDA 21 CFR Part 11 compliant and supports various requirements, such as FDA regulations, ISO requirements, CLIA, EU MDR, and more.  The software automates GAMP 5 processes and offers a patented Validation Excellence Tool (VxT) for user-friendly software validation. 

MasterControl is known for its robust document management features and easy integration with other software applications, such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Manufacturing Execution Systems (MES), and more. Pricing is tiered based on features, users, and additional services.

4. TrackWise

TrackWise offers both on-premise (TrackWise) and cloud-based (TrackWise Digital) QMS solutions with AI-powered features for proactive quality management.

The software caters to various industries, including pharmaceuticals, medical devices, and food and beverage. TrackWise centralizes all QMS processes for improved efficiency, compliance, and risk reduction. 

TrackWise supports Life Science requirements, such as FDA 21 CFR Part 11, 211, and 820, EU Annex 11, MDR, ICH Q9, Q10, and Q11, GxP, and ISO standards. The software provides a computer system validation package for each software release.

Pricing is customized based on user needs and requires contacting sales for a quote. Users appreciate the high level of configurability and integration with other business systems like Salesforce.

5. Ideagen Quality Management

Ideagen Quality Management is a modular eQMS solution catering to diverse industries like life sciences, manufacturing, and healthcare.

Ideagen offers a comprehensive suite of QMS modules like document control, audit management, CAPA, and others, all integrated and streamlined with automated workflows. The software uses familiar tools like Microsoft Office for document editing.

Ideagen, in collaboration with CompliancePath, provides end-to-end validation services. While basic validation is included, full validation requires additional investment.

User praise focuses on the system’s document control, CAPA management features, and exceptional customer support. Pricing remains undisclosed but can be purchased as a perpetual license or subscription.

6. Greenlight Guru

Greenlight Guru is a cloud-based QMS platform designed specifically for the MedTech industry. Greenlight Guru offers comprehensive QMS modules, including document management, training, and risk management, among others, alongside specialized features for design control and clinical trials.

Greenlight Guru stands out for its ease of use and risk-based computer system validation package, aligning with FDA regulations and best practices. Users benefit from in-app document editing and a native traceability matrix generation tool.

The software offers tiered subscription plans with dedicated support and on-demand training resources. Medical device industry experts guide implementation, and it can be completed within 2-8 weeks.

Greenlight Guru is praised for its intuitive interface and well-structured workflows, particularly for design control and risk management, making it a strong choice for MedTech companies.

7. Dot Compliance

Dot Compliance offers a pre-configured, cloud-based QMS built on the Salesforce platform. Dot Compliance software provides features like interconnected QMS modules, facilitating management across various quality processes. The software offers an AI assistant for data insights.

Dot Compliance allows for document management with Microsoft Office integration, keeping document editing in familiar applications.

The software supports compliance with FDA regulations, GMP, EU MDR, ISO 9001:2015, 13485:2016, 14791:2019, 27001:2022, and more. Dot Compliance helps ensure GAMP 5 compliance with a fully executed validation package.

Dot Compliance offers tiered pricing with various features and modules depending on the chosen plan, making it a scalable solution for growing Life Science companies.

8. QT9

QT9 offers a cloud-based quality management system that attends companies of all sizes across various industries, including Life Sciences, manufacturing, and food and beverage.

The software offers over 23 built-in QMS modules, including document control, risk management, and training. QT9 supports compliance with various requirements like FDA regulations and ISO standards. The software provides free validation reports (IQ, OQ, PQ) with every update.

QT9 is known for its scalability with a modular pricing structure, unlimited training options, and a free 30-day trial. Customers also appreciate its user-friendly interface and strong integration with their existing technology, especially with its own ERP system.

9. Scilife

Scilife offers a cloud-based quality management platform designed to streamline quality management processes and empower Life Science companies. Scilife provides core QMS modules such as document management, training, CAPA, and others. The software seamlessly integrates Microsoft Office for document editing.

Scilife is validated according to GAMP 5 on the Amazon Web Services (AWS) platform, taking care of most user validation tasks. Scalable pricing with a free plan and tiered options allows companies of all sizes to benefit. Users praise Scilife’s affordability, ease of use, and excellent customer support.

Learn More About SimplerQMS Today

Now that you know all about what eQMS is and some of the best Life Science eQMS software on the market, it is time to evaluate which one is right for your Life Science company.

Let’s take the next step in streamlining your quality management journey today.

You can book a demo with one of our Quality Solution Consultants to discover how SimplerQMS can benefit your company.

eQMS Software Comparison Template

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