Electronic Quality Management System (eQMS)

An electronic Quality Management System or eQMS is a digital platform designed to centralize, automate, and streamline quality management processes within an organization.

By transitioning from traditional paper-based systems to electronic solutions, eQMS streamlines quality management by digitizing documentation, automating workflows, and enhancing traceability and compliance. Electronic QMS enhances compliance, efficiency, and decision-making by automating workflows and minimizing manual errors.

Organizations implement a QMS to meet customer and regulatory requirements. An eQMS streamlines compliance with requirements like FDA 21 CFR Part 830, ISO 13485, ISO 9001, and others, through predefined workflows, automated reminders, enhanced collaboration, and real-time reporting.

The main benefits of an eQMS include improved compliance, as workflows guide users through processes, reducing the risk of errors. eQMS enhances process efficiency by automating tasks and eliminating manual paperwork. The software fosters better collaboration and communication, reduces operational costs, and supports data-driven decision-making with real-time analytics and reporting tools. Additionally, an eQMS ensures audit readiness by offering a time-stamped audit trail and document versioning.

Selecting an eQMS requires assessing regulatory needs and business objectives, researching providers, comparing options, and shortlisting suitable solutions. Companies looking for an eQMS should request demos and trials to evaluate usability and integration capabilities, among other aspects before deciding which eQMS system aligns with long-term goals.

SimplerQMS is among the leading eQMS providers for companies in the life science industry. SimplerQMS offers fully validated, cloud-based eQMS software tailored for regulated life science industries such as pharmaceuticals, medical devices, and biotechnology. SimplerQMS supports all QMS processes, integrates with Microsoft Office, and supports compliance with QMS requirements such as FDA 21 CFR Part 830, ISO 13485, ISO 9001, GxPs, and other requirements.

SimplerQMS provides an all-inclusive subscription covering eQMS software implementation, unlimited training, validation, and ongoing customer support, among other things.

To streamline quality management processes and ensure compliance, book a demo with SimplerQMS to explore its capabilities and suitability for your needs.

What is an Electronic Quality Management System (eQMS)?

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

An eQMS is a digital quality management system that offers a modern and more streamlined approach to managing quality management processes. Other formats of QMS include traditional paper-based QMS that rely on physical documentation and hybrid systems that combine digital and paper-based formats.

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.

Nowadays, an eQMS is deployed as cloud-based quality management software. Cloud-based quality management software is hosted on remote cloud servers and accessed via the Internet, enabling real-time collaboration, enhancing efficiency, and reducing on-premises infrastructure costs.

Cloud-based eQMS solutions are increasingly popular due to their accessibility and ease of use. An on-premise solution is also an option, enabling companies to host the system internally, tailored to their specific infrastructure requirements and preferences.

Electronic QMS supports companies in achieving and maintaining regulatory compliance by automating QMS processes, ensuring documentation integrity, and providing real-time monitoring activities.  Important capabilities of an eQMS include centralizing QMS documentation to ensure controlled storage and retrieval of SOPs, CAPA records, complaints, training, and regulatory submissions. Automating compliance monitoring provides real-time dashboards and automated reminders and notifications to prevent compliance gaps. Real-time audit trails contribute to ensuring tamper-evident records of compliance activities.

What is the Difference Between an eQMS and a QMS?

The main difference between an eQMS and a QMS is that an eQMS is a digital, software-based solution accessed via computers, tablets, or mobile phones, enabling process automation and real-time collaboration. In contrast, a traditional quality management system often depends on paper-based documentation and manual processes to manage quality management activities.

In the past, most QMS implementations relied on manual paperwork, physical records, and spreadsheets, making them prone to inefficiencies and errors. Physical documents and records can be scanned and converted into digital formats, such as PDFs, for electronic storage, creating a hybrid system that integrates both paper-based and electronic methods.

Compared to conventional systems, an eQMS provides automated workflow, secure data storage, remote access, and streamlined operations, reducing reliance on manual processes.

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

The main difference between an electronic QMS (eQMS) and an Enterprise QMS (EQMS) is that eQMS solutions suit businesses of all sizes, and EQMS platforms address the complex needs of large organizations.

An electronic QMS digitizes and streamlines quality management processes such as document control, change control, training, audits, corrective actions, and others, providing efficiency and compliance benefits suitable for organizations of various sizes. In contrast, an enterprise QMS offers extensive scalability, advanced integration capabilities across multiple departments or locations, robust analytics, and greater flexibility, specifically designed to handle the complex quality management requirements of large enterprises.

Depending on their needs, enterprises utilize one or more eQMS solutions. These solutions include 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 is suitable for organizations of all sizes, including large enterprises, positioning it as also as an Enterprise Quality Management System (EQMS). SimplerQMS provides comprehensive QMS process support and scalability, enabling efficient multi-site management. Each site can access location-specific documentation while consistently adhering to standardized workflows across the entire organization.  

What Does eQMS Software Do?

The eQMS software automates and streamlines the handling of documents, policies, procedures, and processes within the organization for operational efficiency. The eQMS software provides a centralized repository for all documents and data, making it easy to manage quality processes and workflows. Furthermore, an eQMS automatically generates email reminders and notifications to track and ensure the timely completion of tasks.

A suitable electronic QMS seamlessly integrates with a company’s existing operations, ensuring a harmonious alignment with established quality management processes.

The QMS modules and features that eQMS provides are listed below.

• Document Management: The document management module facilitates the creation, modification, review, approval, and retirement of controlled documents. The system assigns a unique ID to each document. It further includes version control as well as 21 CFR Part 11-compliant electronic signatures.
• Nonconformance Management: eQMS helps track and resolve deviations, nonconformances, customer complaints, and other recorded issues.
• CAPA Management: The CAPA management module streamlines data collection from issues to ensure root cause identification through team involvement, automated notifications, structured CAPA plan execution, and more.
• Complaint Management: Electronic QMS offers complaint management features such as assigning complaint handlers, setting task reminders, and escalating complaints to CAPA, if necessary. The complaint management module has the capability of linking each complaint to the relevant customer, product, and process for traceability.
• Training Management: Automates aspects of employee training to ensure compliance with regulatory and procedural requirements. Access features such as automated assigning of training activities, email notifications, training effectiveness assessments, tracking of training progress, and more help streamline the training management process.
• Change Control: The change control management module allows companies to create, document, and manage all changes within the organization.
• Design Control: The design control feature enables users to create and manage design control documents such as multiple Design History Files (DHF), and Device Master Records (DMR).
• Product Management: The product management module helps companies manage all products and product documentation in one system, such as technical files or device history records (DHR). Features including personalized product item lot numbers, cross-departmental access to approved product data, batch master records, product release notes, and more, enhance operational efficiency.
• Equipment Management: The equipment maintenance and calibration module allows users to create an equipment list organized by categories, schedule calibration and maintenance tasks, monitor equipment status, and more.
• Risk Management: Risk management is often integrated with quality management to identify, assess, and mitigate risks related to products, processes, and compliance.
• Supplier Management: The supplier management module helps streamline supplier evaluation, qualification, and monitoring.
• Audit Management: Audit management supports audit planning, scheduling, execution, documentation, and escalation of audit findings to CAPAs, if necessary.
• Data Analytics and Reporting: Data dashboards in real-time deliver insights into quality trends, performance metrics, KPI reporting, and continuous improvement opportunities.

What Are The Benefits of Using eQMS Software?

The benefits of implementing eQMS software are listed below.

• 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.
• Enhanced Process Efficiency: eQMS optimizes QMS process workflows, such as document control, by reducing administrative or repetitive tasks and manual intervention. By eliminating tedious paper-based tasks, companies achieve higher operational efficiency, faster approval cycles, and real-time process visibility.
• Consistent Product Quality: eQMS helps ensure standardized execution of quality procedures, minimizing deviations and nonconformances. Built-in CAPA management improves quality control and promotes continuous improvement.
• Optimized Collaboration and Communication: The eQMS software fosters collaboration and communication among team members. The software provides a centralized platform for sharing information, feedback, and updates.
• Cost Efficiency: eQMS minimizes operational costs by helping prevent time spent on administrative tasks, reducing waste, and optimizing resource utilization. Data-driven risk management helps reduce recalls, compliance penalties, and production downtime, leading to higher cost savings.
• Audit Readiness: eQMS software maintains real-time audit logs, helping companies prepare for audits and inspections. Features like document retrieval, change tracking, and regulatory reporting help facilitate smooth inspections and compliance verification.
• Data-Driven Decision-Making: eQMS provides analytics such as real-time KPIs 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.

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.

Common steps to follow when choosing an eQMS software are listed 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, vendor features, and services 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 suitable solution.

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

Utilize the eQMS comparison 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.

What Are the Key Considerations When Choosing an eQMS Software?

Below are some considerations for selecting the right QMS software.

• 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, and flexibility, and often include regular updates without requiring extensive on-premise infrastructure.

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.

How Much Does an eQMS Cost?

The cost of eQMS could be in a general range from $5,000 to $15,000 for a company with 5 to 10 employees. For larger organizations with 50 to 200 employees or more, costs can range between $25,000 and $100,000 or higher.

The eQMS price varies depending on features, the number of QMS modules, the maturity of the company’s QMS, compliance requirements, licenses, vendor offerings, and add-ons such as implementation and training.

SimplerQMS provides an all-inclusive solution that includes all QMS modules, system implementation, unlimited 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.

When Is the Right Time to Consider Implementing an eQMS?

The right time to consider implementing eQMS software is when a company has established or is actively developing its QMS and associated documentation.

The six main reasons when to consider an eQMS are listed below.

• Optimizing Implementation of QMS: Implementing an eQMS for companies that haven’t established a QMS helps establish a QMS by ensuring standardized processes, regulatory compliance, and technology integration from the start.
• Improving Communication Across Departments: A centralized repository for all quality-related information data helps ensure seamless access across authorized personnel.
• Automating QMS Processes: An eQMS automates steps of a QMS process to reduce manual effort and save time.
• Improving Compliance Efforts: An eQMS maintains audit trails and enforces standardized workflows to help audit or inspection readiness.
• Gaining Better Visibility into Quality Data: Organizations gain real-time insights through trend monitoring and KPI reporting, which helps in data-driven decision-making.
• Seeking Scalability: An eQMS supports multi-site operations through its cloud-based architecture, enabling seamless expansion alongside business growth or global operations.

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.

How Much Time Does It Take to Implement QMS Software?

Implementing QMS software could be in a range of approximately 2-12 months for most companies. Larger, multinational companies or those requiring extensive customization, document migration, and validation may take more than 12 months.

The implementation timeline for QMS software can be faster or slower and would vary based on company size, and maturity of current QMS and QMS software customization needs. For example, a company with a fully implemented QMS and in the correct file formats can implement an eQMS more quickly, requiring only data migration and training.

Furthermore, the duration of QMS software implementation is influenced by factors such as the number of documents requiring creation or migration and the availability of resources within the company.

SimplerQMS software implementation typically takes as early as 6-8 weeks, deploying the core modules based on specific customer needs or customizable QMS module implementation sequences. The timeframe varies on factors such as document creation, document migration, and customer schedule or availability.

The SimplerQMS implementation follows a structured phase approach such as a kick-off meeting (Week 1), scoping stage (Week 1), integration (Week 1), and configuration (Week 2). Followed by training and workshops (Weeks 3-5), content writing (Weeks 5-6), go-live (Week 7), and formal closure (Week 8) of phase 1.

SimplerQMS offers full implementation, ongoing support, and necessary training at no extra cost, ensuring a streamlined and efficient full implementation process.

What Are the Most Popular QMS Software for Life Sciences?

The 9 most popular QMS software for Life Sciences are listed below.

• 1. SimplerQMS: Cloud-based, fully validated, and comprehensive eQMS software designed for life science companies, including pharmaceuticals, medical devices, and biotechnology.
• 2. Qualio: Cloud-based QMS software for small to mid-sized life science companies
• 3. MasterControl: Enterprise-level eQMS software designed for regulated industries.
• 4. TrackWise: Configurable enterprise QMS offering workflow automation and customizable QMS.
• 5. Ideagen Quality Management: eQMS platform for life sciences, manufacturing, and healthcare.
• 6. Greenlight Guru: A purpose-built eQMS for medical device companies.
• 7. Dot Compliance: Cloud-based eQMS with AI-powered analytics.
• 8. QT9: Cloud-based quality management system serving life sciences, manufacturing, and food and beverage industries.
• 9. Scilife: eQMS cloud platform designed for life sciences companies.

1. SimplerQMS

SimplerQMS is a cloud-based eQMS 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 Office suite, allowing for easy document editing and collaboration using familiar tools such as Word, Excel, and PowerPoint. Additionally, SimplerQMS supports integration with other systems via an open Application Programming Interface (API).

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 SimplerQMS subscription includes all QMS modules, system implementation, unlimited training, validation, hosting, and support.

Users appreciate the ease of use of SimplerQMS and the good value for the price. Customer support of SimplerQMS 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 solutions catering to various industries, including pharmaceuticals, medical devices, and food and beverages. 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 beverages. 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.

Which Industries Can Benefit from SimplerQMS’s eQMS Software?

Industries that benefit from SimplerQMS’s eQMS software are the regulated life science industries listed below.

• Pharmaceuticals: The pharmaceutical industry develops medications and vaccines requiring strict quality and safety standards. Pharmaceutical eQMS software helps pharmaceutical companies ensure compliance with FDA 21 CFR Part 210/211, EU GMP, and ICH Q10 by streamlining batch record management, CAPA management, and other relevant processes.
• Medical Devices: The medical device industry designs, manufactures, and distributes devices used in medical treatments, diagnostics, and patient care. Medical device eQMS software helps companies ensure compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR/IVDR by streamlining design control, supplier management, document control, risk management, complaint handling, and other essential processes.
• Biotechnology: The biotechnology industry focuses on using biological processes to develop technologies and products that help improve our lives and health. Biotechnology eQMS software helps organizations comply with life science-relevant requirements such as ISO 9001:2015, ISO 13485:2016, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), FDA 21 CFR Part 210, 211, and 820, MDR, IVDR, ICH Q10, and others, by streamlining change control, training management, deviation handling, batch record management, and other critical quality processes.
• Clinical Research: The clinical research industry conducts studies to evaluate the safety and efficacy of drugs, medical devices, and treatments. Clinical research eQMS software helps contract research organizations (CROs) and sponsors comply with FDA 21 CFR Parts 50/56, ICH GCP (E6), and GDPR by streamlining trial master file (TMF) management, audit readiness, adverse event reporting, investigator training, and other research-related quality processes.
• Contract Manufacturing: The contract manufacturing industry provides outsourced manufacturing services for pharmaceuticals, medical devices, and biotech companies. Contract manufacturing eQMS software supports compliance with FDA 21 CFR Parts 210/211, ISO 13485, and cGxP guidelines by streamlining supplier quality management, batch record control, CAPA management, nonconformance handling, and other manufacturing quality processes.

Looking to improve quality management in your company? Book a demo to see how SimplerQMS can optimize quality management processes and help ensure compliance.