QMS (Quality Management System): Definition, Types, Documentation, Processes, and Software

A Quality Management System (QMS) is a structured framework that documents processes, procedures, and responsibilities to ensure products or services meet regulatory and customer requirements.

A QMS is tailored to industry-specific needs and requirements, with various QMS types and standards ensuring compliance and continuous improvement through structured approaches.

QMS documentation establishes the framework for consistent quality and compliance by defining policies, procedures, and responsibilities. Building on this foundation, core QMS processes are essential for maintaining product consistency and meeting applicable requirements. Key QMS processes include document control, change control, training, nonconformance management, customer complaints, corrective and preventive actions (CAPA), audits, supplier management, and more.

To establish a QMS, an organization must define its quality objectives, develop documented processes and procedures aligned with applicable requirements, assign roles and responsibilities, and implement systems for monitoring, continuous improvement, and compliance.

QMS software is a digital solution that helps organizations manage and automate quality management processes to ensure consistent quality, streamline workflows, and meet regulatory and customer requirements.

SimplerQMS provides QMS software for life science companies. Book a demo with our Quality Solutions experts to explore SimplerQMS features and how they can benefit your company.

What is a Quality Management System (QMS)?

QMS stands for Quality Management System. A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for ensuring that products or services consistently meet customer and regulatory requirements. Consistent products and services are achieved by maintaining records of activities that indicate that quality-related tasks are being systematically performed.

A QMS in the life science industry ensures products and processes meet regulatory requirements and quality standards. By controlling every aspect of product development and manufacturing, a QMS reduces risks that could impact product safety and quality which can in turn impact consumer safety.

QMS functions include process control, documentation management, risk assessment, and corrective and preventive actions (CAPA). Internal and external audits verify compliance, while training programs enhance staff competency. Continuous improvement strategies optimize system efficiency and reliability. Senior management reviews or management reviews align quality objectives with corporate and regulatory goals, ensuring product integrity and regulatory compliance.

Implementing QMS is important as it supports customer and regulatory compliance, minimizes risks, and streamlines operations. QMS ensures a company consistently delivers uniform and high-quality products or services.

Additionally, QMS enhances customer satisfaction by delivering reliable products or services and reduces costs by preventing errors and inefficiencies. A well-structured QMS drives continuous improvement, strengthens market reputation, and fosters long-term business growth by analyzing data such as complaints.

QMS can be implemented and structured in various formats – electronic, paper-based, and hybrid, each catering to different organizational needs and preferences.

An example of electronic quality management software is SimplerQMS. SimplerQMS offers comprehensive eQMS tailored to the unique needs of life science companies.

What Are the Different QMS Formats?

The different QMS formats are listed below.

• Paper-Based QMS: A traditional QMS format that relies on physical documents and records to implement QMS.
• Spreadsheet-Based QMS: A QMS format that uses spreadsheet applications like Microsoft Excel or Google Sheets to record, track, and manage quality data.
• On-Premise Electronic QMS (eQMS): A digitally managed QMS format installed on an organization’s internal servers, offering customized data control and security.
• Cloud-Based Electronic QMS (eQMS): A Software-as-a-Service (SaaS) QMS format, hosted on external servers and accessed via the internet.
• Hybrid QMS: A mixed QMS format combining electronic and traditional paper-based processes, facilitating gradual digitalization while ensuring compliance.

Paper-Based QMS

Paper-based QMS is the conventional, manual system that relies on physical documents, binders, and records.

Paper-based QMS is easily implemented due to low initial cost and familiarity. Small companies benefit from paper-based QMS without technical expertise or software investment. Growing organizations, however, face inefficiencies, higher error risk, version control issues, and compliance challenges.

Spreadsheet-Based QMS

A spreadsheet-based QMS leverages Microsoft Excel, Google Sheets, or similar tools to track quality metrics, manage documents, and maintain records.

A spreadsheet-based QMS is a low-cost, customizable approach with more structure than paper-based systems. The downside of this format of QMS is that it remains prone to human errors, lacks automation, and complicates version control, making audits and regulatory compliance more challenging. As businesses grow, scaling becomes inefficient, limiting its long-term viability.

Spreadsheet-based systems can serve as part of a hybrid QMS alongside electronic or paper-based methods, enabling a gradual shift toward digitalization while maintaining compliance and flexibility.

On-Premise Electronic QMS (eQMS)

An on-remise electronic QMS is a software installed on a company’s local servers. An on-premise eQMS enables the management of electronic document control, audit tracking, and other QMS processes.

For organizations with strict and regulatory requirements, on-premise eQMS is ideal because it provides high security, extensive customization, and full data control on their own servers. Despite its advantages, on-premise eQMS requires significant upfront investment and dedicated IT maintenance and has limited remote accessibility compared to cloud-based eQMS solutions.

Cloud-Based Electronic QMS (eQMS)

A cloud-based electronic QMS is a platform hosted in the cloud facilitating centralized quality management and real-time collaboration.

The advantages of cloud-based eQMS are that it offers scalability, remote accessibility, automated updates, and reduced IT maintenance. A cloud-based eQMS supports workflow automation, flexibility, and seamless integration with remote teams. It involves ongoing subscription costs and relies on stable internet connectivity.

Hybrid QMS

Hybrid QMS is a quality management system that combines electronic or digital solutions with traditional paper-based or on-premises methods, allowing organizations to gradually transition toward full digitalization while maintaining compliance with regulatory requirements.

Despite providing cloud-based accessibility and scalability potential, hybrid QMS introduces complexities. This includes system integration, potential data silos, and requires careful management for seamless integration.

Why is Quality Management System (QMS) Important?

QMS is important for standardizing QMS processes. QMS outlines formal procedures, such as SOPs and work instructions, that govern each stage of product development, manufacturing, and service provision. Organizations can ensure consistent outcomes and reduce variability by following these defined procedures.

QMS is required to maintain product quality. Regular checks, process controls, and inspections help verify that products conform to predefined specifications and quality standards. QMS extends to external sources by establishing criteria for material acceptance and evaluating suppliers, thereby helping to ensure raw material quality and services.

QMS is vital to mitigating risks. For instance, a robust CAPA system, as one of the core processes of QMS facilitates rapid issue identification, investigation of root causes, and resolution of recorded issues (e.g. deviations, nonconformities, complaints, and audit findings).

Furthermore, a QMS is important for ensuring compliance with applicable requirements and maintaining consistent product or service quality. A QMS helps organizations meet customer and regulatory requirements while improving efficiency, reducing waste, and minimizing costs.

What are the Benefits of Quality Management Systems?

Listed below are the 10 main benefits of quality management systems.

1. Improved Regulatory Compliance: QMS ensures companies comply with industry regulations, ISO standards, and guidelines, reducing noncompliance risks and potential penalties.
2. Increased Customer Retention and Satisfaction: QMS guarantees consistent product and service quality, fostering loyalty and increasing the likelihood of repeat business.
3. Encouraged Continuous Improvement: QMS encourages a culture of continuous improvement, empowering companies to identify areas for improvement, implement changes, and optimize processes over time.
4. Standardized Operational Processes: QMS establishes standardized processes, leading to consistent and reliable outcomes, reducing variability, and ensuring a uniform approach across operations.
5. Strengthened Internal Communications: QMS enhances cross-functional collaboration, ensuring clear communication across teams, departments, and management.
6. Streamlined Employee Training: QMS provides a structured framework for employee training, ensuring that staff members are adequately trained and qualified to perform their roles efficiently.
7. Increased Efficiency and Waste Reduction: QMS identifies and eliminates inefficiencies, resulting in streamlined processes, reduced waste, and optimized resource utilization, which contribute to cost savings.
8. Improved Decision-Making: QMS enables businesses to leverage quality data analytics, improving strategic decision-making.
9. Improved Company Culture: QMS fosters a culture of quality, accountability, and continuous improvement, creating a positive work environment and aligning employees with organizational goals.
10. Increased Profits: QMS contributes to revenue growth through improved efficiency, customer satisfaction, and reduced costs.

What are the Different Types of Quality Management Systems?

The different types of Quality Management Systems include life science QMS, pharmaceutical QMS, medical device QMS, laboratory QMS, biotechnology QMS, clinical QMS, and others. These types of quality systems are tailored to the specific needs and requirements of the implementing company. The nature of a QMS depends significantly on the industry in which the company operates and the applicable customer and regulatory requirements.

For instance, pharmaceutical QMS systems must follow regulations and requirements, such as FDA 21 CFR Parts 210/211 or EU GMP. FDA 21 CFR Part 820, EU MDR, and ISO 13485 are for the medical devices industry. Laboratory QMS systems reference ISO 17025 and Good Laboratory Practices (GLP) for specific testing environments.

Life Science Quality Management Systems

A life science quality management system is a structured framework for documenting processes, procedures, and responsibilities in companies within the life science industries, including pharmaceuticals, biotechnology, and medical devices. The key objective of life science QMS is to ensure regulatory compliance with FDA, EMA, and GxP requirements and customer requirements. 

Some of the different types of life science QMS are listed below.

• Pharmaceutical Quality Management System: A pharmaceutical QMS manages organizational processes, documentation, and responsibilities to maintain quality, safety, and compliance in pharmaceutical manufacturing. A pharmaceutical QMS aims to ensure product quality and safety throughout the pharmaceutical manufacturing process. Applicable requirements for pharmaceutical QMS include Good Manufacturing Practices (GMP), FDA 21 CFR Parts 210/211, ICH Q10, and ISO 9001.
• Medical Device Quality Management System: A medical device QMS is a regulatory-driven quality system that documents policies, procedures, and processes to ensure medical devices are safe, effective, and compliant throughout their lifecycle. The medical device QMS goal is to ensure the safety and effectiveness of medical devices throughout their lifecycle, from design and development to manufacturing, distribution, and end-use. Applicable requirements include FDA 21 CFR Part 820, EU MDR, EU IVDR, and ISO 13485.
• Laboratory Quality Management System: A Laboratory QMS is a structured framework that standardizes processes, documentation, and responsibilities to maintain accurate and reliable laboratory testing and research. A laboratory QMS aims to help ensure accurate and reliable test results, maintain data integrity, and achieve compliance with customer and regulatory requirements.  Applicable requirements for a Laboratory QMS include GLP, ISO/IEC 17025, and ISO 15189, among others.
• Biotechnology Quality Management System: A Biotechnology QMS ensures compliance with regulatory requirements and industry standards in biotechnology. This biotechnology QMS maintains product safety, efficacy, and quality across research, development, production, and distribution in the biotechnology industry. Relevant requirements often include FDA 21 CFR Parts 210/211, GMP, GLP, ISO 9001, and ISO 13485 depending on the nature of the biotechnology product.
• Clinical Quality Management System: A Clinical QMS is a formalized system designed to manage processes, procedures, and responsibilities within clinical research, clinical trials, and healthcare settings, ensuring clinical trials’ quality, integrity, andsafety. Pharmaceutical and medical device QMS frameworks often integrate clinical QMS, as clinical trials are essential for drug and device development and approval. Clinical QMS ensures patient safety, data integrity, and compliance with customer and regulatory requirements throughout clinical trials and healthcare delivery. Applicable requirements such as FDA 21 CFR Parts 50/56, ICH GCP (E6), EU Clinical Trial Regulation, and any relevant local requirements.
• Healthcare Quality Management System: A Healthcare QMS is designed to optimize patient care, hospital management, and regulatory compliance within healthcare facilities and medical institutions. This healthcare QMS enhances patient safety, clinical outcomes, and operational efficiency while ensuring adherence to healthcare standards such as the Health Insurance Portability and Accountability Act (HIPAA) and Joint Commission International (JCI).

Other industry-specific quality management systems are designed to ensure product quality, regulatory compliance, and operational efficiency within their respective sectors. Examples include QMSs used in general manufacturing, food and beverage, automotive, and aerospace and defense – each aligned with relevant requirements such as ISO 9001, ISO 22000, FSSC 22000, IATF 16949, and AS9100.

Common QMS Requirements

The common QMS requirements across different industries are listed below.

• ISO 9001:2015: The ISO 9001:2015 standard establishes the general requirements for quality management systems. ISO 9001:2015 applies across various industries and defines Quality Management System (QMS) requirements. For instance, some pharmaceutical companies and general manufacturing industries use ISO 9001 to structure their QMS.
• ISO 13485:2016: ISO 13485:2016 outlines QMS requirements for medical device manufacturing. A QMS compliant with ISO 13485:2016 provides a structured framework for designing, developing, producing, installing, and servicing medical devices, ensuring consistent delivery of safe and effective products.
• FDA 21 CFR Part 820: The FDA 21 CFR Part 820, also known as the Medical Device Quality System Regulation (QSR), is a regulation established by the US FDA. FDA 21 CFR Part 820 specifies the Current Good Manufacturing Practices (cGMP) requirements for medical devices. This regulation applies to medical device manufacturers seeking to distribute their products commercially in the United States.
• ISO 15189:2022: The ISO 15189:2022 standard defines the requirements for quality and competence in medical laboratories, including guidelines for a robust QMS. This ISO 15189:2022 standard ensures laboratory services’ accuracy, reliability, and quality, ultimately enhancing patient safety and well-being.
• ISO 17025:2017: The ISO 17025:2017 standard outlines the general requirements for the competence, impartiality, and consistent operations of laboratories. This standard outlines the necessary management system and documentation requirements to ensure reliability. This standard applies to testing and calibration laboratories performing various analyses or measurements across multiple fields, including those within the life sciences industries.
• ICH Q10: The ICH Q10 guideline defines the requirements for the Pharmaceutical Quality System (PQS). ICH Q10 presents a comprehensive model for an effective quality management framework. It applies to pharmaceutical and biopharmaceutical companies involved in the development and manufacture of drug substances and drug products.
• AS9100: AS9100 is an aerospace, space, and defense industry-specific QMS standard that extends ISO 9001 with additional risk management, product reliability, and regulatory compliance requirements for high-risk sectors. Companies adopting AS9100-certified QMS gain a competitive edge by ensuring product reliability, supply chain integrity, and adherence to international safety standards.
• IATF 16949: IATF 16949 defines the criteria for an automotive-based QMS developed by the International Automotive Task Force (IATF). By implementing IATF 16949 QMS, manufacturers and suppliers achieve higher efficiency, defect reduction, and supply chain excellence, ensuring compliance with global automotive standards.
• Hazard Analysis and Critical Control Points (HACCP): HACCP is a preventive food safety management system (FSMS) designed to identify, assess, and control potential hazards in food production, processing, and distribution. HACCP ensures consumer safety, regulatory compliance, and food quality by systematically analyzing risks and implementing critical control measures.
• ISO 22000: ISO 22000 is an international standard for Food Safety Management Systems (FSMS) that establishes requirements for identifying, controlling, and preventing food safety hazards across the entire food supply chain. ISO 22000 integrates HACCP principles, risk management, traceability, and regulatory compliance, ensuring that organizations consistently produce safe food products.

What are the Different Approaches and Methodologies of QMS?

The different approaches and methodologies of QMS include continuous quality improvement (CQI), total quality management (TQM), lean manufacturing, Six Sigma, and agile QMS.

QMS approaches and methodologies refer to structured frameworks, principles, and techniques used to implement and improve QMS within an organization.These methodologies enhance efficiency, consistency, and customer satisfaction while minimizing risks and operational inefficiencies.

Some of the different approaches and methodologies of QMS are listed below.

• Continuous Quality Improvement (CQI): CQI focuses on identifying, analyzing, and refining processes to enhance efficiency, effectiveness, and customer satisfaction. CQI is recognized as a best practice across industries to meet evolving customer and regulatory demands, although not mandatory.
• Total Quality Management (TQM): TQM is a quality management approach to achieve continuous improvement in the quality of products, services, and processes. TQM fosters teamwork and a culture of excellence across the organization but is not required by regulations.
• Lean Manufacturing: Lean Manufacturing is a QMS methodology designed to minimize waste and maximize efficiency by eliminating non-value-added activities. Often adopted voluntarily in manufacturing, it aims to improve competitiveness and customer satisfaction.
• Six Sigma: Six Sigma is a statistical QMS methodology that aims to identify and eliminate defects, reduce process variations, and improve overall quality. Six Sigma follows a DMAIC cycle (Define, Measure, Analyze, Improve, Control) for continuous improvement. It is optional and can be implemented in any organization aiming to enhance quality and reduce errors.
• Agile Quality Management: Agile Quality Management is a QMS approach that emphasizes flexibility, collaboration, and adaptability in quality control processes.  Many companies adopt Agile Quality Management to rapidly meet shifting requirements and better serve customer needs, while not a mandated approach.

What is QMS Documentation Structure?

Quality management system documentation is the Quality Manual that defines a company’s quality system. QMS documentation includes policies, procedures, work instructions, records, and other relevant documents.

QMS documentation structure is a hierarchical organization of documents. The document hierarchy facilitates comprehension, communication, and visualization of the documentation structure.

The four levels of documents in a QMS pyramid are described below.

• Policies: QMS policies, such as quality policies and company policies, are high-level statements that serve as the foundation for all supporting QMS documents. These policies set the overall direction for quality efforts and serve as a guiding principle for employees.
• Procedures: Procedures outline the step-by-step methods or processes for performing specific tasks or activities. Procedures serve to standardize operations, ensure consistency, and facilitate compliance with regulatory requirements.
• Work Instructions: Work instructions provide detailed guidelines for completing specific tasks or operations, often at a more granular level than procedures. Work instructions are used to ensure that tasks are performed correctly, safely, and efficiently.
• Records: Records document the results, activities, or events related to quality management processes, such as audits and training. Records serve as evidence of performance and compliance, enabling traceability and accountability.

The four levels of documents in a QMS pyramid are shown in the image below.

What are the Core Quality Management System Processes?

The core QMS processes are the fundamental activities that ensure consistent quality, compliance, and continuous improvement in an organization.

The core QMS processes are listed below.

• Document Control: Document control ensures that all QMS-related documents and records remain current, accurate, and accessible, supporting regulatory compliance, consistency, and traceability.
• Change Management: Change management provides a structured QMS process for evaluating and implementing changes within the organization.
• Training Management: Training management ensures that employees are equipped with the necessary knowledge and skills to perform their jobs effectively.
• Deviation and Nonconformance Management: Deviation and nonconformance management systematically identifies, documents, investigates, and resolves process deviations.
• Complaint Management: Complaint management formalizes a structured QMS process for receiving, evaluating, and resolving customer complaints.
• Corrective Action and Preventive Action (CAPA) Management: CAPA management is a QMS-driven process focused on identifying, resolving, and preventing recorded issues such as deviations, nonconformances, complaints, and audit findings.
• Equipment Management: Equipment management ensures proper registration, qualification, calibration, maintenance, and disposal of equipment used in manufacturing and quality control processes.
• Supplier Management: Supplier management maintains a structured QMS framework for evaluating, selecting, and monitoring suppliers to minimize risks and ensure high-quality product sourcing.
• Risk Management: Risk management systematically identifies, assesses, mitigates, and monitors risks that could impact product quality, safety, or regulatory compliance.
• Audit and Inspection Management: Audit and inspection management ensure systematic planning, execution, and review of audits and inspections to assess QMS compliance.

The fundamental core QMS processes are summarized in the image below.

Document Control

Document control is the management of QMS-related documents and records. Document control ensures that relevant documentation, such as policies, procedures, work instructions, and specifications, are created, reviewed, approved, updated, and retired as necessary. 

By establishing robust document control procedures, companies can mitigate the risk of errors, inconsistencies, and outdated information.

Additionally, effective document management facilitates transparency, accountability, and traceability.

Change Management

Change management is a systematic QMS approach to implementing process modifications, product updates, and workflow improvements.

Change management ensures that any alterations made to the quality processes are carefully evaluated to minimize risks and maximize benefits.

Change management is essential to a QMS as it enables companies to adapt to evolving regulatory and customer requirements whilesafeguarding quality and compliance.

Training Management

Training management is the process that equips personnel to possess the necessary skills, knowledge, and expertise to perform their job effectively.

By providing comprehensive training programs, companies ensure employees understand their roles, responsibilities, and requirements of a QMS.

Effective training management helps minimize errors and improve productivity.

Deviation and Nonconformance Management

Deviation and nonconformance management are the systematic process of identifying, documenting, investigating, resolving, and preventing deviations or nonconformances related to procedures, products, suppliers, and more.

Deviation and nonconformance management ensure product quality, safety, and regulatory compliance. When deviations or nonconformities occur, addressing them promptly and effectively is essential to prevent recurrence, minimize the impact on product quality and safety, and ensure continuous improvements.

Complaint Management

Complaint management is a formal QMS process for receiving, documenting, investigating, and resolving customer complaints to improve product quality and compliance.

Complaint management enables companies to respond effectively to customer feedback, address quality issues, and drive continuous improvement. By prioritizing customer satisfaction and actively engaging with customer complaints, companies can build trust, loyalty, and long-term relationships with their customers while maintaining compliance with regulatory requirements.

Corrective Action and Preventive Action (CAPA) Management

CAPA management is a QMS process designed to identify, resolve, and prevent recorded issues from recurrence or avoid issue occurrence. CAPA involves investigating root causes through structured methodologies such as 5 Whys and Fishbone Diagrams. CAPA implements corrective and preventive measures based on those findings and verifies the effectiveness of these actions in eliminating or mitigating the associated risks.

Companies can minimize risks, improve processes, and ensure continuous improvement by implementing effective CAPA processes.

Equipment Management

Equipment management is a systematic approach to ensuring the ongoing functionality, accuracy, and reliability of all equipment used within the companies’ processes.

Equipment management involves registration, qualification, calibration, maintenance, and disposal of equipment used in the manufacture of products.

Properly managed equipment ensures that manufacturing processes are conducted accurately and consistently, minimizing the risk of defects or deviations from quality specifications.

Supplier Management

Supplier management is a QMS process that ensures suppliers meet quality and compliance requirements.

Supplier management involves evaluating, selecting, and monitoring suppliers to ensure that they consistently deliver uniform and high-quality products or services.

Effective supplier management helps companies identify reliable and capable suppliers, optimize supply chain performance, and mitigate risks associated with poor supplier performance.

Risk Management

Risk management within a QMS framework focuses on identifying, assessing, mitigating, and monitoring risks that could impact product quality, safety, and regulatory compliance.

By proactively identifying and assessing risks, companies can implement strategies to mitigate or eliminate risks, thereby reducing the likelihood of quality incidents like nonconformance and deviations.

Audit and Inspection Management

Audit and inspection management is a QMS process that ensures internal and external audits are effectively planned, executed, and reviewed.

Audit and inspection management ensures that quality management processes are effectively implemented and followed across the company. Audit and inspection management assesses compliance with internal policies, procedures, quality standards, industry guidelines, and regulatory requirements.

How to Establish and Implement a Quality Management System?

The typical steps in establishing and implementing a quality management system are listed below.

1. Define Quality Objectives and Scope: Establish business goals and customer and regulatory requirements to align with organizational needs. To ensure the inclusion of all applicable processes and departments, establish the scope of the QMS.
2. Develop a Quality Policy and Leadership Commitment: Formulate a quality policy that aligns with the strategic objectives of the organization. Additionally, establish leadership commitment by ensuring top management actively supports quality and continuous improvement within the QMS.
3. Identify and Document Key Processes: Create a clear mapping of core business processes and define their interactions within the QMS. Establish Standard Operating Procedures (SOPs), work instructions, and process guidelines for relevant processes to maintain consistency and compliance.
4. Implement Document Control and Record Management: Establish a centralized document control system for version management and accessibility. Set up compliance measures with relevant industry standards within the QMS, depending on the industry. For example, use ISO 13485 for medical devices and ISO 9001 for the pharmaceutical industry.
5. Train Employees and Build Quality Awareness: Create training programs to educate employees on QMS procedures and regulatory compliance. Launch a culture of quality, accountability, and continuous improvement within the organization.
6. Establish Risk Management and CAPA Processes: Initiate risk assessment methodologies, such as Failure Mode and Effects Analysis (FMEA), to identify potential issues. Establish Corrective and Preventive Actions (CAPA) within the QMS to systematically address recorded issues.
7. Set Up Internal Audit and Compliance Monitoring: Establish regular internal audit schedules to assess the effectiveness of the QMS. Create monitoring mechanisms to ensure ongoing regulatory compliance and process improvements.
8. Measure Performance and Continuous Improvement: Formulate key performance indicators (KPIs) such as customer complaints, defect rates, and process efficiency metrics. Establish continuous improvement initiatives using methodologies like 5S, Six Sigma, and Total Quality Management (TQM).
9. Prepare for Certification and Regulatory Audits: Begin gap assessments and corrective action plans to prepare for external audits. Prepare necessary documentation and procedural alignment with ISO, FDA, and GMP standards within the QMS.
10. Review and Optimize the QMS Regularly: Determine the schedule for periodic management reviews to assess QMS performance and effectiveness. Establish necessary updates based on audit findings, feedback, and regulatory changes.

What is Quality Management Software?

Quality management software is a digital platform designed to streamline and automate quality management processes while ensuring compliance with standards, guidelines, and regulations. This quality management software enables systematic control of quality policies, procedures, and documentation, facilitating adherence to applicable requirements.

QMS software streamlines and automates key QMS processes such as document control, change management, training management, audit management, nonconformance management, deviation management, CAPA management, and supplier management.

What are the Benefits of Implementing QMS Software?

The main benefits of using QMS software are listed below.

• Improved Compliance: QMS software helps companies comply with regulatory and customer requirements. The software’s workflows ensure processes are being correctly followed. All actions in the workflow are automatically documented in a time-stamped audit trail.
• Enhanced Efficiency: Quality management software automates and streamlines quality management processes, reducing manual effort and minimizing errors. The implementation of QMS software leads to increased productivity and operational efficiency within the company.
• Increased Transparency: QMS software provides real-time visibility into quality management activities, allowing employees to access relevant data. Transparency fosters accountability, facilitates collaboration, and promotes informed decision-making.
• Cost Savings: QMS software reduces the need for manual paperwork, streamlines processes, and helps prevent non-value-adding tasks. As a result, companies can achieve cost savings through improved efficiency, reduced waste, and decreased risk of noncompliance.

At SimplerQMS we designed a QMS software business case template to assist you in assessing the value of implementing modern QMS software and presenting it to your management.

The business case template is tailored to help you visualize the specific benefits that cloud-based QMS software can bring to your business, including potential efficiency enhancements, cost reductions, and improvements in compliance.

Assess the benefits of investing in an eQMS solution for your company by downloading our QMS Software Business Case template.

How to Choose Quality Management Software?

The main steps to choosing quality management software are mentioned below.

1. Assess Your Requirements: Evaluate the company’s quality management needs and objectives, considering factors such as regulatory compliance requirements and process requirements.
2. Research and Compare QMS Software Vendors: Research multiple QMS software vendors, comparing features, pricing, customer reviews, and industry reputation to identify potential candidates.
3. Select Relevant QMS Software Vendors: Pick out QMS software vendors whose offerings align closely with the company’s requirements and objectives, ensuring vendors have a proven track record in the industry.
4. Get Demos and Have Meetings: Request demonstrations and schedule meetings with selected vendors to gain a deeper understanding of their software’s capabilities and how it can address specific needs.
5. Consider Getting a Trial: Explore the possibility of obtaining a trial period from the vendors under consideration, allowing employees to test the software in a real-world setting.
6. Shortlist QMS Software Vendors: Create a shortlist of the most promising QMS software vendors based on their presentations, feedback from demos, and alignment with the company’s needs.
7. Get Demonstration of Specific Use Cases: Ask shortlisted vendors to provide demonstrations focused on specific use cases relevant to the company, ensuring their software can effectively address particular challenges.
8. Negotiate With Shortlisted QMS Providers: Engage in negotiations with the shortlisted QMS providers to discuss pricing, licensing terms, support services, any other add-ons, and any customization options required.
9. Make Final Decision: Make a final decision based on a comprehensive evaluation of each vendor’s offerings, taking into account factors such as functionality, cost-effectiveness, vendor support, and potential for long-term value.

Simplify the decision-making process of choosing QMS software with our QMS Software Comparison Template.

Use the eQMS comparison template to conduct a thorough comparison of various eQMS solutions, evaluating vendor features, functionalities, pricing structures, and more. The comprehensive side-by-side comparison helps you understand exactly what each QMS software and vendor has to offer.

What Key Features to Consider When Choosing a QMS Software?

Key features to consider when choosing a QMS software include the listed below.

• Quality Management Module: Define the company’s specific quality processes, compliance needs, and essential eQMS modules such as document control, training management, supplier management, and more.
• Validation and Compliance: Choose QMS software that includes alignment with applicable QMS requirements such as ISO 13485, FDA 21 CFR Part 820, GxPs, and more. For example, Life Science QMS software should follow validation frameworks like ISPE GAMP 5 and comply with applicable software requirements such as FDA 21 CFR Part 11 and EU Annex 11.
• Training and Support: Assess vendor-provided training and support to ensure users can effectively utilize the system and receive assistance when needed.
• Cloud-Based Solutions: Consider cloud deployment for greater accessibility, flexibility, and automatic updates without requiring extensive IT infrastructure.
• Additional Capabilities: Evaluate features such as dashboards, mobile access, document editing, integration options, and reporting tools.

Selecting the right QMS software requires a thorough evaluation to ensure it aligns with business needs and regulatory requirements.

What are the Most Popular QMS Solutions for Life Sciences?

The 9 most popular QMS solutions for Life Science companies are as follows.

• 1. SimplerQMS: SimplerQMS is a QMS software designed for companies in the Life Science industry, including medical devices, pharmaceuticals, laboratories, and biotechnology. Renowned for its comprehensive support of all Life Science QMS processes, extensive module offering, and ease of use, it stands as an effective QMS software solution for these industries. SimplerQMS is integrated with Microsoft Office and requires no additional validation from customers since it is fully validated according to GAMP5.
• 2. Qualio: Qualio is a QMS software for Life Science companies that is tailored specifically for growing companies and startups. Qualio is known for its native web-based document editor, which facilitates transparent document management processes.
• 3. MasterControl: MasterControl is a QMS software designed for various Life Sciences, especially large enterprises. MasterControl is renowned for its comprehensive document control and quality management solutions that are compliant with FDA 21 CFR Part 11 regulation.
• 4. TrackWise: TrackWise is a QMS software designed for industries such as pharmaceuticals, biotechnology, medical devices, diagnostics, and food and beverage. TrackWise is known for its AI-augmented decision-making capabilities, enabling a shift from reactive to proactive quality management.
• 5. Ideagen Quality Management: Ideagen Quality Management, formerly Q-Pulse, is a QMS software designed for various industries, including Life Sciences. Ideagen Quality Management stands out for its extensive array of QMS modules and its utilization of Microsoft Office applications for document editing, along with offering e-learning capabilities.
• 6. Greenlight Guru: Greenlight Guru is a cloud-based QMS software designed for the MedTech industry. Greenlight Guru is renowned for its requirements management and traceability matrix capabilities, and native document editing features, which simplify workflows with in-app editing.
• 7. Dot Compliance: Dot Compliance is a QMS software designed for Life Sciences companies. Dot Compliance is renowned for its AI assistant, Dottie AI, which automatically scans vast amounts of text and diverse data, identifies correlations, and provides ongoing, up-to-date AI insights.
• 8. QT9: QT9 is a web-based eQMS that provides a quality management solution for various industries, including medical devices, pharmaceuticals, chemicals, manufacturing, food and beverage, cosmetics, and more. QT9 QMS is renowned for its extensive range of over 23 built-in QMS modules.
• 9. Scilife: Scilife is a QMS software designed for the Life Sciences industry. Scilife is known for its comprehensive QMS modules. The software is validated according to GAMP 5 on the Amazon Web Services (AWS) platform.

Which Industries Can Benefit from SimplerQMS’s eQMS Software?

Industries that can benefit from SimplerQMS’s eQMS software are listed below.

• Pharmaceuticals: The pharmaceutical industry produces medications and vaccines under stringent quality and safety requirements. Pharmaceutical QMS software helps companies ensure compliance with FDA 21 CFR Part 210/211, EU GMP, and ICH Q10 and streamline tasks such as batch record management, CAPA procedures, and other related activities.
• Medical Devices: The medical devices industry is responsible for designing, manufacturing, and distributing devices used in medical diagnostics and treatment. QMS software for medical devices helps ensure compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR/IVDR by enhancing design control, document management, supplier management, risk assessment, complaint handling, and other essential processes.
• Biotechnology: Biotechnology is focused on harnessing biological processes to create products that advance health and well-being. Biotech companies use specialized biotechnology eQMS to meet requirements like ISO 9001:2015, ISO 13485:2016, GMP, GLP, FDA 21 CFR Parts 210, 211, and 820, MDR/IVDR, and ICH Q10. QMS software streamlines change management, training, deviation resolution, batch record oversight, and other critical quality processes.
• Clinical Research: Clinical research is centered on evaluating the safety and effectiveness of drugs, medical devices, and treatments. The clinical research companies use clinical research eQMS software to ensure adherence to FDA 21 CFR Parts 50/56, ICH GCP (E6), and GDPR. By improving trial master file (TMF) management, audit readiness, adverse event tracking, investigator training, and related processes, eQMS solutions, such as SimplerQMS, help ensure compliance and improve operations.
• Contract Manufacturing: Contract manufacturing provides outsourced production services for pharmaceuticals, medical devices, and biotech products.Contract manufacturing organizations use an eQMS to comply with FDA 21 CFR Parts 210/211, ISO 13485, and GxP guidelines. Contract manufacturing companies can ensure high manufacturing quality and consistency by using QMS software to streamline supplier quality management, batch record control, CAPA processes, nonconformance handling, and other related QMS processes.

SimplerQMS helps life science companies ensure compliance with applicable requirements such as FDA 21 CFR 820, EU MDR (Regulation (EU) 2017/745), ISO 9001, and ISO 13485:2016, to mention a few, by assisting companies in streamlining their QMS processes.

To learn more about this QMS software and how it can streamline your QMS processes, consider booking a demo with our Quality Solutions expert today!