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The Ultimate Guide to QMS Software

Quality is always a top priority for life sciences companies looking to develop safe and effective products. To maintain a competitive advantage in today’s global market, companies are tasked with maximizing productivity, while meeting customer expectations and regulatory requirements. To meet these goals, many organizations rely on enterprise quality management system (QMS) software solutions to get high-quality products to market fast. In this guide, we reveal everything you need to know about QMS software and outline the key factors that you should consider when exploring the best way to establish compliant quality management processes.

What Is a Quality Management System (QMS)?

The Ultimate Guide to QMS Software

A QMS is a formalized system (paper- or software-based) of documenting responsibilities, processes, and procedures to develop products that meet customer requirements as well as compliance with FDA, ISO, EU MDR, and other regulatory standards. An effective QMS should align with your business goals by providing greater transparency and traceability from concept through commercialization. While QMS  can be manual, quality management system software solutions are far more effective at eliminating silos, quality issues, and manufacturing mistakes by keeping dispersed teams on the same page at all times.

Why Is QMS Important?

Quality management systems help drive continuous improvement and provide a systematic approach to identify quality issues, improve product performance, lower manufacturing costs, and reduce waste. More and more organizations rely on a QMS to meet FDA, EU MDR, and ISO regulatory standards and reduce audit risks and consequences.

The History of QMS

Continuous Improvement IPDCA

The origin of QMS can be traced back to the 1920s when engineer Walter Shewhart developed statistical quality control methods to help businesses improve their production processes. Engineer and statistician William Deming successfully applied Shewhart’s methods to manufacturing during World War II. This enabled armed forces to speed up inspections without compromising quality.

Shewhart’s methods (also known as the Shewhart cycle) served as the basis for the Plan-Do-Check-Act (PDCA) cycle, which is a key component of many of today’s quality management systems.1

During the 1950s and 1960s, Japan adopted the concept of quality management to rebuild its economy after the devastation of the war. Japanese manufacturers enlisted the help of Deming and Joseph Juran for their quality expertise. With guidance from Deming and Juran, Japanese manufacturers were able to develop increasingly higher quality products at lower prices, which led to an economic boom in the decades that followed.2,3

In the 1980s, the American economy suffered from its inability to compete with Japan. This led to the adoption of total quality management (TQM), which served as the basis for quality and operational excellence in the United States.2,3

Today, organizations have adopted newer approaches to quality management, such as Six Sigma and lean manufacturing. Companies also rely on enterprise QMS solutions to help manage and track all of the processes and records that are a part of their quality system.

Meeting ISO 9001, FDA, EU MDR, and Other QMS Standards

ISO 9001 Compliance
ISO 9001:2015 is a standard within the ISO 9000 family of international quality standards that is considered the most widely adopted approach to quality management systems. Many organizations use ISO 9001 as the basis to develop their own quality management program. Other ISO standards related to QMS include:

  • ISO 13485 (QMS for medical devices)
  • ISO 14971 (Risk management for medical devices)
  • ISO 9004 (Continuous improvement/guidance to achieving sustained success)

U.S. Food and Drug Administration (FDA) Compliance
The FDA mandates that medical device, biotechnology, and other life sciences companies must establish and follow quality systems to ensure their products consistently meet applicable requirements and specifications for the U.S. market.

The FDA’s quality system regulation specified under Title 21 CFR Part 820 establishes that medical device manufacturers must establish and follow current good manufacturing practices (CGMPs) for the design, manufacture, installation, and servicing of safe and effective devices4. In the near future, the FDA is expected to revise its current Title 21 CFR Part 820 quality system regulation to more closely align with ISO 13485. This will enable medical device manufacturers to have a more globally harmonized QMS.

Design controls are at the heart of the FDA’s quality system regulation and ISO 13485. The FDA specifies the necessary steps and procedures for each design phase. These design controls govern the processes throughout new product development and introduction (NPDI). The FDA also defines how manufacturers demonstrate compliance. This includes the provision of two pieces of compliance evidence—the design history file (DHF) and the device master record (DMR).

Medical device companies that use electronic systems to track DMRs, employee training records, corrective actions, or other data requiring traceable documentation as part of their QMS must also comply with FDA Title 21 CFR Part 11. This regulation establishes the criteria under which electronic records and signatures are deemed trustworthy, reliable, and generally equivalent to those executed on paper.

EU MDR Compliance
Regulatory standards for medical devices in the European Union (EU) are established through the EU Medical Device Regulation 2017/745 (EU MDR) by the European Commission. Medical devices and other products covered under the EU MDR are required to have a Conformitè Europëenne (CE) Mark in order to be sold in the European Economic Area (EEA). The CE marking (symbol) represents a manufacturer’s declaration that products comply with all applicable European laws or directives with respect to safety, health, environment, and consumer protection.

Underwriters Laboratories
Agencies like Underwriters Laboratories (UL) also set industry-wide safety and quality standards for new products. UL testing makes sure that electric circuitry is correct and that devices can handle the amount of current as claimed by the manufacturer. It also ensures that products are constructed correctly for the highest safety. Products that are UL tested typically carry a UL stamp (similar to the CE Mark) and are assigned one of the following UL designations:

  • UL Listed: This designation means that the product meets the laboratory’s standards and can be used by itself for a specific purpose.
  • UL Recognized: This designation is granted to equipment components that are used in combination with other pieces of equipment to create a finished product.
  • UL Classified: This designation means that a product has only been evaluated for specific properties regarding a limited range of standards or for use under certain conditions.

What Is QMS Software?

Product Design ManagementQMS software provides a controlled and automated way to manage quality and product record processes throughout the product lifecycle. It brings quality records and the entire product design (i.e., mechanical, electrical, and software) into one shared system—enabling engineering, quality, manufacturing, related product teams, and supply chain partners to collaborate in real-time throughout the new product development and introduction (NPDI) process.

Cloud-based QMS solutions sold under software-as-a-service (SaaS) subscription models eliminate collaboration latency, data errors, and security issues with a persistent digital thread that leads to greater audit confidence and faster product launches. By utilizing a pay-as-you-go subscription, SaaS QMS software also reduces infrastructure expenses and large upfront software purchases that are associated with traditional on-premises platforms.

8 Essential Elements of Enterprise QMS (eQMS) Software

  1. BOM Management
    The ability to effectively manage your complete product record, including the ensures that the most current product revisions are always controlled and accessible by all members of the quality, product, and extended supply chain teams. It also ensures that device master records (DMRs), design history files (DHFs), parts, standard operating procedures (SOPs), and drawings are connected to the product record making it easier to manage closed-loop quality processes.
  2. Engineering Change Management
    Engineering change management provides controlled design change processes that speed product development. Product team members can process formal engineering change requests (ECRs) and engineering change orders (ECOs) more efficiently with automated approval routings. Team members can also document the full history of product changes, which is critical to address internal or external audits. 
  3. Regulatory Compliance
    To mitigate compliance risks, QMS software should help you adhere to FDA, ISO, and other key industry regulations or standards. It should enable the implementation of closed-loop corrective and preventive action (CAPA) processes to speed resolution of issues and prevent future occurrences of nonconformance. QMS should also provide complete control and traceability of product and quality records including DMRs, DHFs, SOPs, and training records.
  4. Design Controls
    What are Design ControlsEffective QMS solutions should establish and track design control elements such as user needs, design inputs, design processes, and design outputs. This helps simplify your review, verification, and validation processes. More importantly, a QMS should help you demonstrate compliance with policies, procedures, and FDA Title 21 CFR Part 820 as you move from early design phases through commercialization.
  5. Requirements Management
    Requirements management helps teams ensure that their product development objectives are met during the course of a product lifecycle. The ability to link requirements to the product record enables organizations to manage and track issues, defects, and customer needs throughout the entire lifecycle and innovate more rapidly. Effective requirements management processes create tighter connections and better collaboration between the project team members, managers, suppliers, and other key stakeholders.
  6. Document Management
    To meet the demands of highly regulated environments, companies must be able to store, track, and manage all of the documentation associated with product and quality records. This includes product specifications, assembly instructions, SOPs, quality policies, and training records. Document management allows for the centralized storage of documentation, as well as the establishment of audit trails and revision control.
  7. Training Management
    Product companies must maintain an employee training program to demonstrate compliance with FDA, ISO, safety, internal procedures, and other regulatory standards. Having an efficient, automated system to create employee training plans, assign training records, and generate progress reports helps simplify audits and reduce compliance risks.
  8. Product-Centric Framework
    The key to introducing safe and effective products is maintaining a tight connection between all of your product design information, quality records, training plans, and audit processes.

Traditional document-centric approaches to managing quality records address only a subset of information necessary to comply with quality standards imposed by the FDA, ISO, and other regulatory bodies. Ultimately, they fail to manage the complete product record—only providing basic document management capabilities for SOPs and other files.

Quality Product BOM DiagramProduct-centric QMS software platforms, however, manage linked relationships between DMRs, DHFs, BOMs, individual components, approved manufacturer/supplier lists (AMLs/ASLs), documentation, product history, and any changes or quality issues. This enables full visibility and traceability throughout new product development and introduction and ensures regulatory compliance.

Key Benefits of Product-Centric QMS:

    • Ensures compliance to FDA, ISO, and other regulations
    • Establishes strong design controls
    • Provides closed-loop CAPA processes
    • Improves training record management
    • Controls DHFs, DMRs, SOPs, and key quality documents
    • Connects product and change processes
    • Drives faster product development and launches
    • Mitigates audit risks
    • Enhances supplier collaboration
    • Improves visibility, traceability, and business insights

Things to Consider When Implementing a QMS System

Consider these key questions when evaluating what it takes to implement a QMS software solution successfully.

  • Software Validation
    Does the QMS software vendor provide a software validation service to help you meet the installation qualification (IQ) and operational qualification (OQ) requirements set forth by the FDA? Will the vendor provide the necessary IQ and OQ documentation set with every software release to support an FDA audit or submittal?
  • Security
    Is the QMS solution designed with a multilayered security model to ensure that your intellectual property (IP) is always protected? Are there safeguards or access controls in place to further protect product information and privacy?
  • Disaster Recovery
    Is the QMS software designed with built-in redundancies to quickly recover from a wide range of system failures?
  • Implementation and Training
    What resources are required from the QMS vendor and your team to complete the software implementation? How much time is needed to configure, test, and go live? What is the QMS vendor’s approach to training? Is it a train-the-trainer approach, or will your key stakeholders need to participate in the initial onboarding process? Is training provided via live or recorded sessions?
  • Ongoing Customer Education and Support
    Do you have access to adequate support and educational resources (e.g., best-practice information) after go-live? Are live, dedicated support staff (e.g., customer success coaches, customer service representatives) available to answer your questions to help drive your successful adoption and expansion of the QMS platform?
  • Scalability
    Is the QMS platform designed to easily accommodate additional users, suppliers, and/or functionality as your company continues to grow and product processes evolve?
  • Total Cost of Ownership (TCO)
    Your TCO should include not only up-front software costs—but costs associated with ongoing maintenance. Determine if there are additional costs for annual maintenance and/or new software releases. If so, what is the estimated frequency of upgrades? Also identify any costs associated with training and customer support. SaaS platforms include customer support as part of the software subscription and there are no additional charges to take advantage of regular software enhancements.

QMS Resources


7 Principles of Product-Centric Quality Management

Audit Resilience in a Virtual World: A Practical Guide

How to Buy the Right Software

White Papers

How Strong Design Controls Simplify Compliance and Eliminate Audit Anxiety

FDA Software Validation: How Cloud QMS Reduces Costs and Resource Drains

Meeting Regulatory Compliance Requirements in Today’s Global Market

Best Practices

How to Classify Your Medical Device for FDA Approval

5 Tips to Pass Your FDA or ISO Audit with Confidence

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