For enterprise organizations, enterprise quality management software (eQMS) is now the status quo. According to a recent market survey by LNS research, the software industry is experiencing 27% year-over-year growth as organizations in highly regulated industries adopt new applications and solutions for total quality management. The right eQMS software can offer bottom line-boosting benefits for the entire organization, including consistent product quality, minimized errors, improved customer satisfaction, and better brand valuation.
NOTE: The term "enterprise quality management software" has been mostly replaced by "electronic quality management software" over the last few years, though you see both terms used and they generally refer to the same thing.
While it’s clear that eQMS can be a high-value investment, not every enterprise quality management software is built the same way. There are 550 software vendors and products within the quality management category, which range from lightweight solutions for startups to robust, premises-based software for Fortune 500 enterprises. How do you even know where to start a search for the right system for your organization?
The right eQMS for your organization depends on your company and your firmographics, including size, industry, stage, and budget. Certain features are standard among the best eQMS for highly regulated sectors, and we'll cover them below.
What Is Enterprise Quality Management Software?
Quality Management Software (eQMS) is a category of enterprise technology which is designed to support the implementation of a formal system for quality management by managing documents and processes throughout the organization.
Organizations in highly regulated industries adopt eQMS to simplify compliance, risk management, data handling, and integrated complaint management into business processes and workflows. eQMS may be deployed as a cloud-based solution or legacy software, and consist of a series of integrated modules or an all-in-one application which integrates with the enterprise technology stack.
The specific features and capabilities of the best eQMS systems can vary depending on an organization's industry, size, and growth stages. However, several core capabilities are generally true of most eQMS systems. According to AssurX research, the five pillars of modern eQMS are:
- Integrated processes
- System flexibility
- Monitoring & management
- A culture of quality
As your organization seeks out the right solution, any system you evaluate should meet these core capabilities. To unlock the potential benefits of eQMS adoption, consider whether systems can offer value immediately post-implementation by fast-tracking out-of-the-box solutions. Other important considerations include the ability to integrate critical processes, flexibility, reporting, and compliance.
For an in-depth look at eQMS features, check out QMS Software: 7 Features That Save You Time, Money, and Resources.
1. Company-Specific Solutions
The right quality management solution for your organization is one which provides value out-of-the-box. Look for software built for your industry, company size, and growth goals. Prioritize solutions which can have a measurable impact on a quality-driven culture. According to Quality Digest, “an effective quality management system is put in place procedurally, is in use behaviorally, and is in control measurably.” As you seek solutions, consider how well prospective vendors and software fit with your processes, people, and reporting needs.
A solution which provides value out-of-the-box should deliver impact across procedures, culture, and reporting post-implementation, without a need for extensive configuration:
- Process Alignment: Compliant SOPs, operations, and training.
- Behavioral Alignment: Employees understand quality processes, SOPs are available at the point of use, records are accurate, and data is secure.
- Reporting Alignment: Visibility into performance, risk, correction, communication, and improvement.
2. The Ability To Integrate Processes
Process flexibility is a critical function for an eQMS at any organization, especially organizations which are scaling quickly. As your organization approaches market approval, your eQMS will need to scale from pre-market capabilities such as document management and training to new features and workflows, including CAPA. The key to effective process integration is understanding the difference between “configuration” and “customization” with enterprise systems.
A customized system will contain extensive code to integrate systems and processes which is written exclusively for your business, which sounds great in theory but isn’t always the most practical option. Each time a system update is required, including a security patch, you’ll be required to either write new code using in-house development resources or pay per hour for custom support. Custom-built integrations can be difficult, time-consuming, and expensive to maintain.
Unless your organization has the development talent on staff to create seamless custom integrations, your solution needs to contain the options to integrate processes and systems out-of-the-box by either acting as an all-in-one solution or offering built-in integrations between eQMS modules. Core process integrations should include:
- Automated quality
- Audits and reporting
- Compliance and risk management
- Document management
Depending on your organization’s needs, you may wish to choose a system which offers built-in integration with supporting software applications, such as Microsoft Office 365 or Google Drive, or your enterprise resources planning (ERP) application.
3. Flexible And Expandable
How flexible and expandable should your system be? It should fit your existing processes and offer the flexibility to scale and change as your organization grows and your processes improve. Unless you have a strong use case for a highly customized implementation, it’s likely valuable to fast-track vendors who offer built-in best practices for your industry and simple validation. Too much customization can create costly issues around implementation, validation and revalidation, and long-term system maintenance.
Flexibility is a measure of how much value you can derive out-of-the-box, and how effectively and quickly the system can change over time. If your organization adds new capabilities, such as CAPA or audits, can the system be updated easily by adding new modules, or will an upgrade require costly custom coding? If your organization has well-established quality processes in place, are you forced to adapt your workflows to fit a rigid software or pay for customization? An effective eQMS should meet your needs and offer flexibility to change in real-time as your business expands.
A final measure of flexibility is whether internal subject matter experts, such as the Quality Unit, can make simple changes to fit the system to your business without having to enlist the help of developers or technical experts. An eQMS should offer drag-and-drop editing capabilities for authorized internal users to update workflows, forms, templates, and checklists.
4. In-Depth Reporting Capabilities
Organizations in pharma, biologics, and medical device industries must consider how to meet strict regulatory requirements for reporting, including records keeping, audit trails, and access control over sensitive data. While these reporting capabilities are critical features of any eQMS system, it's vital to consider system "traceability" or whether the reporting capabilities are connected for the best business intelligence possible.
If your organization updates an SOP, is it simple to retrieve prior document versions and review the edit history within the eQMS system? Does the system offer smart links between documents to minimize manual rework efforts, such as time-consuming updates to your quality guidelines? Will the software create an automated notification for individuals impacted by the SOP to create required training?
To achieve a culture of quality, information needs to move seamlessly throughout the quality management system. Once you've taken action, consider how an eQMS allows you to push data through your processes, create accurate reporting, and create change in your operations. Fully integrated, closed-loop reporting capabilities can generate real business value.
5. Meets Compliance Standards
Every organization in FDA-regulated industries needs to be ready to pass an external audit at any time. The time to begin thinking about compliance isn't when you're exiting the product development phase and approaching market approval. It's during the earliest stages of your business, particularly when you're evaluating solutions for an eQMS.
The right solution can simplify compliance from the moment of implementation by setting a strong groundwork for Part 11-compliant eSignatures, data handling, document management, and meeting other requirements such as training.
A system which doesn't control processes under FDA and ISO recommendations can be an enormous risk to your business, especially in competitive marketplaces. Paper-based processes can easily introduce data loss, and ad hoc technological approaches such as emailing documents or using cloud-based storage can create a risk of non-compliance with eSignatures or missing audit data.
An eQMS should simplify a risk-based approach to complying with all applicable regulations in your industry by incorporating the latest FDA, ISO, and related best practices. The right solution should take care of compliance and quality by offering built-in support for FDA 21 CFR Part 820, 21 CFR Part 11, ISO 13485, and ISO 14971. In addition to built-in support for compliance, consider whether your cloud vendor will offer frequent updates to keep your organization compliant with emerging regulatory changes over the system lifetime.
Shop For An eQMS Like Goldilocks
The enterprise quality management landscape is mature, so you should be able to find a solution which is "just right" for your organization. The right system for your organization is right-sized for your company's needs, budget, and growth goals, and ready to offer value out-of-the-box with a design built per industry best practices. Our eQMS, for instance, is a great fit for small to mid-sized life sciences companies.
An eQMS shouldn't be difficult to mold to your businesses processes. It also shouldn't be a blank slate which requires extensive configuration to begin driving value. The right system should create a culture of quality and transparency across processes, people, and data.