Quality management systems give enterprise customers the tools to methodically meet compliance requirements and provide quality services to customers without scrambling between multiple platforms. With QMS software, enterprises are able to manage all their quality management-based compliance documentation in a single solution. They can prepare for audits and organize supplier information.
Handling customer feedback and complaints also plays a role in quality management and assurance. To produce a product that customers love and benefit from, enterprises often need to collaborate with them in the product design and change process.
What is a quality management system?
A quality management system is a control center for enterprise processes that helps organizations meet industry expectations and standards, with the purpose of producing goods and services that are satisfactory to both customers and the industry. Quality management is most frequently used by industries that need to produce goods that must meet a certain standard. Examples include:
- The medical industry (FDA requirements for devices and drugs)
- The manufacturing industry (baseline product safety requirements)
- The automotive industry (features that vehicles are expected to have)
- The food and beverage industry (FDA requirements, ISO 22000, food safety management audits)
Quality management systems help businesses meet their regulatory requirements by breaking down each step of the compliance process and recording the level of completion for those steps. They also help organizations collaborate with their customers to find an acceptable level of quality in goods and services through practices like reviewing and approving product designs and providing feedback.
Common standards covered by QMS software
Most— if not all— companies that use quality management systems or software have at least one regulatory standard to which they must adhere. Some of the most common include:
- ISO 9000 and 9001, for quality management systemssystem and quality assurance guidelines.
- ISO 27001, for information security standards.
- ISO 13485, for medical devices and services to meet regulations.
- ISO 22000, for food safety management systems.
- Code of Federal Regulations (CFR) FDA Title 21, for pharmaceutical products and cosmetics.
Some standards, including ISO 9001 and 27001, have certifications that businesses can earn. These certifications might help raise a customer’s confidence in the company or even be one of the conditions on which a business agreement rests
Read more on TechnologyAdvice: 3 Ways to Plan Quality Management in Projects
What are the benefits of QMS software?
Quality management system software brings all procedural and regulatory requirements together so that both large and small enterprises can manage them in a single digital platform.
Businesses are able to prepare for audits, organize supplier information, and have the required documentation ready. Preparing for enterprise audits without a central digital platform can be a messy and painstaking process, but a QMS solution brings all necessary documentation into one interface.
QMS software alerts employees when they need to complete a compliance task and allows businesses to manage all their quality management-based compliance documentation in a single solution. It provides a storage location for documents that outline quality management and quality assurance processes.
QMS solutions also provide training or support to businesses as they use the platform, like informative videos, webinars, or technical fixes or improvements.
Also read: How Organizations Commit to Compliance
Best quality management system software comparison
| Supplier management | Risk management module | Environmental or health and safety features | Equipment calibration management | |
|---|---|---|---|---|
| Qualio | ✅ | ✅ | ❌ | ✅ |
| QT9 | ✅ | ✅ | ✅ | ✅ |
| Greenlight Guru | ✅ | ✅ | ❌ | ❌ |
| ComplianceQuest | ✅ | ✅ | ✅ | ✅ |
| MasterControl | ✅ | ✅ | ❌ | ✅ |
Qualio
Qualio is a management tool for small to medium businesses in the life sciences industry, specifically biotech, medical device, and clinical research companies. To keep companies’ audits easier and more organized, Qualio provides its customers with reports, including an assigned approver and the status of the report, and document filters. Qualio offers a checklist to help businesses streamline compliance with 21 CFR Part 11, so that organizations using digital signatures can track their adherence to the regulation.
Qualio provides supplier and audit management and change control features, so pharmaceutical businesses can have better control over their drugs and supplies and meet expectations from auditors.
Qualio serves the contract research industry, too: it reveals the percentage of progress made on training and audit processes. It also shows the status of every event assigned to that training task. For contract researchers, Qualio also allows users to create workflows that determine document management, like reviewing or retiring documents.
For corrective and preventative action (CAPA) and non-conformance management, Qualio has automated workflows for companies to record and manage incidents and events throughout the event lifecycle. It shows what percentage of events have been resolved, how many steps have been completed to resolve each event, and the risk level for each event.
Qualio+ is an add-on to the Qualio plan that allows companies to collaborate with quality assurance experts. Qualio+ also includes templates and documents for meeting ISO and FDA regulations.
Key Differentiators
- Highly reviewed customer support team
- Features specifically designed for pharmaceutical, medical device, biotechnology, and contract research organizations
- Automated workflows to handle CAPA and non-conformance management and reveal how many steps still need to be taken to resolve issues
- Training management software with reports on overall training progress and training based specifically on role within the organization
Also read: Best Change Management Tools
QT9
QT9 is a quality management and enterprise resource planning (ERP) solution for businesses in manufacturing and other production-based industries, such as aerospace, food, and pharmaceuticals. Its many modules work together rather than being siloed, stand-alone applications. QT9 has both supplier and customer modules, allowing enterprises to evaluate their suppliers’ regulatory compliance and receive services and product feedback from clients.
The calibration management module allows businesses to create a schedule for calibrating each piece of equipment; when a piece of equipment needs to be calibrated, QT9 sends email reminders. This module helps manufacturing firms comply with ISO 45001, a safety standard that includes equipment calibration.
QT9’s engineering change order software, also known as engineering change request (ECR) or engineering change notice (ECN), allows businesses to manage their product design changes, such as sending email alerts when a design is edited or receiving input from clients. Engineering admins can assign approvers and verify or reject engineering change requests (ECRs). QT9 also gives companies a web portal where their customers can sign ECRs. Approvals in QT9 are done through electronic signatures.
QT9 also has a document control module, which received praise from customers—they found that the module streamlined their documentation and made content easy to search. QT9 users are able to remotely edit documents and share them with suppliers and clients.
QT9’s ERP software sets it apart from other QMS tools. For businesses that want their quality management processes and resource data in the same platform, the ERP solution includes bill of materials software that helps businesses track all items needed for a product. It also allows them to store multiple revised versions of products in the system.
Key Differentiators
- Engineering change order module that allows customers to be involved in the ECR process
- Calibration management module for equipment measurement and safety
- ERP software for industries like aerospace, food and beverage, and pharmaceuticals
- Documentation tool for collaborating with customers and suppliers
Also read: Best ERP Systems
Greenlight Guru
Greenlight Guru is a quality management solution specifically tailored for businesses in the medical field. Medical organizations use Greenlight Guru to achieve ISO 13485 certification, a process that reviews whether a company’s medical devices meet the quality standards set by ISO. Greenlight Guru also provides resources, like a webinar covering ISO standard changes or medical device product deployment guides, to enterprises.
The design control software within the QMS solution includes digital design reviews to help businesses plan product reviews. Additionally, the closed-loop traceability feature (also known as closed-loop quality management) improves visualization for companies that need to quickly provide documents to auditors or track the impact of changes.
Greenlight Guru is designed for businesses in the medical device industry, particularly smaller firms. For organizations wanting to use their QMS dually as a documentation tool, though, Greenlight Guru may not be the right choice. One of the major categories of complaints from customers was about the tool’s document management features. Users had trouble uploading documents from other applications and using the internal search feature to easily locate documents.
Greenlight Guru receives consistently high praise from users for its customer support team. Each business has the option to meet regularly with “gurus” for one-hour sessions to receive coaching, prepare for audits, or discuss risk management.
Key Differentiators
- Assistance meeting requirements for ISO 13485 certification
- Design control software for visualization, with closed-loop traceability to manage important business files
- Integration with Jira for design control in product development
- Responsive and helpful support team that received consistently positive reviews from customers
ComplianceQuest
ComplianceQuest is cloud-based QMS, environmental health and safety, and compliance management software built on Salesforce’s platform. It has a wide range of features that are useful for companies in many industries. Reviewers came from organizations in IT, apparel, warehousing, logistics, and transportation, to name only a few.
A unique feature of ComplianceQuest is its focus on sustainability and environmental health. The environment management solution helps businesses comply with EPA and other national regulatory standards. The solution also works with ComplianceQuest’s QMS software so companies can manage sustainability-related documentation and inspections.
ComplianceQuest also offers clinical trial management for medical and research companies. Features include patient recruitment, with campaigns and subject enrollment, and an investigator portal, which allows people participating in clinical studies to collaborate.
Because ComplianceQuest sits atop the Salesforce platform, businesses that already use Salesforce may find it easier to implement than companies that don’t use it, since they’re already familiar with the cloud-based Salesforce web application. Although ComplianceQuest markets its software as clinical, health and safety, and quality management-focused, it also meets the compliance and audit management needs of businesses in many different industries.
ComplianceQuest can even serve as a risk management tool. It has a risk management module and includes features like risk assessments, which can analyze the risks in QMS features like CAPAs and nonconformances. ComplianceQuest has an audit management module as well, which allows businesses to schedule all their audits and view past audit reports. For small and mid-sized organizations that want QMS software with risk management included, ComplianceQuest offers an interconnected suite.
Key Differentiators
- Risk management solution with risk assessments
- Environment management solution with sustainability reporting, permit management, and notices of violation
- Health and safety incident management reporting
- Clinical trial management with investigator collaboration and patient recruitment features
Also read: Best Risk Management Software
MasterControl
MasterControl is a quality management, manufacturing, and regulatory compliance platform. Its manufacturing solution is thorough, offering device history records and equipment calibration. Variant management software allows enterprises to track product variations; if a parent product is changed, the product variants underneath it change accordingly.
The change control solution reveals relationships between changes and other parts of the business and tracks changes that users have made. MasterControl’s change solution includes engineering change management for safety concerns and missing parts.
MasterControl’s document management solution helps businesses be 21 CFR Part 11 compliant by storing all documents and time-stamping them for audit purposes. External users, such as customers that need to view and approve a plan, can also receive access to a document.
MasterControl’s risk management software, part of the quality management solution, permits risk assessments throughout the rest of the platform. It also has a risk management database to store risk data, that the enterprise can analyze and use to handle threats.
The supplier solution also includes vendor management, which is an important component of risk management. MasterControl’s vendor management software stores supplier deviation records and bills of materials.
MasterControl’s suite of tools can serve smaller organizations that want to purchase limited software or large enterprises that want multiple advanced solutions that work together.
Consider whether your business has sufficient time and personnel to take time to implement it. Some customers found the navigation difficult or said that learning MasterControl’s software had a learning curve.
Key Differentiators
- Extensive products for manufacturers, including product variant management and equipment calibration
- Risk management software
- Assistance managing suppliers with bill of materials and vendor management tools
- Document management for 21 CFR Part 11 compliance
Important features in QMS software
Quality management systems often include the following features:
- Supplier or third-party management. Ensuring that third parties meet your expectations — and regulatory requirements — is a key part of business quality management.
- Risk management. Many QMS solutions include basic risk management features, like risk assessments, to help enterprises handle threats inherent in business operations.
- Document management. Documentation makes company policies and procedures readily available to all users of QMS software, allowing them to cross-check data and processes.
- Change control. A change management tool keeps changes and adjustments documented and helps businesses share those change records with employees.
- Audit management. QMS software assists businesses as they prepare audit documentation and work to keep track of all the data they’ll need for internal and external audits.
How to choose QMS software
If you’re planning to purchase quality management system software, consider the following things.
Quality management systems typically cater to similar industries, but not all QMS software has the same ideal customer. If you’re a large manufacturer and need specific built-in features like engineering change requests, look for solutions that have a manufacturing focus.
QMS software differs in ease of implementation. If you have a large team that can dedicate itself to a deployment process, implementing a solution-heavy platform with lots of modules (like MasterControl or ComplianceQuest) may be more doable for your business.
Look at vendor reviews to discern how responsive their customer support teams are, and determine how important that is to your business, especially depending on the size of your team.
Some QMS vendors support more regulations than ISO or FDA. Choose a quality management system depending on which regulatory standards your business must meet.
Enterprise quality management software is a powerful tool for organizing your business’s approach to regulatory compliance, managing supplier relationships, and maintaining customer trust. Carefully choosing a QMS solution is worthwhile for companies that want to use the software for many years and business transitions to come.
