Medical device manufacturers are confronted with numerous issues concerning quality and compliance. Compliance with UDI, eMDR ISO 13485:2016, MDSAP EU MDR, and other international regulations is required in a highly competitive market.
Being on top of medical device safety is difficult enough. Yet, new initiatives like the FDA’s Quality Metrics initiative push the industry towards a data-driven medical device system for quality control focused on outcomes. In highly-regulated industries such as life sciences and pharmaceuticals, regardless of maturity in quality or auditing readiness, quality management systems specific to the sector (QMS) are designed to manage the complex process of developing biotech, pharmaceutical, and medical device products.
Furthermore, with a medical QMS, life science companies can reduce paper-based quality systems, enhance product quality and safety, cut overall expenses, improve efficiency in operations, and unite and make processes, documentation, and communications.
That’s why we’ve made the top 5 Medical QMS Software tools on the market in 2022
Let’s get started.
Table of Contents
What is Medical QMS Software Tool?
Medical QMS Software automates and simplifies quality control throughout the entire development cycle based on established operational procedures.
Medical QMS provides users with the capability to set guidelines, procedures, protocols, and policies for ensuring that products comply with regulatory agencies’ requirements and the industry’s expectations. Medical QMS can also generate compliance reports, schedule or automate inspections, and monitor any defects. It could contribute to quality control by enforcing compliance, identifying and fixing issues, and analyzing the product’s performance and specifications throughout every stage of development.
As a result, Medical QMS reduces the work required for quality assurance tasks dedicated to testing, bug hunting, and design work. Apart from improving product quality, medical QMS also cuts down on time to service and delivery of products and enhances customers’ satisfaction.
Specific solutions available are designed for general-purpose manufacturing, while other solutions are specifically designed for particular manufacturing (e.g., biochemical and pharmaceutical companies).
The most popular Quality Management Software features are:
- Control of documents
- ISO requirement management
- Supplier management
- Access on-demand to industry experts
- Risk management
- Management of E-signature
- Digital conversion
- Customizable dashboards
- Management of complaints and concern reporting
- Material for training and onboarding
- The preparation of audits, as well as scheduling
- Mobile app access
That’s why we’ve made the top 5 medical QMS software tools on the market in 2022.
Let’s have a look.
Top 5 Medical QMS Software tools in 2022.
Here’s a list of the top 5 Medical QMS Software tools on the market in 2022. We’ll also list their top features, the most utilized features, and the full description of each one below.
Arena QMS
Our list begins with Arena QMS. Arena’s system for quality management focused on products (QMS) simplifies the process of developing and introducing new products (NPDI) by linking quality and process processes.
Arena assures compliance with quality standards and regulations, including FDA 21 CFR Part 820-Part 11 and ISO 13485. Arena QMS enhances quality processes’ visibility and traceability by monitoring them within the bill of materials (BOMs), SOPs, DMRs, DHFs, drawings, specifications, and training programs.
With Arena’s proven cloud-based solutions and internal teams of users, as well as external partners, can benefit from the most extensive product development platform to speed up the pace of the launch of new products while cutting costs while increasing profits, and speeding the process of launch.
This helps accelerate new product development (NPD) and the recent introduction of products (NPI) by streamlining procedures, automating review cycles, and reducing mistakes to improve profits.
Arena recognizes that modern companies depend on teams distributed across the globe and supply chains to create products, maintain that they comply with regulations (FDA, ISO, ITAR, EAR, and environmental compliance), and meet customers’ needs.
- Deployment – Cloud, SaaS, Web-Based.
- Top Features – Defect Tracking, Document Coding & Control, ISO Standards Management, Risk Management, Supplier Quality Control, Training Management, Audit Management, Complaint Management, Compliance Management, Corrective and Preventive Actions (CAPA).
- Free Trial Available
- Prize – Price not provided by the vendor.
- Best for – Quality Management Software, API Access Controls/Permissions Activity Dashboard.
- Support – Email/Help Desk, Knowledge Base, Phone Support, Chat.
- Overall Rating – 5/5 Stars
Intellect
The second that comes on the list is Intellect. Intellect’s QMS software improves the quality of operations while reducing the overall cost of quality by 40\%.
Certified quality specialists develop the apps. They are easily customizable to our platform that does not require code and drag-and-drop technologies to meet your specific business requirements.
Users can provide their teams with the ability to access remotely via mobile applications with dynamic workflow, reports, and analytics with advanced and straightforward software. Applications include Document Control and Employee Training, Audit Management, CAPA, Nonconformance, and many more.
Intellect is the most customizable and easy for users to utilize business Quality Management System (eQMS) software suite and no-code platform to support business automation and process management.
Reduce your overall cost of ownership, cut down on recalls of products, and enhance efficiency by swiftly altering your top-quality applications or creating entirely new business applications that precisely meet users’ needs using the Intellect No-Code Platform.
- Deployment – Cloud, SaaS, Web-Based.
- Platform – Windows, Mac, Linux, Android, iPhone, iPad.
- Top Features – FDA Compliance, File Conversion, File Recovery, For Engineering Documents, Forms Management, Full-Text Search, Government Contracts, Graphical Workflow Editor, HIPAA Compliant, Incident Management, Instrument Management, Internal Controls Management, ISO Compliance, ISO Standards Management, Issue Management, Maintenance Management, Mobile Access, Sell-Side (Customers) Specialty, Contracts Supplier, Quality Control, Surveys & Feedback, Task Management, Templates.
- Free Trial Available
- Prize – Price not provided by the vendor.
- Best for – Quality Management Software, Audit Software, Business Process Management Software, Calibration Management Software, Compliance Software, Contract Management Software, Corrective and Preventive Action Software, Document Control Software, Document Management Software, Document Version Control Software, EHS Management Software.
- Support – Email/Help Desk, FAQs/Forum, Knowledge Base, Phone Support, 24/7 (Live Rep), Chat.
- Overall Rating – 4.8/5 Stars
Orcanos
Orcanos is third on the list. Orcanos is a Compliance Management SaaS that covers Design Control (ALM), Quality Management (eQMS), Manufacturing Execution Quality Control systems (MES) which are linked to each other with the with each.
They’re quick and straightforward for life science businesses (medical devices, pharmaceuticals, aerospace, and defense) that develop, manufacture, and market life-saving products and services.
Orcano’s collaborative environment has been proven to accelerate customer service by reducing overall costs of failure and risk and significantly improving service quality.
- Deployment – Cloud, SaaS, Web-Based.
- Top Features – API, Access Controls/Permissions, Activity Dashboard, Activity Tracking, Administrator Level Control, Alerts/Escalation, Alerts/Notifications, Approval Process Control, Archiving & Retention, Assessment Management, Audit Management, Audit Trail, Automated Routing, Baseline Manager, Bug Tracking, Change Management, Collaboration Tools, Communications Management, Complaint Management, Compliance Management, Compliance Tracking, Conflict Tracking, Controls Audit Corrective, and Preventive Actions (CAPA), Data Visualization.
- Free Trial Available
- Prize – Price not provided by the vendor.
- Best for – Quality Management Software, API, Access Controls/Permissions, Activity Dashboard, Activity Tracking, Alerts / Escalation, Alerts/Notifications, Approval Process Control.
- Support – Email/Help Desk, FAQs/Forum, Knowledge Base, Phone Support.
- Overall Rating – 4.7/5 Stars
Qualio
Qualio is the most efficient method for companies operating in Healthcare & Life Sciences to control Quality and Compliance. The software is considered the easiest to use QMS and the fastest CAPA and compliance software in the industry for Medical devices, Pharma, and Biotech firms.
It allows users to be five times quicker than paper or conventional solutions for document Control Training, NCRs, CAPAs, Audits, etc. Complaints, Suppliers, and more.
Create documents with automated numbering and simple linking of content that is related, record approbations with digital signatures, and then automatically notify users of documents that have been approved.
- Deployment – Cloud, SaaS, Web-Based.
- Top Features – ISO Standards Management, Issue Management, Maintenance Management, Nonconformance Tracking, Periodic Review, Quality Control Risk Assessment, Risk Management, Supplier Quality, Control Task Management, Training Management, Version Control, Workflow Management, Change Management, Complaint Management, Compliance Management, Compliance Tracking, Controls Audit, Corrective and Preventive Actions (CAPA), Dashboard Defect, Tracking Document, Coding & Control, Electronic Signature.
- Free Trial Available
- Prize – Price not provided by the vendor.
- Best for – Quality Management Software, Audit Software, Compliance Software, Corrective and Preventive Action Software, Document Control Software
- Support – Email/Help Desk, FAQs/Forum, Knowledge Base, Phone Support, 24/7 (Live Rep), Chat.
- Overall Rating – 4.4/5 Stars
ComplianceQuest
ComplianceQuest is a new-generation, adaptable Quality Management System (QMS) built on Salesforce to assist manufacturing and life sciences companies accelerate the process and product development, reducing risk and enabling constant improvement.
Additionally, users will access the complete and fully-integrable Health, Safety, Quality, and Environment solution by selecting the most appropriate modules for their specific needs.
It also comes with a package that helps streamline compliance, quality, safety content, and collaboration strategies and management initiatives across various global networks of supply chains.
- Deployment – Cloud, SaaS, Web-Based.
- Platform – Windows, Mac, Android, iPhone, iPad.
- Top Features – Issue Tracking Maintenance Management, Occupational Health Management, OSHA Recordkeeping, Periodic Review, Quality Assurance, Reporting/Analytics, Risk Management, Self Service Portal, Social Media Monitoring, Supplier Quality Control, Survey/Poll Management, Training Management, Version Control, Change Management.
- Prize – $30/Per Month.
- Best for – Quality Management Software, Safety Management Software Compliance, Quest Alternat, Complaint Management Software, Document Control Software, EHS Management Software
- Support – Email/Help Desk, Knowledge Base, Phone Support, 24/7 (Live Rep), Chat.
- Overall Rating – 4.7/5 Stars
Conclusion
At this point, you ought to have a clear understanding of the fundamentals of what you’re looking for. Each of the software listed is created to aid you in continuous improvement in your processes and ensure compliance for a clear audit trail.
A life sciences company does not have to settle for a QMS made for use in manufacturing facilities, a solution over the budget, or an extensive configuration application.
Once you’ve come up with the list of software options within your budget and your company’s needs as a client, ensure that the prospective vendor complies with FDA, ISO, and GxP specifications. Find out how the solutions can improve efficiency in your current business and scale to meet your requirements.
Check with them to determine if the software is compatible with your current plan and budget. This will let you know which software is best for your requirements. This article will provide the necessary information to choose the right software to meet your needs.
If you are looking at finding more such software, visit SaaSworthy
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