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Quality Management


Quality Management software automates the process of tracking and minimizing product defects.


Heatmap for key functionalities

has certain core functions which are essential for this category of products

  • 1. Language Support


    Language support

    Key Features:

  • 2. Communication Channels


    Ways customers can contact service providers

    Key Features:

  • 3. Customer Service & Support


    Customer support services offered by vendor like 24/7 support, professional services etc.

    Key Features:

  • 4. Reports & Analytics


    Dashboard, metrics, analytics, export data to csv/pdf

    Key Features:

  • 5. Systems Operations


    Security, Authentication, Authorization, SSL, Data Privacy, Data Encryption, Data Centers, Permissions, Cloud Opertion

    Key Features:

  • 6. Regulatory Compliance


    GDPR, Privacy, Regulatory Compliance, Standard Operating Procedures

    Key Features:

  • 7. Digital Platform


    Integrations, Mobile Apps, iOS, Android, API, Add-ons

    Key Features:

  • 8. Identity and Access Management


    User Access Management, Authentication and Authorization

    Key Features:

  • 9. Security Management


    Electronic Signature, Acess Management, Data Encryption, Disaster Recovery, Two-step verification

    Key Features:

  • 10. Application Integration


    Data Import/Export, API, Platform Integration, Mobile Apps, Web App

    Key Features:

  • 11. Project Management


    Project management is the process of leading the work of a team to achieve goals and meet success criteria at a specified time. The primary challenge of project management is to achieve all of the project goals within the given constraints. This information is usually described in project documentation, created at the beginning of the development process. The primary constraints are scope, time, budget. The secondary challenge is to optimize the allocation of necessary inputs and apply them to meet pre-defined objectives.

    Key Features:

  • 12. Customer Relationship Management


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  • 13. Change Management


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  • 14. Incident Management


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  • 15. Contract Management


    Contract management or contract administration is the management of contracts made with customers, vendors, partners, or employees. Contract management includes negotiating the terms and conditions in contracts and ensuring compliance with the terms and conditions, as well as documenting and agreeing on any changes or amendments that may arise during its implementation or execution. It can be summarized as the process of systematically and efficiently managing contract creation, execution, and analysis for the purpose of maximizing financial and operational performance and minimizing risk.

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  • 16. Change Control Management


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  • 17. Complaint Management


    Consumer complaints are usually informal complaints directly addressed to a company or public service provider, and most consumers manage to resolve problems with products and services but it sometimes requires persistence. An instrumental complaint is a complaint made to a person or organization that could take some action and bring about a specific remedy. An expressive complaint is a complaint made for the purpose of expressing feelings, without any realistic chance of anything being done. Most online complaints are expressive complaints.

    Key Features:

  • 18. Document Management


    A document management system (DMS) is a system used to receive, track, manage and store documents and reduce paper. Most are capable of keeping a record of the various versions created and modified by different users (history tracking). In the case of the management of digital documents such systems are based on computer programs. The term has some overlap with the concepts of content management systems. It is often viewed as a component of enterprise content management (ECM) systems and related to digital asset management, document imaging, workflow systems and records management systems

    Key Features:

  • 19. EHS Management


    Key Features:

  • 20. Audit Management


    Key Features:

  • 21. Product Registration Management


    Key Features:

  • 22. Training Management


    Key Features:

  • 23. Supplier Quality Management


    Key Features:

  • 24. Quality Risk Management


    Key Features:

  • 25. Quality Process Management


    Key Features:

  • 26. Design Control Management


    Design Control Management

    Key Features:

  • 27. Compliance Management


    Compliance Management

    Key Features:

  • 28. CAPA Management


    CAPA Management

    Key Features:

  • 29. Nonconformance Management


    Nonconformance Management

    Key Features:

  • 30. Calibration Management


    Calibration Management

    Key Features:

  • 31. Preventive Maintenance


    Preventive Maintenance

    Key Features:

  • 32. Inspection Management


    Inspection Management

    Key Features:

  • 33. Communication Management


    Communication Management

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  • 34. Meetings Management


    Meetings Management

    Key Features:

  • 35. Permits Management


    Permits Management

    Key Features:

  • 36. Maintenance Management


    Maintenance Management

    Key Features:

  • 37. Safety Management


    Safety Management

    Key Features:

  • 38. Contractor Management


    Contractor Management

    Key Features:

  • 39. Equipment Management


    Equipment Management

    Key Features:

  • 40. Sustainability Management


    Sustainability Management

    Key Features:

  • 41. Survey Management


    Survey Management

    Key Features:

Top Products


Medical Device QMS Software

Medical Device QMS Software

Greenlight Guru is the only electronic Quality Management Software (eQMS) designed by MEDICAL DEVICE PROFESSIONALS specifically to meet the unique NEEDS OF MEDICAL DEVICE COMPANIES. Our comprehensive, out-of-the-box solution is based on the latest FDA and ISO standards and best practices, all of which are meticulously woven into every feature within the cloud-based platform. Join hundreds of other medical device companies working with us to shift your focus from just compliance to True Quality.

MasterControl Quality Excellence

MasterControl Quality Excellence

MasterControl Quality Excellence solutions are used by five of the largest regulatory agencies in the United States. A leading software-as-a-service (SaaS) provider, MasterControl helps companies get their life-improving products to market sooner. It does this by providing cloud-based solutions that manage an organization's documents, training and exams, corrective/preventive action, validation, and more. And it's not just quality, MasterControl has solutions for the entire product lifecycle.

Donesafe

Donesafe

Donesafe is a Quality Management software that connects your system from workers in the field to the management team in the boardroom. Donesafe makes it fast and easy to access, enter and report QMS data in real time. Donesafe is a modern & fresh platform with end to end functionality. It works online with any device, including offline with native iOS and Android apps. Use our out-of-the-box templates or configure to align with your specific requirements. Try now.

Adaptive Compliance Engine (ACE)

Adaptive Compliance Engine (ACE)

ACE is an intuitive, single-platform, quality management software solution trusted by large and small companies alike. We stand apart due to our easy to learn user interface, straightforward pricing, and cutting edge analytic and visualization platform. ACE is fully configurable allowing the COMPANY to adapt ACE to fit the companys exact quality needs. Contact us today to learn how ACE can improve compliance and streamline quality across your enterprise. 21CFR Part 11 compliant.

ZenQMS

ZenQMS

Is your life sciences compliance profile hampered by homegrown tools like physical paper and spreadsheets? ZenQms offers a part 11 compliant system that can help you manage documents, CAPA's, training records, and more. With extremely affordable solutions, unlimited seats and setup time measured in days we help you dramatically improve your quality compliance profile

Qualio

Qualio

The simple, fast, and scalable quality management platform for young and growing Medical Device, Pharma, and Biotech companies. Get a demo to see why hundreds of FDA, ISO, and GxP regulated companies trust Qualio to bring their quality team, tools, and data together in one place. Well convert your manual, paper-based system to our easy-to-use platform for free. "It's amazing how it all just works." - ROWA Pharma. Get a personalized demo today!

Q-Pulse

Q-Pulse

Q-Pulse offer a risk-based approach to Quality & Document Management, which can help organisations comply with industry specific standards and regulations. Our user friendly software provides a central focal point for all relevant documentation, data, materials and activities associated with the quality process. Modules include: Document Control, Risk Management, CAPA Management, Audit and Findings, Reporting, Staff Competency and Development & Vendor Management.

RizePoint

RizePoint

Purpose-built for quality managers, RizePoint's quality management software empowers you to collect and analyze meaningful data so you can gain visibility, drive improvement, and keep brand promises. You'll gather better data, see more with intelligent analytics, and spot trends so you act faster when issues arise.

Gensuite

Gensuite

Integrating Gensuite Quality Management software into your workplace equips your team with the tools necessary to meet expectations and deliver the quality that your customers expect. Record non-conformities/defects and initiate follow-up, engage your team through concern reports, perform root cause analyses to identify issues and continuously improve, and more. Boost quality standards, meet compliance requirements & exceed customer expectations

QCBD

QCBD

The AFFORDABLE SOLUTION for small to mid-size companies. Designed specifically for MANUFACTURING companies, Quality Collaboration By Design (QCBD) is an integrated Quality Management Software for managing all your quality data. QCBD dramatically reduces the cost of achieving and maintaining compliance to quality management standards such as ISO 9001, ISO 13485, AS9100, TS 16949 and SQF 2000 / ISO 22000. Window-based application (client-server, not a web application)

Quality Management Software

Quality Management Software

uniPoint is leading-edge Quality and Compliance Management software for the medical device, aerospace, automotive or general manufacturer. With over 40 standard integrations, we are the industry leader in ERP-Integrated Quality Management Software. uniPoint manage Non-Conformances; Corrective/Preventative Actions; Document Control; Tooling & Equipment Mgmt; Customer Service; Requests/Change Mgmt, Auditing, Education & Training; Health & Safety, Surveys, Inspections, Supplier Mgmt & Risk Mgmt.

Cority

Cority

Cority is the most trusted EHSQ software for assuring client success. Cority's comprehensive SaaS platform helps organizations securely manage EHSQ information across departments, regions and the globe. Over 1200 organizations in 70 countries trust Cority to ensure global compliance, mitigate risk, standardize procedures, drive operational excellence and keep employees safe, healthy and productive.

QT9 Quality Management

QT9 Quality Management

Quality management software made easy. Seamlessly connect quality processes together and automate ISO & FDA compliance with QT9's web-based solution. QT9 QMS includes interconnected modules for Document Control, CAPA's, Audits, Risk Assessments, Customer Complaints, Calibration Management, Supplier Management & more. Your all-in-one cloud QMS solution puts time-consuming tasks on autopilot. Improve collaboration. Modernize quality control, centralize records & easily work from home. Great value.

isoTracker Quality Management

isoTracker Quality Management

Cloud-based QMS software that's ideal for small to medium-sized businesses, with separate modules for document control, complaints management, auditing, non-conformance management, and training. The software features built-in corrective and preventive action (CAPA) capabilities. Designed for easy compliance with ISO 9001 and other QM standards.

Intellect

Intellect

Intellect's Quality Suite is a software solution proven to enhance quality operations and reduce overall quality costs by 40%. Our applications are designed by certified quality experts and can easily be tailored with no code, drag and drop technology to fit your exact business needs. With automated workflow functionality you are now enabled to decrease time spent on manually consuming tasks. Apps include Document Control, Employee Training, Audit Management, CAPA, and Nonconformance.

Quality Management Software

Quality Management Software

With over 1 million users worldwide, Intelex Quality Management Software applications have been helping companies around the world manage, track and report their quality metrics for over 20 years. Drive continuous improvement across all aspects of your quality program, reduce risk and ensure ISO 9001 compliance with this flexible set of user-friendly applications to manage Defects, NCRs, CAPAs, Suppliers, Customers, Complaints, Audits, Training, Documents, and much more. Try It Free Now!

Arena QMS

Arena QMS

Arena's product-centric quality management system (QMS) streamlines new product development and introduction (NPDI) by connecting quality and product processes. Arena ensures regulatory compliance to quality standards and regulations including FDA 21 CFR Part 820, Part 11 and ISO 13485. Arena QMS enhances visibility and traceability by controlling quality processes in context with bills of materials (BOMs), SOPs, DMRs, DHFs, specifications, drawings, and training plans. See ArenaSolutions.com.

Buyer's Guide


  • Greenlights Guru is designed specificially for the medical device industry based on their marketing claim. Let's explore what makes them unique in this category by looking at the functionalities offered by the product.

    Figure 1. demonstrates the functionality heat-map for Greenlight guru. The bigger the area of each box implies that that function has more feature coverage compared to other functions:

     

    Screen Shot 2021-02-19 at 12.19.05 PM.png

    Figure 1.

     

    Below are the 11 core capabilities of Greenlight Guru in the order of their strength based on their implementation in leading products:

    1. Design Control Management

    2. Audit Management

    3. Complaints Management
    4. Nonconformance Management

    5. Training Management

    6. Reports & Analytics

    7. Quality Risk Management

    8. Document Management

    9. Change Management

    10. Regulatory Compliance

    11. Quality Process Management

    12. CAPA Management

    13. Supplier Quality Management

    14. Compliance Management



    Let’s dive deeper into each of these capabilities:

    1. Design Control Management

    Design Control Management plays a very important role in QMS especially for device manufacturers because close to half of the voluntary recalls can be prevented by adequate design controls, most frequent causes for recalls are related to design, software, and non-conforming materials/components. Safe Medical Device Act of 1990 authorized FDA to add Design Controls to current Good Manufacturing Practice (cGMP) requirements for medical devices. All of these reasons make Design Control Management a key modudle which Greenlight Guru has made core to it's product offering.

    To meet capabilities for Design Control Management some of the key features implemented are:

    Design Review, JIRA integration, On-Demand Design History File Generation, Link to Artifacts, Automate Reports, Team Collaboration tools, Visiblity between Risk Management & Design Control, Multi-level Design Control, Visualization, Industry & Regulatory Standards etc.

     

    2. Audit Management


    Audit Management module contain functionalities to perform a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

    To meet capabilities for Audit Management some of the key features implemented are:

    Audit Readiness check, Alerts for key dates, Internal/External Audit, Data Harmonization, Workflow Management, Automation, Traceability & Auditability Matrix, View Critical Trends, Escalations, etc.

     

    3. Complaints Management


    Complaints Management module contains functionalities to effectively deal with customer complaints, identify opportunities for improvement of your processes, eliminate root cause of the complaints & stop problems from happening again, alert in early stages of complaints, avoiding escalations & problems & improve customer satisfaction etc.

    To meet capabilities for Compliants Management some of the key features implemented are:

    Streamline customer complaints, escalate, capture, ability to convert it to CAPA, attach documents, uncover patterns, assign customer feedback to related tasks etc.



    4. Noncoformance Management


    Noncoformance Management module contains functionalities to focus on prevention, streamline compliance, reduce cost of quality, reduce regulatory and product risk, automatic recognition nad reaction to noncoformance events such as deviations in processes, materials, and test results. They enforce strcutured failure analysis, root cause identification providing comprehensive data to rpovide early warnings and real-time visiblity into operations to repvent quality issues.



    To meet capabilities for Nonconformance Management some of the key features implemented are:
            
    Automate step-by-step processes, Custom workflows, Uncover patterns, Gain Visiblity into the relationships, Navigation and Drill-down into quality system, Contact Supplier with defective part etc.


    5. Training Management


    Training Management module contains functionalities to manage, monitor, and asses workfoce trianing requirements, ability to perform instructor-led or document-based training, centralize & manage all training initiatives, create relevant training requirements based on roles, complete visiblity into training performance.

    To meet capabilities for Training Management some of the key features implemented are:

    21 CFR Compliant Signature, Automated alerts, Complete Visiblity, Role-based training, Integration etc.


    6. Reports & Analytics


    Reports & analytics module contains functionalities like visualization, alerts, dashboards, visiblity to device design, drill-down, export to PDF/CSV format.

    To meet capabilities for Reports & Analytics some of the key features implemented are:

    Visualization, Streamline audit preparation, understand downstream impact of a change, drill-down, dashboards, alerts & notifcations etc.


    7. Quality Risk Management


    Quality Risk Management module contains functionalities to identify & evaluate risk based on scientific knowledge & ultimately link to the protection of subjects. Abitlity to view and mange risk controls for reduction and acceptance. 

    To meet capabilities for the Quality Risk Management some of the key features implemented are:

    Centralize workflow, ability to conduct risk analysis, risk evaluation, risk control process, link risk management to desing & development activities, integrate with Audit & inspection management etc.


    8. Document Management


    Document Management module contains functionalities to organize all your documents in single place. Built-in workflows and audit trails help eliminate redundancy. Seamless integration with quality management activies such as CAPA and training management, improve audit readiness.


    To meet capabilities for the Document Management feature, some implemented characteristics are:


    Electronic Signature, Part 11 compliance, Flexible Review & approval workflow, revision control, document access & visiblity based on user roles etc.


    9. Change Management


    Change Management module contains functionalities to define, modify, track and mange change in both external and internal process. It help  

    To meet the capabilities for Change Management some of the key features implemented are:

    Business hours, 24/7 Support, Email Support, Rate Support, Chat Support, Feedback, Detector, Surveys, Legal Assistance, Professional Services, Work hour Setting, Dedicated Account Manager, Customer Engagement, Field Suggester, Time zones, Multiple SLA, Out of office hours, Software Engineer Support, Toll-free, Advertising Billboards, Data Visualization, Appointments, Thank you detector, Non-business hours routing, Blab Support, Guest Users, Video, Hands-on Support, Gamification, After call work, Lifecycle


    10. Regulatory Compliance Management

    Regulatory Compliance Management contains functionalities to

    To meet capabilities for Customer Relationship Management (CRM) some of the key features implemented are:

    Resource booking for appointment scheduling in CRM, CRM forms, Business Project Automation in CRM, Leads, deals, contacts or companies directory, Quotes, Invoices, Sales Center, Sales Generator, Migrate from other CRM, Keyword Analysis, Kanban View, Recurring deals, Bulk email, Call Tracking, Convert leads to contact, company, deal, Convert quote to deal, invoice, Retargeting in ad network, Edit rules, triggers in business process designer, Convert deal to quote and invoice, Built-in telephony, Required fields by stage, Document Generator, Client Profile, Product catalog, Pipelines, Sales intelligence report, Email from CRM, Voice broadcasting, Conversion Tracking


    11. Quality Process Management


    Identity and Access Management (IAM) is a framework of policies and technologies for ensuring that users can be authenticated and authroized to use company resources.

    Why is this capability important to the Help Desk Application?
    As discussed previously, users are now not just outside the company network but are also using their own devices to access resources on the company network. This has led vendors to find solutions where they are not limited by one way of authenticating and authorizing users. The complexity of authenticating a user has increased so much that there are dedicated vendors who provide this service.

    To meet capabilities for Identity and Access Management (IAM) some of the key features implemented are:

    Roles, Teams, Authentication, Authorization, User Settings, Permissions, Provision, Notifications, Group Permissions, Unlock Account, Access Permissions, User Access, Customer Data Modification Permission Controls, Password reset, Separate users into multiple teams, Custom user permission roles, Viewer account, Configure Team Settings, Configure Team Rules, Team Contact Manager, CSV Import, Teammate templates, Departments (staff group), LDAP



    In conclusion, these twelve capabilities are the building blocks of a help desk software based on what the customers and vendors have agreed to in 2020.