[ MasterC... Reviews ](https://www.g2.com/products/mastercontrol-quality-management-system/reviews) [ MasterC... Reviews ](https://www.g2.com/products/mastercontrol-quality-management-system/reviews) # MasterControl Quality Management System Features ##### ## File Management (12) File Type Support Supports all required file types including but not limited to: Google Docs, MS Office, images, videos, etc. Metadata Automatically adds descriptive metadata like file size and upload date, has standard metadata fields like keywords, and allows the definition of custom fields and vocabulary. OCR Scanning Can structure unstructured data through Optical Character Recognition or other automated filing/tagging processes for scanned documents. Versioning Keep track of incrementally changing versions of the same file. Collaboration Multiple users can collaborate on document creation, annotation, and review. Document Assembly Autogenerate documents based on templates and form submission. Form Creation Able to create and manage submittable user forms. Portals and Sites Able to create user portals and sites. Disposition Automatically archive, delete, or revoke access to files that have reached the end of their life cycle. Search Can easily find files via a simple and/or advanced search. Web Interface Ability to access documents via a web interface without a client being installed on a device. Mobile Apps iOS, Android and Windows phone apps provide functionality that enable users to perform the same functions as they would on a PC. Show More ##### ## Workflow (5) Process Automation Specifying a series of conditions and actions can automate internal processes, is customizable to the complexities of organization's needs and easy to set up and execute. Conditions The workflow engine provides relevant and customizable conditions on which to execute rules. Activities Any action a user can perform in the system can be specified as an automated action. Records Management System provides the necessary tools and fuctionality to maintain evidence of business activites and comply with governmental requirements or industry standards. Case Management System provides specialized functionality for bundling structured and unstructured content, automating adaptive, multi-person processes and setting deadlines for open cases. Also, cases can be completed and closed with the associated information stored and auditable. Show More ##### ## Platform (9) Internationalization Allows organizations multi-national organizations to use tool effectively across multiple languages and currencies. Performance and Reliability Software is consistently available (up-time) and allows users to complete tasks quickly because they are not waiting for the software to respond to an action they took. Reporting and Auditing Access pre-built and custom reports to monitor user activity and storage. System of Record Integration Integrates with other systems of record such as CRM, ERP, Outlook, Sharepoint. APIs Enables custom integration to external systems. Integration Delivers APIs and standard integrations with other software systems. Security & Privacy Complies with security and privacy regulations and standards. Mobile Access Allows users to access the software using mobile devices. Flexibility Facilitates software configuration without the need for technical experise. Show More ##### ## Quality Management (4) Design Controls Ensures that the product development process stays on track and continues to meet both user and vendor needs Audit Management Prepares for, plans, manages, schedules, and conducts internal and external audits Supplier Network Management Connects suppliers with product developers with consumers Risk Management Reviews, identifies, and assesses sources of risk in research and development Show More ##### ## Quality System (4) Analytics & Reporting Collects both vendor- and customer-facing data relevant to the product development lifecycle, and generates performance and health reports Real-time Collaboration Enables real-time collaboration like automated notifications and rich editing and commenting capabilities to minimize miscommunication Document Control Automates, centralizes, and archives documents and forms to create a single source of truth Quality Processes Automates and manages processes like CAPA (Corrective and Preventive Action) to monitor quality and complaints and promote transparency Show More ##### ## Usability (3) All-Employee Access Permits use by job roles outside of service department Supporting Documents Allows linking of useful information such as screen shots Two-Way Communication Provides direct contact between CSRs and customers outside of milestones Show More ##### ## Reporting (3) Priority Case Alerts Informs stakeholders of activity on escalated or high-value cases Trend Analysis Evaluates frequency of types of complaints Performance Monitoring Includes a dashboard or other means of performance monitoring Show More ##### ## Nonconformance (3) Conformance Records Allows users to create, track and maintain accurate, auditable conformance records. CAPA Allows users to assign tasks for corrective and preventive actions (CAPA) to employees in nonconformance Change Management Allows users to submit change requests and control plan revisions at any point in the production process and track all revisions. Show More ##### ## Quality system (3) Document Control Allow users to centralize and archive documents for quality management Collaboration Allows users to collaborate in real time with editing and commenting capabilities to minimize miscommunication Analytics and Reports Allows users to collects both vendor- and customer-facing data relevant to the product development lifecycle, and generates performance and health reports Show More ##### ## Risk Management (3) Assessments Allows users to determine potential risks that may impact employees or the environment Operational Risk Allows users to estimate the impact of EHS risks on the operations of the company Supplier Evaluation Allows users to evaluate suppliers using safety and environmental criteria Show More ##### ## Inspection Management (3) Templates Allows users to choose from templates for multiple types of inspections such as safety or quality Workflows Provides users with workflows to assign tasks for audit and inspections Corrective Actions Allows users to identify corrective actions to address incidents and accidents Show More ##### ## Compliance (2) Permits Allows users to track permits required for environmental and safety compliance Certifications Allows users to manage certifications to comply with regulations and standards Show More ##### ## Services (4) Implementation Assists customes through all the phases of the implementation process. Training & Learning Provides software users with training courses and learning content. Customer Support Delivers customer and technical support, directly or trough partners. Professional Services The vendor provides consulting services such as business process reengineering. Show More ##### ## Regulatory Compliance (4) Dashboards and Reporting Offers customizable dashboards and analytics to track completeness, compliance, quality, and timeliness of the study. TMF Reference Models Offers a pre-built DIA TMF reference model hierarchy, and allows for configurable reference models to meet the specific needs of organizations and sponsors. Inspection Readiness Supports inspections and regulatory audits by maintaining inventory and document reports, and having pre-built compliance with all relevant regulatory guidelines. Role Permissions Designates customizable user roles and limit access to certain functions in the eTMF. Show More ##### ## Content Management (7) Bulk Upload and Indexing Allows users to upload multiple documents at once and provides dynamic indexing options. Document Tracking Manages the status of all trial documentation at all stages and flags missing documentation. Version Controlling Tracks each version of a document and shows changes from each version or reupload. Search Engine Allows documents and metadata to be easily searched within the system. File Planning and Milestones Establishes study level, country level, and site level milestones and what amount of mandatory and optional documents need to be collected throughout the study lifecycle. Real-Time Authoring and Collaboration Allows external or remote contributors to upload documents and work collaboratively in a controlled method. Content Workflows Configures review, e-signature, and approval workflows for all documentation. Show More ##### ## Document Management (4) Dossier Management Tracks submissions plans for products to report against milestones and progress. Streamlines the entire dossier lifecycle and tracks the status of all submissions. Tech Files Supports the creation of technical files and essential principles checklists. Submission Planning Provides templates and tools to create all planned regulatory content for a product. Archiving Stores all previously submitted documents for use in audits or future submissions. Show More ##### ## Product Management (5) Audit Trails Enables traceability into the entire pre- and post-market lifecycle to monitor milestones, time to completion, and updates and approvals. Label Management Prepares and submits labels and UDI submissions for products, validated accordingly to regional regulatory requirements. Live Dashboards Maintains up-to-date dashboards for overseeing every task, deadline, project status, and workflow. Collaborative Authoring Allows multiple users to collaborate on documents and flag errors or updates. Product Information Centralizes and tracks detailed product information, such as registration status and selling status for each location and market. Show More ##### ## Regulatory Affairs (4) Automated Notifications Tracks key deadlines for submissions, renewals, and audits, and streamlines the document retrieval process for each activity. Post-Market Surveillance Streamlines post-market product data collection and analysis for safety, sentiment, and future product improvements. Communication Tools Fields internal team and external agency messages or tickets related to regulatory concerns, and inboxes all correspondences. Regulatory Intelligence Connects to regulatory databases and market sources to monitor upcoming changes that may impact product selling status. Show More ##### ## Generative AI (6) AI Text Generation Allows users to generate text based on a text prompt. AI Text Summarization Condenses long documents or text into a brief summary. AI Text Generation Allows users to generate text based on a text prompt. AI Text Summarization Condenses long documents or text into a brief summary. AI Text Generation Allows users to generate text based on a text prompt. AI Tasks Automates basic tasks and workflows utilizing AI. Show More ##### ## Workflows - Audit Management (5) Audit Trail Displays all the changes made during audits, including details such as username, timestamp, or type of change in a centralized repository. Recommendations Coordinate and track recommended remediation actions. Collaboration Tools Facilitates collaboration between teams and stakeholders through shared workspaces. Integrations Integrates with risk management platforms, GRC tools, and other systems. Planning & Scheduling Facilitates the creation of audit plans, schedules, and reminders. Show More ##### ## Documentation - Audit Management (2) Templates & Forms Provide out of the box audit templates and forms for various processes and industries. Checklists Provides checklists Show More ##### ## Reporting & Analytics - Audit Management (3) Dashboard Dashboard provides real time or near real time updates and notifications in a centralized location. Audit Performance Provide information on the performance of the audit activities and processes. Industry Compliance Ensures audits are compliant with industry-specific regulations and standards. Show More ##### ## Monitoring - IT Risk Management (1) AI Monitoring Utillizes AI to monitor and report on incidents in real-time. Show More ##### ## Operational Risk Management (3) Operational Risk Methodology Support various methodologies and frameworks for operational risk management such as ISO 31000 and COSO. Operational Risk Classification Ability to classify risks based on risk type, severity, and custom criteria. Operational Risk Identification Identify various risk factors such as the inadequate use of technology, human factor, or external risks. Show More ##### ## Business Resilience (2) Business Continuity Support business continuity plans through integrations with business continuity software, incident response, or controls planning Compliance Management Reduce risk of legal liability through regulations and standards compliance. Show More ##### ## Agentic AI - IT Risk Management (2) Autonomous Task Execution Capability to perform complex tasks without constant human input Multi-step Planning Ability to break down and plan multi-step processes Show More ##### ## Agentic AI - Operational Risk Management (1) Proactive Assistance Anticipates needs and offers suggestions without prompting Show More ##### ## Agentic AI - Enterprise Content Management (ECM) (3) Autonomous Task Execution Capability to perform complex tasks without constant human input Natural Language Interaction Engages in human-like conversation for task delegation Decision Making Makes informed choices based on available data and objectives Show More ## Top-Rated Alternatives [ ![Qualio](https://images.g2crowd.com/uploads/product/hd_favicon/989edd615dfb84f85af09d42b2a45a5a/qualio.svg "Qualio") Qualio 4.4/5(778) ](https://www.g2.com/products/qualio/reviews) [ ![Octave Reliance (ETQ Reliance)](https://images.g2crowd.com/uploads/product/hd_favicon/5941a9432ebe44facaf9413366486f4d/octave-reliance-etq-reliance.svg "Octave Reliance (ETQ Reliance)") Octave Reliance (ETQ Reliance) 4.3/5(621) ](https://www.g2.com/products/octave-reliance-etq-reliance/reviews) [ ![Arena PLM & QMS](https://images.g2crowd.com/uploads/product/hd_favicon/08a5a9b57ded85f944279a72e01d11cb/arena-plm-qms.svg "Arena PLM & QMS") Arena PLM & QMS 4.2/5(463) ](https://www.g2.com/products/arena-plm-qms/reviews) [ View All Alternatives ](https://www.g2.com/products/mastercontrol-quality-management-system/competitors/alternatives) MasterControl Quality Management System Comparisons ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/small_square/small_square_239fdb020d69919db5553a9bf0b0e605/qualio.jpg "Product Avatar Image") Qualio 4.4/5(778) [ Compare Now ](https://www.g2.com/compare/mastercontrol-quality-management-system-vs-qualio) ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/small_square/small_square_8d010e85f26931023591b7c85251aa23/greenlight-guru-quality-management-system.png "Product Avatar Image") Greenlight Guru Quality... 4.5/5(411) [ Compare Now ](https://www.g2.com/compare/greenlight-guru-quality-management-system-vs-mastercontrol-quality-management-system) ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/small_square/small_square_60c9e8bac3ab1b560dc50c861471b629/honeywell-trackwise.png "Product Avatar Image") TrackWise Enterprise Quality Management Software 4.3/5(48) [ Compare Now ](https://www.g2.com/compare/mastercontrol-quality-management-system-vs-honeywell-trackwise) ##### Categories on G2 [ Complaint Management ](https://www.g2.com/categories/complaint-management)[ Audit Management ](https://www.g2.com/categories/audit-management)[ Enterprise Content Management (ECM) ](https://www.g2.com/categories/enterprise-content-management-ecm) [ IT Risk Management ](https://www.g2.com/categories/it-risk-management)[ Quality Management (QMS) ](https://www.g2.com/categories/quality-management-qms)[ Medical QMS ](https://www.g2.com/categories/medical-qms)[ Operational Risk Management ](https://www.g2.com/categories/operational-risk-management)[ Electronic Trial Master File (eTMF) ](https://www.g2.com/categories/electronic-trial-master-file-etmf)[ Regulatory Information Management (RIM) Systems ](https://www.g2.com/categories/regulatory-information-management-rim-systems) Show More ##### Explore More [ What content curation platforms offer reliable cross-platform aggregation for higher education and media companies? 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