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.
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.
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
Based on 227 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Delivers APIs and standard integrations with other software systems.
Security & Privacy
Based on 249 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Complies with security and privacy regulations and standards.
Mobile Access
Based on 228 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to access the software using mobile devices.
Flexibility
Based on 258 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Facilitates software configuration without the need for technical experise.
Quality Management (4)
Design Controls
As reported in 62 MasterControl Quality Management System reviews. 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 64 reviewers of MasterControl Quality Management System have provided feedback on this feature.
Supplier Network Management
Based on 60 MasterControl Quality Management System reviews. Connects suppliers with product developers with consumers
Risk Management
Reviews, identifies, and assesses sources of risk in research and development This feature was mentioned in 59 MasterControl Quality Management System reviews.
Quality System (4)
Analytics & Reporting
Collects both vendor- and customer-facing data relevant to the product development lifecycle, and generates performance and health reports This feature was mentioned in 62 MasterControl Quality Management System reviews.
Real-time Collaboration
As reported in 66 MasterControl Quality Management System reviews. Enables real-time collaboration like automated notifications and rich editing and commenting capabilities to minimize miscommunication
Document Control
As reported in 73 MasterControl Quality Management System reviews. Automates, centralizes, and archives documents and forms to create a single source of truth
Quality Processes
As reported in 68 MasterControl Quality Management System reviews. Automates and manages processes like CAPA (Corrective and Preventive Action) to monitor quality and complaints and promote transparency
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
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
Nonconformance (3)
Conformance Records
Based on 251 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to create, track and maintain accurate, auditable conformance records.
CAPA
Based on 263 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to assign tasks for corrective and preventive actions (CAPA) to employees in nonconformance
Change Management
Based on 259 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to submit change requests and control plan revisions at any point in the production process and track all revisions.
Quality system (3)
Document Control
Based on 289 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allow users to centralize and archive documents for quality management
Collaboration
Based on 285 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to collaborate in real time with editing and commenting capabilities to minimize miscommunication
Analytics and Reports
Based on 282 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to collects both vendor- and customer-facing data relevant to the product development lifecycle, and generates performance and health reports
Risk Management (3)
Assesments
Based on 238 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to determine potential risks that may impact employees or the environment
Operational Risk
Based on 233 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to estimate the impact of EHS risks on the operations of the company
Supplier Evaluation
Based on 231 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to evaluate suppliers using safety and environmental criteria
Inspection Management (3)
Templates
Based on 268 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to choose from templates for multiple types of inspections such as safety or quality
Workflows
Based on 277 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Provides users with workflows to assign tasks for audit and inspections
Corrective Actions
Based on 256 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to identify corrective actions to address incidents and accidents
Compliance (2)
Permits
Based on 209 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to track permits required for environmental and safety compliance
Certifications
Based on 214 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Allows users to manage certifications to comply with regulations and standards
Services (4)
Implementation
Based on 260 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Assists customes through all the phases of the implementation process.
Training & Learning
Based on 265 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Provides software users with training courses and learning content.
Customer Support
Based on 268 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. Delivers customer and technical support, directly or trough partners.
Professional Services
Based on 244 MasterControl Quality Management System reviews and verified by the G2 Product R&D team. The vendor provides consulting services such as business process reengineering.
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.
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.
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.
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.
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.
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.
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.
Documentation - Audit Management (2)
Templates & Forms
Provide out of the box audit templates and forms for various processes and industries.
Checklists
Provides checklists
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.
Monitoring - IT Risk Management (1)
AI Monitoring
Utillizes AI to monitor and report on incidents in real-time.
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.
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.
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
Agentic AI - Operational Risk Management (1)
Proactive Assistance
Anticipates needs and offers suggestions without prompting
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





