MasterControl Quality Management System Features

Supports all required file types including but not limited to: Google Docs, MS Office, images, videos, etc.

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.

Can structure unstructured data through Optical Character Recognition or other automated filing/tagging processes for scanned documents.

Keep track of incrementally changing versions of the same file.

Multiple users can collaborate on document creation, annotation, and review.

Autogenerate documents based on templates and form submission.

Able to create and manage submittable user forms.

Able to create user portals and sites.

Automatically archive, delete, or revoke access to files that have reached the end of their life cycle.

Can easily find files via a simple and/or advanced search.

Ability to access documents via a web interface without a client being installed on a device.

iOS, Android and Windows phone apps provide functionality that enable users to perform the same functions as they would on a PC.

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.

The workflow engine provides relevant and customizable conditions on which to execute rules.

Any action a user can perform in the system can be specified as an automated action.

System provides the necessary tools and fuctionality to maintain evidence of business activites and comply with governmental requirements or industry standards.

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.

Allows organizations multi-national organizations to use tool effectively across multiple languages and currencies.

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.

Access pre-built and custom reports to monitor user activity and storage.

Integrates with other systems of record such as CRM, ERP, Outlook, Sharepoint.

Enables custom integration to external systems.

Delivers APIs and standard integrations with other software systems.

Complies with security and privacy regulations and standards.

Allows users to access the software using mobile devices.

Facilitates software configuration without the need for technical experise.

Ensures that the product development process stays on track and continues to meet both user and vendor needs

Prepares for, plans, manages, schedules, and conducts internal and external audits

Connects suppliers with product developers with consumers

Reviews, identifies, and assesses sources of risk in research and development

Collects both vendor- and customer-facing data relevant to the product development lifecycle, and generates performance and health reports

Enables real-time collaboration like automated notifications and rich editing and commenting capabilities to minimize miscommunication

Automates, centralizes, and archives documents and forms to create a single source of truth

Automates and manages processes like CAPA (Corrective and Preventive Action) to monitor quality and complaints and promote transparency

Permits use by job roles outside of service department

Allows linking of useful information such as screen shots

Provides direct contact between CSRs and customers outside of milestones

Informs stakeholders of activity on escalated or high-value cases

Evaluates frequency of types of complaints

Includes a dashboard or other means of performance monitoring

Allows users to create, track and maintain accurate, auditable conformance records.

Allows users to assign tasks for corrective and preventive actions (CAPA) to employees in nonconformance

Allows users to submit change requests and control plan revisions at any point in the production process and track all revisions.

Allow users to centralize and archive documents for quality management

Allows users to collaborate in real time with editing and commenting capabilities to minimize miscommunication

Allows users to collects both vendor- and customer-facing data relevant to the product development lifecycle, and generates performance and health reports

Allows users to determine potential risks that may impact employees or the environment

Allows users to estimate the impact of EHS risks on the operations of the company

Allows users to evaluate suppliers using safety and environmental criteria

Allows users to choose from templates for multiple types of inspections such as safety or quality

Provides users with workflows to assign tasks for audit and inspections

Allows users to identify corrective actions to address incidents and accidents

Allows users to track permits required for environmental and safety compliance

Allows users to manage certifications to comply with regulations and standards

Assists customes through all the phases of the implementation process.

Provides software users with training courses and learning content.

Delivers customer and technical support, directly or trough partners.

The vendor provides consulting services such as business process reengineering.

Offers customizable dashboards and analytics to track completeness, compliance, quality, and timeliness of the study.

Offers a pre-built DIA TMF reference model hierarchy, and allows for configurable reference models to meet the specific needs of organizations and sponsors.

Supports inspections and regulatory audits by maintaining inventory and document reports, and having pre-built compliance with all relevant regulatory guidelines.

Designates customizable user roles and limit access to certain functions in the eTMF.

Allows users to upload multiple documents at once and provides dynamic indexing options.

Manages the status of all trial documentation at all stages and flags missing documentation.

Tracks each version of a document and shows changes from each version or reupload.

Allows documents and metadata to be easily searched within the system.

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.

Allows external or remote contributors to upload documents and work collaboratively in a controlled method.

Configures review, e-signature, and approval workflows for all documentation.

Tracks submissions plans for products to report against milestones and progress. Streamlines the entire dossier lifecycle and tracks the status of all submissions.

Supports the creation of technical files and essential principles checklists.

Provides templates and tools to create all planned regulatory content for a product.

Stores all previously submitted documents for use in audits or future submissions.

Enables traceability into the entire pre- and post-market lifecycle to monitor milestones, time to completion, and updates and approvals.

Prepares and submits labels and UDI submissions for products, validated accordingly to regional regulatory requirements.

Maintains up-to-date dashboards for overseeing every task, deadline, project status, and workflow.

Allows multiple users to collaborate on documents and flag errors or updates.

Centralizes and tracks detailed product information, such as registration status and selling status for each location and market.

Tracks key deadlines for submissions, renewals, and audits, and streamlines the document retrieval process for each activity.

Streamlines post-market product data collection and analysis for safety, sentiment, and future product improvements.

Fields internal team and external agency messages or tickets related to regulatory concerns, and inboxes all correspondences.

Connects to regulatory databases and market sources to monitor upcoming changes that may impact product selling status.

Allows users to generate text based on a text prompt.

Condenses long documents or text into a brief summary.

Allows users to generate text based on a text prompt.

Condenses long documents or text into a brief summary.

Allows users to generate text based on a text prompt.

Automates basic tasks and workflows utilizing AI.

Displays all the changes made during audits, including details such as username, timestamp, or type of change in a centralized repository.

Coordinate and track recommended remediation actions.

Facilitates collaboration between teams and stakeholders through shared workspaces.

Integrates with risk management platforms, GRC tools, and other systems.

Facilitates the creation of audit plans, schedules, and reminders.

Provide out of the box audit templates and forms for various processes and industries.

Provides checklists

Dashboard provides real time or near real time updates and notifications in a centralized location.

Provide information on the performance of the audit activities and processes.

Ensures audits are compliant with industry-specific regulations and standards.

Utillizes AI to monitor and report on incidents in real-time.

Support various methodologies and frameworks for operational risk management such as ISO 31000 and COSO.

Ability to classify risks based on risk type, severity, and custom criteria.

Identify various risk factors such as the inadequate use of technology, human factor, or external risks.

Support business continuity plans through integrations with business continuity software, incident response, or controls planning

Reduce risk of legal liability through regulations and standards compliance.

Capability to perform complex tasks without constant human input

Ability to break down and plan multi-step processes

Anticipates needs and offers suggestions without prompting

Capability to perform complex tasks without constant human input

Engages in human-like conversation for task delegation

Makes informed choices based on available data and objectives