MasterControl

Connects quality, manufacturing, and asset management on a compliant platform to support efficient, secure life sciences operations.

Connects quality processes and automates routine tasks to support compliance and help life sciences organizations bring quality products to market faster.

Digitizes and connects manufacturing operations to reduce errors, strengthen compliance, improve visibility, and accelerate product release.

Helps regulated organizations manage assets and calibration, maintain compliance, improve equipment reliability, and support audit readiness.

Streamlines eTMF management, improves clinical process visibility, and aligns clinical operations and quality while supporting risk management and GCP compliance.

Integrates quality into product development, improves lifecycle visibility, and helps teams introduce products faster while managing risk and compliance.

Streamlines global submissions and registrations, improves regulatory visibility, and helps bring products to more markets sooner while supporting long-term compliance.

Improves supply chain visibility, supplier compliance, and quality by connecting supplier management with quality processes and documentation.

Connects postmarket feedback and quality processes to help manage product safety, mitigate risk, and support compliance.

Helps life sciences teams make informed decisions with operational visibility, predictive insights, and opportunities to improve efficiency and compliance.

Helps save time, support compliance, and improve quality and manufacturing efficiency with specialized AI tools that keep users in control.

Reduces validation time and documentation effort while helping life sciences organizations maintain compliance and focus testing on relevant changes.

MasterControl ADAPT platform

MasterControl’s Advanced Data and Process Technology (ADAPT) platform provides compliant architecture for life sciences, connecting quality, manufacturing, and asset management. It brings together business intelligence, validation, an agentic AI platform, data platform, integrations, identity management, operations, security, and cloud capabilities. The platform supports regulatory compliance, connects quality assurance, manufacturing, and asset management in a closed-loop system, and governs data input and storage within the MasterControl environment.

• Connect Core Operational Processes
  Unifies quality assurance, manufacturing, and asset management on one platform, supporting connected processes and shared data across these areas.
• Support Regulatory Compliance
  Provides a platform designed around global regulatory requirements and standards for regulated life sciences environments.
• Apply Life Sciences AI
  Offers specialized AI architecture and tools for life sciences workflows, with user control and human review of generated outputs.
• Protect Customer Data
  Keeps customer data within MasterControl’s secure environment for processing and applies controls for privacy, access, and data governance.
• Connect Critical Business Systems
  Connects MasterControl with other critical business systems to support integrated operations and data flows.
• Identify Trends And Track KPIs
  Provides visibility into trends, status, and KPIs to help organizations act on operational information and make decisions.
• Manage Data Across Solutions
  Uses advanced data management across connected solutions as part of a modern platform architecture.
• Support Risk-Based Validation
  Provides a risk-based validation methodology intended to support validation needs in regulated life sciences operations.

MasterControl Quality Excellence

MasterControl Quality Excellence is an AI-enhanced quality management system for life sciences organizations. It connects quality event management, document management, and training in a digital closed-loop system. Teams can configure event forms and workflows without code, automate routing, collaborate on documents, manage employee training and exams, and use AI tools to summarize events, identify deviation trends, and assist with document and exam tasks. Packages range from basic document management to a complete digital QMS.

• Configure And Route Quality Events
  Adapt quality event forms and workflows without code, automate routing based on conditions, and connect event processes with related quality activities.
• Control Documents And Approvals
  Manage document creation, approvals, versions, signatures, archiving, and collaboration in connected processes, with searchable and traceable documents.
• Manage Training And Competencies
  Coordinate training tasks and role-based exams, maintain employee training and competency records, and trigger relevant training from connected quality and production processes.
• Connect Quality Processes
  Link quality event management with documents, change control, training, and exams to coordinate related processes.
• Summarize Events And Identify Trends
  Use AI-generated event summaries and deviation trend identification to help teams review quality information and make decisions more quickly.
• Apply Secure, Expert-Guided AI
  Apply AI tailored to life sciences on a platform designed for data security and integrity, with human-in-the-loop controls.
• Translate Documents And Summarize Changes
  Automate document translation and use AI-generated change summaries to reduce translation effort and streamline document review.
• Generate Exams With AI
  Use AI-assisted exam generation to reduce the time spent creating training exams.
• Scale Your Quality Management System
  Choose a package ranging from basic document management to a complete digital QMS, with options tailored to organizational needs.

Manufacturing Excellence

MasterControl Manufacturing Excellence is a digital manufacturing platform for regulated industries that digitizes production records, execution processes, logbooks, and asset management. It connects manufacturing operations with systems such as ERP, LIMS, and QMS, as well as shop-floor equipment, to improve visibility, data integrity, and operational control. No-code workflows, electronic records, automated data capture, and real-time process controls help manufacturers reduce errors, streamline production, and accelerate product review and release.

• Digitize And Orchestrate Production
  Configure manufacturing workflows and production tools without code, automate processes, and coordinate resources to support flexible, visible operations.
• Capture Production Data Accurately
  Replace paper-based production records with digital records and built-in controls that support accurate data capture and help prevent production errors.
• Accelerate Product Review And Release
  Use automated quality event resolution and real-time review-by-exception to move production records through review and support faster product release.
• Connect Systems And Shop-Floor Equipment
  Integrate enterprise and quality systems with production processes and shop-floor equipment to improve data flow, visibility, and access to production and quality information.
• Digitize Logbooks And Maintain Audit Trails
  Replace paper logbooks with digital records that provide visibility into equipment and facility activities while maintaining audit trails and supporting GMP compliance.
• Manage Asset Maintenance And Calibration
  Track asset status and lifecycle events, schedule maintenance based on time or usage, and manage calibration with secure, traceable records.
• Generate Compliant Manufacturing Documents
  Automate the creation of customizable manufacturing documents to reduce manual documentation work and support consistent production records.
• Identify Trends And Production Issues
  Use operational data, predictive analytics, and KPI tracking to identify production bottlenecks and opportunities for process improvement.
• Automate Validation Of Software Updates
  Run additional validation tests through an automated process to validate updates against workflows and the operating environment.

Asset Excellence

MasterControl Asset Excellence is a cloud-based suite for asset owners and service providers in regulated industries. It combines regulated asset management, commercial calibration management, and computerized maintenance management functionality. The suite tracks assets throughout their lifecycle, supports maintenance and calibration activities managed in-house or by external vendors, and provides digital records, audit trails, compliance documentation, and reporting. It also supports calibration service providers with uncertainty calculations, scheduling, reference standard management, task allocation, real-time tracking, and a collaborative client portal.

• Prepare Records For Regulatory Inspections
  Maintain digital records, audit trails, and compliance documentation, and generate reports for regulatory inspections and applicable standards.
• Calculate Calibration Uncertainty
  Use the built-in uncertainty engine to support precise calibrations and traceability to standards such as ISO 17025.
• Track Assets Across Their Lifecycles
  Keep asset lifecycle activities visible and track maintenance, warranty expirations, and change requests, whether work is managed internally or by external vendors.
• Centralize Maintenance And Asset Data
  Bring maintenance, calibration, and asset data together and manage schedules through workflows that support regulated operations.
• Schedule Maintenance And Prevent Failures
  Set maintenance activities to trigger at defined times or usage levels and use performance data and alerts to help predict failures and reduce downtime.
• Manage Calibration Records And Reminders
  Keep calibration activities on track with automated reminders, service history, and securely stored documents for in-house or vendor-managed work.
• Automate Calibration Workflows
  Automate compliance workflows and scheduling to help providers coordinate calibration work and reduce administrative effort.
• Maintain Secure Digital Records
  Keep secure, accessible digital calibration certificate records to support audit preparation and client reporting.
• View Asset Status And Health
  See asset status and health, and filter lifecycle events to support operational control and audit readiness.
• Coordinate Calibration Service Work
  Organize schedules, reference standards, and task assignments, while maintaining digital certificate records for audits and client reporting.
• Track Service Work In Real Time
  Gain visibility into service work to support reliable service delivery.
• Collaborate Through A Client Portal
  Support provider-client interaction through a collaborative portal.

MasterControl Clinical Excellence

MasterControl Clinical Excellence connects clinical operations and clinical quality on a single platform. It streamlines electronic trial master file (eTMF) management by digitizing, automating, and connecting documents, images, and other clinical trial content throughout the trial lifecycle. The solution supports site protocol, SOP, and reporting management across sites, provides real-time visibility into critical clinical processes, and embeds quality processes in clinical trials to support risk management and GCP compliance.

• Connect Clinical Operations And Quality
  Brings clinical operations and clinical quality together on one platform to support alignment between teams.
• Digitize And Streamline eTMF Management
  Helps teams manage eTMF documents and artifacts through digitized, automated, and connected processes.
• Embed Quality And Support GCP Compliance
  Enables teams to apply quality processes within clinical trials to help manage risk and support GCP compliance.
• Manage Clinical Trial Content
  Helps teams manage documents, images, and other essential digital content as part of the eTMF throughout the trial lifecycle.
• Gain Real-Time Clinical Process Visibility
  Gives operational teams real-time visibility into critical clinical processes on a centralized platform.
• Coordinate Protocols, SOPs, And Reporting
  Helps teams coordinate site protocols, SOPs, and reporting across sites.

MasterControl Development Excellence

MasterControl Development Excellence streamlines the collection and compilation of new product development documentation, integrates quality requirements early in the design process, and manages design control throughout the product development lifecycle. It supports collaboration across multiple sites while maintaining visibility and quality. The solution simplifies design control and bill-of-materials processes and aligns quality and compliance with product development to support faster changes, approvals, notifications, and transfers. Integrated quality processes support risk management and help ensure market feedback and customer complaints inform product evolution.

• Embed Quality From Day One
  Integrate quality into design from the beginning and carry relevant documentation and data with the product throughout its lifecycle.
• Manage Design Control
  Simplify design control and align quality and compliance processes with product development throughout the lifecycle.
• Accelerate Product Introductions
  Support faster product introductions through quicker changes, approvals, notifications, and transfers.
• Streamline Development Documentation
  Organize the collection and compilation of new product development documentation to support development activities.
• Integrate Quality Processes
  Connect core quality processes with product development throughout the lifecycle to support quality improvement and risk management.
• Simplify Bill Of Materials
  Manage bill-of-materials processes as part of product development and product introduction.
• Collaborate Across Multiple Sites
  Support collaboration across sites while maintaining visibility and quality throughout product development.
• Use Feedback To Inform Product Evolution
  Connect market feedback and customer complaints to product evolution.

Regulatory Excellence

MasterControl Regulatory Excellence is a regulatory information management solution that streamlines global registrations and agency submissions. It digitizes, automates, and connects regulatory management on a centralized platform, helping teams manage dossiers, improve collaboration and accuracy, simplify template management, and gain visibility across geographies, operational teams, and in-market partners. Connecting regulatory and quality management supports initial clearance and registrations while helping ensure long-term compliance.

• Digitize Regulatory Dossiers
  Manage digital dossiers for agency submissions and global registrations, supporting accurate and collaborative regulatory work.
• Streamline Agency Submissions
  Coordinate regulatory submissions on a centralized platform to streamline processes and help products reach markets sooner.
• Accelerate Global Registrations
  Manage global product registrations more efficiently to support entry into more markets sooner.
• Improve Regulatory Process Visibility
  See the status of submissions and registrations across markets, teams, and partners to help identify bottlenecks and information gaps.
• Connect Regulatory And Quality
  Link regulatory and quality management processes to support initial clearance, registrations, and ongoing compliance.
• Simplify Regulatory Templates
  Simplify template management to support more accurate, collaborative regulatory work.

MasterControl Supplier Excellence

MasterControl Supplier Excellence provides digital supply management for life sciences manufacturing. It helps organizations plan, control, and execute supply chain activities from materials procurement through distribution, manage supplier documentation, data, and workflows in a central repository, and connect quality with supply chain management. The solution supports visibility, traceability, and accountability across approved suppliers, partners, and distributors, helping organizations manage risk, support GMP compliance, and maintain quality across the supply chain.

• Centralize Supplier Information
  Keep supplier documentation, data, and workflow processes in one central repository.
• Manage Supply Chain Activities
  Manage supply chain activities from materials procurement through distribution.
• Connect Quality And Supply Chain Processes
  Bring quality and supply chain management together and extend quality processes across the supplier network.
• Improve Supplier Network Visibility
  Gain visibility across approved suppliers, partners, and distributors to support traceability, accountability, and audit readiness.
• Manage Supplier Risk
  Use connected quality and supply chain processes to manage risk across suppliers, partners, and distributors.
• Support GMP Compliance
  Streamline quality processes across the supplier network to help ensure GMP compliance.
• Manage Supply Chain Changes
  Keep supplier management current as manufacturing processes change and new suppliers and product designs are introduced.
• Improve Finished Product Quality
  Connect quality and supply chain processes to improve finished product quality and help elevate customer satisfaction.

Postmarket Excellence

MasterControl Postmarket Excellence is an integrated, closed-loop system for managing postmarket surveillance and customer feedback throughout a regulated product’s lifecycle. It helps organizations track and analyze issues, manage risk, monitor product safety, and connect postmarket activities with core quality processes to support compliance.

• Manage Customer Feedback
  Bring customer feedback and complaints into one system for tracking and analysis throughout the regulated product lifecycle.
• Monitor Product Safety
  Manage postmarket surveillance activities while monitoring product safety after products are cleared for consumer use.
• Track Issues And Mitigate Risk
  Connect postmarket activities and customer feedback to improve issue tracking and analysis and support risk management.
• Connect Surveillance With Quality
  Unite postmarket surveillance activities with core quality processes to support risk management and compliance.
• Track Postmarket Activities
  Monitor postmarket activity status, feedback by product group, elapsed and average times, and responses awaiting regulatory acknowledgement.

MasterControl Insights

MasterControl Insights provides advanced analytics and business intelligence for life sciences organizations. It helps teams use operational data from MasterControl solutions to identify trends, analyze production status, track KPIs, and spot potential issues and process improvements. Capabilities include predictive analytics, preconfigured dashboards, interactive reporting, data drill-down and filtering, and scheduled notifications. Insights provides visibility across MasterControl solutions, including Quality Excellence and Manufacturing Excellence.

• Anticipate Issues And Improve Processes
  Identify trends and potential issues and find opportunities to improve processes before problems affect operations.
• See Data Across MasterControl Solutions
  Bring operational data from MasterControl solutions into view to help teams understand status and trends.
• Spot Bottlenecks And Optimize Processes
  Identify production bottlenecks and opportunities to optimize processes and save costs.
• View Operational Status At A Glance
  Use preconfigured dashboards to review status and operational data and act on the information.
• Create Interactive Reports And Dashboards
  Build interactive reports, visualizations, and dashboards with tools designed for business users.
• Analyze Production Status
  Review production status through Insights and use the information to take action quickly.
• Track Key Performance Indicators
  Monitor KPIs to maintain visibility into operational performance.
• Explore Data In Greater Detail
  Filter and drill into data to examine details behind operational metrics and dashboard information.
• Keep Stakeholders Informed Of Trends
  Schedule notifications to share visibility into trends and tracking with key stakeholders.

MasterControl AI for Life Sciences

MasterControl AI for Life Sciences is a collection of native AI tools and capabilities built on a secure, specialized platform for life sciences quality and manufacturing workflows. The tools generate and summarize content, analyze quality and manufacturing data, support regulatory inquiries, and automate tasks such as document translation and exam creation. AI processing is governed within MasterControl’s environment, and users review generated outputs and remain responsible for how they are used. The platform is certified to ISO 42001 standards for AI management systems.

Category: AI Assistant Software

• Keep Users In Control Of AI Outputs
  Support human review and approval of generated information. Users decide whether and how outputs are used, and AI does not independently make decisions within validated workflows.
• Process AI Data Within A Governed Environment
  Keep AI processing within MasterControl’s secure and governed environment using MasterControl-administered models, services, and agents.
• Apply AI Built For Life Sciences
  Use AI tools designed for life sciences quality and manufacturing workflows, with an approach tailored to regulated industry requirements.
• Identify SOP Compliance Gaps
  Analyze an uploaded SOP against regulations to identify gaps and provide suggestions, draft text, and citations to support updates.
• Support Responsible AI Governance
  Rely on an AI management system certified to ISO 42001 standards.
• Create And Revise Digital Batch Templates
  Convert paper batch records, generate templates from instructions, or revise existing records through a chat interface.
• Identify Deviation Trends
  Analyze deviation data across quality and manufacturing to make trends easier to understand and support timely action.
• Predict And Detect Batch Deviations
  Use AI-assisted batch monitoring to predict potential deviations and identify them in real time for prompt review and response.
• Summarize Documents And Revisions
  Summarize documents and highlight changes between versions to support document review and make information easier to locate.
• Navigate Regulatory Requirements
  Explore regulatory information using natural-language queries, with citations and references for transparency. Current coverage includes U.S. Code of Federal Regulations and EU MDR.
• Activate AI When Users Choose
  Keep AI use under user control: capabilities are initiated by explicit user actions, operate within existing permissions, and do not run automatically in the background.
• Summarize Complex Quality Events
  Generate summaries of complex quality events to help users review information and accelerate decision-making.
• Recommend Corrective Actions
  Provides suggested corrective actions to help users respond to batch monitoring findings.
• Flag Potential Training Delays
  Identify potential overdue training risks through dashboard alerts and help users stay ahead of deadlines.
• Generate Training Exam Questions
  Create multiple-choice questions and answers from content to assess employee comprehension.
• Translate Procedural Documents
  Translate critical procedural documents into multiple languages so global workforces can access training in their native languages.
• Find Answers In MasterControl Data
  Ask questions about document content and other stored data to make information easier to access.
• Convert Paper Logbooks Into Templates
  Generate logbook templates from uploaded paper versions to streamline the creation of digital logbooks.

Validation Excellence

MasterControl Validation Excellence provides patented, risk-based validation tools and methodology for life sciences organizations using MasterControl software. It helps teams focus validation on changes that affect critical business processes, manage validation within release and change control, and generate documentation for regulatory inspections, supplier audits, and customer quality agreements. The tools are embedded in the MasterControl platform at no additional cost. Specialized validation services include integration utility validation, custom form validation, data verification qualification, and consultation tailored to regulatory requirements.

• Focus Validation On Critical Processes
  Tailor validation to business needs and software use, concentrating effort on areas relevant to critical business processes while supporting compliance.
• Identify Changes Requiring More Scrutiny
  Review release changes with calculated risk scores to identify areas that may need additional validation attention.
• Validate Relevant Changes Faster
  Focus upgrade reviews on changes affecting critical business processes. MasterControl reports an average upgrade validation time of under 45 minutes.
• Support Compliant Release Changes
  Integrate validation into release and change control processes to manage software changes while maintaining GxP compliance.
• Prepare Documentation For Inspections
  Generate validation documentation for regulatory inspections, supplier audits, and customer quality agreements.
• Reduce Testing And Preparation Effort
  The risk-based approach can reduce additional formal testing and preparation work. MasterControl reports that over 90% of VxT customers do no additional formal testing and save an average of over 330 hours on project preparation.
• Tailor Validation To Requirements
  Receive personalized consultation from validation experts tailored to specific regulatory requirements.
• Validate Integration Utilities
  Receive specialized validation services for integration utilities from MasterControl’s validation experts.
• Validate Custom Forms
  Get specialized validation support for custom forms from MasterControl’s validation experts.
• Qualify Data Verification
  Use specialized services to qualify data verification, provided by MasterControl’s validation experts.
• Access Embedded Tools At No Extra Cost
  Use validation tools embedded in the MasterControl platform without an additional charge.