Features of MasterControl

MasterControl offers solutions for Quality, Manufacturing, Clinical, Regulatory, Supplier, Product Development and Postmarket management.  

What is MasterControl?

MasterControl brings quality and operational excellence together, designed to help you develop, manufacture and commercialize products that help people live longer, healthier and more enjoyable lives.


Documents and Change

Automate and manage all your critical compliance, product design and quality event documents from every point along the product lifecycle on single, user-friendly platform. Depend on unparalleled collaboration, change control, obsolescence and archiving functionalities and secure, role-based system access.

Training and Exams

Automate all training activities across the enterprise, from the distribution of tasks, materials and exams to the follow-up, tracking, escalations and verifications needed to effectively manage your quality processes like CAPA, audits and customer complaints. Whenever there's a change to an SOP or any other document linked to a course, all affected employees automatically receive notifications and new training tasks.

Incidents and Corrective Actions

Integrate your corrective actions with quality subsystems — including customer complaints, audits and change control — and track incidents that could potentially escalate into corrective actions. Automate the routing, notification, delivery, escalation and approval of corrective actions and securely store all correlated documentation.

Audits and Preventive Actions

Streamline and automate your audit planning, scheduling and execution activities from beginning to end. Effectively manage your audit findings, responses and related preventive actions and optimize the audit reporting process to create final audit reports faster.

Risk and Mitigation

Unite all of your risk-related activities and documentation in one centralized repository. Capture a complete and accurate picture of your risk landscape across product lines, business processes and business units. Leverage full search and scheduled reporting capabilities to gather insights into your risk assessment and mitigation activities.


Electronic Batch Records

Digitize batch records to improve data integrity, automate calculations and sampling processes, enforce required actions, and integrate with quality management, enterprise resource planning, and manufacturing execution systems.

Electronic Device History Records

Gain control of all manufacturing design specification data and documentation by automating your DHRs for each batch, lot and unit produced.

Equipment Calibration and Maintenance

Increase performance, minimize downtime, and maintain compliance by ensuring instruments, apparatus, gauges, and recording devices are always functioning accurately.

Recipe and Variant Management

Manage recipe changes, variants and substitutions – from materials and ingredients to equipment and processes – in a single master template, significantly reducing product documentation and improving data visibility, tracking and analysis.


Regulatory Information Management

Accelerate the collection, harmonization and management of regulatory documentation and data from product development throughout the global submissions and product registrations life cycle, all in a centralized system.

Registrations Management

Manage the organization and submission of dossiers, technical documents, global checklists templates, and tracking of product requirements for worldwide geographical locations while always keeping product registration data up- to- date.

Submissions Management

Automate and accelerate submission documents, data, regulatory communications and publishing, and gain real-time visibility throughout the submission process, whether it is conducted in-house or via a partner.