—Increase Speed-to-Market with MasterControl —

Compliance & Quality Management Solution

Enterprise Quality Management System that enables companies to eliminate paper-based processes while adhering to strict FDA regulations, ISO quality standards, and other international regulations.

More than 1,000 companies worldwide, including 3 of the top 5 life science providers, rely on MasterControl because of its unbeatable ROI: on average, 160% payback in less than 12 months after purchase.

Highlights of the MasterControl System

MasterControl is an off-the-shelf, configurable, and easy-to-use solution that combines industry best practices with the flexibility to meet every customer's unique needs. World's first Compliance Quality Management Software System to become 21 CFR Compliant.

Document Control

Automates all document routing, delivery, escalation and approval processes and makes the search for and retrieval of documents easy during audits or inspections.

Corrective & Preventive Action System

The MasterControl CAPA system interconnects different quality subsystems and tracks incidents that can escalate into a corrective action.

Change Control

MasterControl Change Control offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high.

Quality Audit Management

Comply with regulations and quality standards, while increasing operational efficiency, improving product quality, and accelerating time to market — all at the lowest possible cost.

Forms-Based Process Automation

MasterControl automates routing, notification, escalation, and approval of any forms-based process for faster turnaround.

Complaint Management

A simple process is incorporated in a pre-configured form that starts with the processing of a complaint, automatically moving to internal investigation, and culminating with a resolution.

"I feel safe knowing our quality documents are in a secure, validated system that I can access almost anywhere, and that they sit in a system the FDA themselves use! As a pharma/device company, the FDA's seal of approval on an electronic QMS system means a lot to us! I'm glad our company chose the gold standard eQMS to implement."

- Adrienne O'Reilly, Quality Assurance Manager

"The software is very user-friendly, and the Customer Support from Sales through Technical Account Management is exemplary... I would recommend MasterControl for any size company, both regulated & non-regulated. And if you don't have the internal resources to install the software, MasterControl can assist by hosting the software."

- Patrick Farley, System Administrator Lead

Stay On Top of Ever-Changing Regulations & Quality Standards


MasterControl's integrated solution increases efficiency, resulting in a faster throughput process and a shorter cycle time.


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