Qx

Quality

Design Control

Regulated companies must create and maintain plans that describe or reference their product design and development activities. This means a design control system is essential for these companies.

Medical device and other health care product manufacturers are required to manage many documents to meet design control guidelines. Speed to market is critical. Automating your design history file (DHF) and document management processes gives you an advantage. MasterControl's design control software interconnects data, processes and people. Overall, it enables companies to achieve compliance in less time, with less effort and at a lower cost.

MasterControl Medical Device (DHF) JumpStart™
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Revolutionize the way you manage design controls.

01

Ensuring Product Quality and Compliance

02

An Audit-Ready Design History File

03

Efficient Document Control Systems Accelerate Compliance

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A Design History File That Exceeds Expectations

Losing a requested design history file (DHF) or specific materials in the file can result in costly setbacks. With MasterControl, all documents and artifacts, such as the design and development plan and design input and outputs, are in a central location. This makes it easier to keep the contents up to date and provide a complete DHF during audits.

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Seamless Communication

Paper-based change control management creates roadblocks. Lack of business unit interaction, slow document reviews and missing information causes delays. MasterControl’s design control software unifies companies, improves communication, boosts efficiency, and keeps product releases on schedule.

Avoid Design Control Warning Letters

Maintain a competitive edge with effective design control procedures.

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