FDA QSR Regulations

FDA QSR Quality System Regulation (21 CFR Part 820) Software Solutions for Compliance with Requirements Applicable to Medical Device Manufacturers

The medical device industry is one of the world's most strictly regulated industries. Just to stay in business, medical device companies must comply with a plethora of stringent regulations, including the FDA QSR.

Is your company's documentation FDA QSR compliant?

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21 CFR Part 820 – ISO 13485 Harmonization

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Free Resources on FDR QSR Compliance

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White Paper: Engineering and Quality Teams in Medical Device Firms: Can We All Get Along? White Paper: cGMP and ISO 13485 Integrated Quality Management System White Paper: Automating Document Control Processes to Comply With FDA and ISO Requirements
Data Sheet: MasterControl eTMF Manager for Medical Device

MasterControl's FDA QSR Compliance Software Solutions

FDA QSR compliance is a perpetual state, not a singular event. Medical device companies must not only achieve FDA QSR compliance, but continually maintain it with the aid of robust software solutions. The MasterControl™ integrated quality management suite is a powerful, user-friendly solution that allows medical device manufacturers maintain compliance with FDA QSR and other regulatory standards by automating and effectively and efficiently managing crucial quality processes.

Validating a software solution according to FDA QSR requirements - and keeping the system in a perpetual state of validation - is one of the most difficult aspects of maintaining regulatory compliance. MasterControl is continually developing new means of streamlining processes, reducing validation efforts, and simplifying validated software upgrades.

FDA QSR Documentation Must be Controlled

To assure FDA QSR compliance, all vital documentation must be tightly controlled and continually reviewed and compared against definitive processes. Maintaining such a level of control requires cutting edge software solutions. MasterControl, a global leader in FDA QSR-compliant software solutions, specializes in document control, audit and process management solutions for medical device companies.

Disconnected quality processes result in delays, scrap, rework, and inadequate results. For instance, a change control process that is not connected to customer complaint, CAPA, training, and other quality processes will inevitably result in delays to change implementation. MasterControl offers highly efficient CAPA processes that are directly connected to the entire quality system, subsequently eliminating unreliable root cause investigations that may otherwise result from the inadequate transfer information.