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FDA Approved

Maintain and Sustain Your Company’s FDA Approved Standing

Life science companies that thrive in a strict regulatory environment understand that FDA approved status is an ongoing process, not an event. Regulated companies have only cleared the first hurdle by achieving FDA approval—the ultimate goal is sustaining FDA approved status throughout the lifespan of the enterprise. Leading the charge in the document management industry, MasterControl Inc. provides document control solutions to more than 400 regulated companies worldwide. Pharmaceutical, biotechnology, and medical device organizations use MasterControl to attain and sustain FDA approved standing.  MasterControl provides functional solutions that help regulated companies comply with best practice standards and regulations such as FDA 21 CFR Part 11 and Annex 11

About MasterControl Inc.
Salt Lake City, Utah-based MasterControl Inc. is dedicated to helping regulated companies achieve and maintain FDA approved compliance. Taking GxP management to a new level since 1993, MasterControl’s compliance software solutions are specifically geared to help life science companies comply with regulations like FDA 21 CFR Part 11. The MasterControl suite is also designed for adherence to Annex 11, which delineates computerized system usage guidelines for the European GMP sector. Learn more about the history and future of MasterControl.

FDA Approved Status Downloads:

White Paper Download:
5 Ways MasterControl Ensures System Compliance with 21 CFR Part 11

Product Data Sheet:
21 CFR Part 11 Industry Overview - Are You Ready for an FDA inspection?
Q&A Download:
FDA Medical Device Investigator Offers Insightson Inspection
Tech Paper Download:
MasterControl Nonconformance™



 


Regulation Compliance Solutions from MasterControl

MasterControl solutions thoroughly control quality and documents in a centralized, easy-to-use system. The MasterControl management suite features the following applications:

Maintaining FDA Approved Status
The MasterControl suite allows life science companies to maintain FDA approved status by offering easy to implement solutions that exist in a state of continuous validation. MasterControl’s quality management software is specifically designed to meet and exceed the regulation requirements in industries such as pharmaceutical, medical device, biotechnology, blood/tissue, laboratories and contract organizations.

Resource Center
To read case studies detailing MasterControl’s effect on specific regulated companies’ FDA approved status, please visit the Resource Center. The MasterControl Resource Center has other helpful complimentary information, such:

Contact MasterControl
Questions? To learn more about how MasterControl can help your regulated organization achieve a continual FDA approved status, visit the MasterControl website or call 1-800-825-9117.

Related Items:

Online Demos & Recorede Presentations
GxP Lifeline

    Call us for a free consultation:
   800-825-9117


Why is MasterControl the Right Software Solution for Your Industry?

Compliant.
Sustained Regulatory
Compliance

Connected.
Integrated Quality
Management

Complete.
Enterprise-wide
Product Application

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