FDA Warning


An FDA warning is designed not only to protect consumers of food, drugs and medical devices, but is also designed to assist producers of these items in working more effectively toward the implementation of quality and regulatory guidelines.

MasterControl, a software company, produces the document control, audit and process control software solutions that allow FDA-regulated companies to avoid the receipt of FDA warnings.

FDA Just Called! Now What?

 

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The Art of Avoiding FDA Warnings

When it comes to avoiding FDA warnings, there are many aspects of compliance that life science companies need to take into account. Is quality being represented within management groups? Are regular quality meetings taking place? Is documentation established and adhered to? Is employee training commensurate with FDA requirements? Are processes such as customer complaints management, audit management, change control and CAPAs in place and effectively managed? Are 21 CFR Part 11 standards being met?

With so many aspects of FDA compliance to consider, companies need a solution that will help them manage compliance with a web-based solution. MasterControl provides the web-based system that allows companies to implement the solutions they need for their regulated business to stay safe from FDA Warnings. To do so, MasterControl provides the following solutions:

  • MasterControl Process™
  • MasterControl Documents™
  • MasterControl Audit™
  • MasterControl Deviations™
  • MasterControl Nonconformance™
  • MasterControl Customer Complaints™
  • MasterControl Change Control™
  • MasterControl CAPA™
  • . . . and more!

Software Validation Helps Avoid FDA Warnings

In addition to a wide variety of web-based solutions for highly regulated companies, MasterControl also provides validation solutions and services for companies who refuse to pay as much for validation as they did for their software.

Learn More About How to Avoid FDA Warnings

For more information in regard to avoiding FDA warnings with the help of MasterControl's web-based software solutions, please feel free to contact a MasterControl representative.