Nonconformance Management


Software for Nonconformance Management Helps Assure Compliance with FDA and ISO Quality Requirements

A product's safety and quality depend to a great extent on its conformance to specifications that have been tested and proven safe. For this reason, a nonconformance management system that is adequate is crucial for the proper handling of non-conforming products. This is discussed in FDA regulations covering drugs, medical devices, and biologics; it is also discussed in ISO international standards that apply to manufacturers of a wide range of consumer products.

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White Paper: Effective Nonconformance Management Key to FDA and ISO Compliance
White Paper: 5 Ways MasterControl Ensures System Compliance with 21 CFR Part 11
Interactive and Live Demonstration: MasterControl Quality Management System (QMS) Overview
Product Data Sheet: MasterControl Nonconformance™
Product Data Sheet: MasterControl CAPA™
Product Data Sheet: MasterControl Document Connections™



How Software for Nonconformance Management can be Key to FDA and ISO Compliance

The above white paper, prepared by MasterControl, discusses the significance of nonconformance disposition in the FDA and ISO environments and how software for nonconformance management can help companies turn nonconformance incidents into opportunities for quality improvement. It covers the following:

  • FDA Warning Letter involving nonconformance;
  • FDA Regulations and ISO Standards that require material nonconformance disposition;
  • Common ways of handling material nonconformance;
  • Relationship between nonconformance and corrective action/preventive action (CAPA);
  • Common challenges in nonconformance disposition; and the
  • Software for nonconformance management from MasterControl
  • .

How can the Software from MasterControl for Nonconformance Management Benefit You?

The software from MasterControl for nonconformance management is configurable, easy-to-use, and designed to automate, manage, and streamline paper-based processes for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products.

For More Information on Nonconformance Management

For more information about nonconformance management or the nonconformance software from MasterControl, please feel free to contact a MasterControl representative.