The MasterControl nonconformance software system is designed to help companies in ISO and FDA regulated environments automate paper-based nonconformance processes and integrate them with corrective and preventive action (CAPA) processes within the company-wide quality system.
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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 system that is adequate is critical for the proper handling of nonconforming products. This is discussed in FDA regulations covering drugs, medical devices, and biologics; it is also discussed in ISO international standards, which apply to manufacturers of a wide range of consumer goods.
Most general manufacturers and their suppliers comply with ISO international standards to help maintain the highest quality standards and compete better in the global market. ISO 9001:2000 and ISO 14001:2004, both widely used in this industry, require the establishment and maintenance of procedures for manufacturing nonconformance to ensure product safety. Adherence to ISO standards is voluntary, although certain countries require ISO certification and many customers prefer vendors and suppliers that are ISO-certified. MasterControl provides nonconformance software systems to ensure compliance of product materials and finished goods according to ISO regulations.
Oil and gas companies find it beneficial to conform to ISO quality standards, such as ISO 9000 and ISO 14000, to help ensure safe, reliable, and high-quality products and services. Adherence to ISO standards is largely voluntary, but the U.S. Environmental Protection Agency (EPA) encourages the use of ISO 14000 to help organizations improve their environmental performance and to prevent pollution. Both ISO 9001:2000 and ISO 14001:2004 require the establishment and maintenance of nonconformance systems to attain the highest quality standards.
Let’s see how the nonconformance software systems from MasterControl and MasterControl CAPA can help ensure that your quality initiatives are always Compliant, Connected, and Complete:
Sustained Compliance: The nonconformance software systems from MasterControl is designed not only to help meet ISO standards and attain FDA compliance, but to sustain compliance over the long term by optimizing the nonconformance disposition process, speeding up turnaround from initiation to approval, and keeping the overall quality system always ready for inspections and audits.
Integrated Quality Management: MasterControl connects the nonconformance disposition process with other quality processes for a holistic approach to quality management.
Enterprise-wide Product Application: MasterControl can handle every department's forms-based processes, making it an ideal enterprise-wide solution.
For more information about nonconformance software and nonconformance systems please feel free to contact a MasterControl representative.