Customer complaint management is essential to the success of any regulated business. It is especially critical for regulated companies because complaints may indicate serious safety issues. For example, under the Current Good Manufacturing Practice (CGMP) regulations outlined in 21 CFR Parts 210-211, pharmaceutical companies are required to establish written procedures for complaint handling regarding a drug product and to determine whether a complaint represents a serious adverse experience that needs to be reported to the FDA.
The MasterControl integrated quality management suite is a configurable and easy-to-use software solution that helps ensure regulatory compliance with customer complaints management. Recognizing that validating a software solution (as required by 21 CFR Part 11 ) is a necessary component in CGMP compliance, MasterControl offers full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
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Sustained Customer Complaints Management and Compliance: MasterControl helps manufacturers attain and sustain compliance with ISO quality standards by optimizing the complaint-handling process, speeding up the turnaround from complaint submission to resolution, and keeping the overall quality system always ready for ISO quality audits.
Revision Control: MasterControl ensures that only the current version of a document is available.
Integrated Quality Management: MasterControl connects the paperless customer complaints management process with other quality processes for a holistic approach to quality management.
Enterprise-wide Product Application: MasterControl can handle every department's forms and documents-based processes, making it an ideal enterprise-wide customer complaints management solution.
For more information about complaint handling or customer complaints management, please feel free to contact a MasterControl representative.