Nonconformance Software

MasterControl Nonconformance 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. The nonconformance software from MasterControl and MasterControl CAPA can help ensure that your quality initiatives are always Compliant, Connected, and Complete:

Compliant.

Sustained Compliance: The nonconformance software 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.

• Increased Efficiency Through Automation: MasterControl automates all tasks pertaining to handling of a nonconformance, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant.
  

• Centralized Repository: All documents related to nonconformance will be stored in a secure, centralized repository, making it easy to search and retrieve them during audits.

• Best-Practice Form: A pre-configured, multi-page form simplifies the process for nonconformance software and accelerates evaluation and disposition of nonconforming materials by prompting the appropriate departments to collect and track all relevant data. The form is automatically routed to responsible personnel and escalates accordingly if the case is not processed promptly.

• Best-Practice Process: This solution incorporates a five-step process that will help the quality unit make timely and appropriate decisions. The process will guide the team from initiation through investigation, recommendation, disposition, and management approval.

• Analytics Reporting Tool: The Nonconformance solution includes a standard set of pre-configured reports that can be customized by end users. Nonconformances can be trended, and incidents analyzed by material, shift, machine, supplier, etc. These "data-mining" capabilities can give important insight into systemic quality issues and serve as another starting point for CAPA.

• Revision Control: MasterControl provides automatic revision control to ensure that only the current version of a document is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The software tracks all changes made to the InfoCard.

Connected.

Integrated Quality Management: MasterControl connects the nonconformance disposition process with other quality processes for a holistic approach to quality management.

• Easy Access: MasterControl is Web-based so it can connect employees, suppliers, and others involved in the nonconformance process regardless of location.

• Flexible Process: The nonconformance software from MasterControl can be used as a stand-alone process for the purpose of small-scale, localized disposition of nonconforming materials. But the system is flexible and it allows integration with the CAPA process if the situation warrants a separate CAPA handling while the initial nonconformance is independently processed and closed.

• Form-to-Form Launching: A CAPA form can be launched directly from a nonconformance form, connecting one process to the next. Not only does MasterControl streamline this process, but it also maintains the links so one can review a completed process and easily see what triggered the CAPA. Relevant information from the nonconformance form will be automatically entered into the CAPA form, reducing data entry and increasing accuracy.

Complete.

Enterprise-wide Product Application: MasterControl can handle every department's forms-based processes, making it an ideal enterprise-wide solution.

• Integrates with Other Applications: MasterControl can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.

• Easy to Search: A standardized Google-like search window comes with the nonconformance software and with all integrated applications from MasterControl, which means all authorized users throughout the organization can search and retrieve change control-related tasks and documents.

• Easy to Find: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.

• Automation of Forms-Based Processes: Any forms-based process unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be automated. A department can keep the look and function of existing forms or create entirely new ones.

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