Incident Reporting Software - MasterControl Incident Reporting™ Solution


An integral part of quality management is the ability to capture quality events as a starting point for containment, corrective action, and preventive action. Examples of such defined quality events include: Nonconformances, Deviations, Variances and Customer Complaints. Other issues and observations may occur that do not fit any of these categories with the consequence of either being ignored or fed into one of these event handling systems regardless of suitability. In the first case, quality-related information is lost, and in the latter the handling system may become clogged and slowed down.

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How Can MasterControl Incident Reporting Software Help You?

MasterControl Incident Reporting serves as a pre-screen system to capture a wide variety of quality and non-quality events and to escalate issues to the appropriate channels. Here are some examples of how MasterControl is helping companies resolve major incident reporting issues:




 

Challenges MasterControl Solution



Incorrect Observations:

Inappropriate CAPAs or other quality events are logged. This increases the work load on quality personnel and distracts from real problems. It also exposes more cases to scrutiny during an audit.

Streamlined Incident Reporting:

MasterControl serves as a pre-screen of issues, promoting only valid issues to a quality event when necessary. It can also route the issue to non-quality functions such as Human Resources.




Disconnected System:

Personnel often make observations but have no easy way to communicate such observations. Quality event information is missed and corrective action cannot be taken.

Connected System:
MasterControl Incident Reporting provides an automated system to log and evaluate observations from a broad range of personnel and processes. As such, it serves as a valuable source of additional quality information.






Features and Benefits of MasterControl Incident Reporting:

  • Automatic Routing: : Issues are automatically routed to a designated Incident Coordinator who routes the report appropriately. Participants can be added “on the fly” as needed.
  • Robust Reporting Capabilities: Using MasterControl’s fully customizable reporting, the incident report queue can be monitored and the occurrence of incidents analyzed. Pre-configured reports include Active Incident Reports, Incident Reports by Issue Type, and Incident Reports by Department.
  • Part 11-Compliant Features: MasterControl provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy the FDA’s 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.
  • Unparalleled Validation Features: To better meet the needs of companies in regulatory environments, the MasterControl validation approach dramatically cuts the time, pain, and cost involved in validation. MasterControl's continuum of innovative validation products and services include MasterControl Transfer OQ™.
  • Product Training: MasterControl’s Professional Services team has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster. The team conducts training at MasterControl’s state-of-the-art Education Center in Salt Lake City and also at customers’ facilities.
  • Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer’s needs, from initial installation to regular maintenance.

About MasterControl

MasterControl Inc. produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company’s critical information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit www.mastercontrol.com, or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); or 03-6801-6147 (Japan).