Automatisierung von Risikomanagement und -bewertung mit MasterControl Risk™-Softwaresystemen

Ein einheitliches Konzept für die Bewertung und das Management von Risiken ist für ein umfassendes Qualitätsmanagement unerlässlich. Das Risikomanagement-Softwaresystem von MasterControl ist eine integrierte Softwarelösung, mit der Unternehmen wiederholt auftretende Probleme nachverfolgen und analysieren und damit Systemrisiken auf lange Sicht ausmachen und eindämmen können.

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MasterControl's Risk Software can Help You

MasterControl Risk™ is a "one-stop shop" that unifies all risk-related activities and documentation in a single, centralized repository. The MasterControl risk management software system provides a complete and accurate picture of the risk landscape across product lines, business processes, and business units, precluding reputation damage from recalls or regulatory action.

These examples demonstrate how MasterControl's risk management system helps companies efficiently manage consistent risk evaluation and mitigation processes:

Risk Management Challenges

MasterControl Risk Management Solutions

Disjointed Risk Systems:

A lack of standard risk management analysis methodologies and assessments results in enterprise-wide waste of time, money, and resources.

Integrated Risk System:

MasterControl brings together all risk management related documentation in a single location. MasterControl's risk management system has scheduled reporting and full search capabilities to provide insight and easy access into risk assessment and mitigation activities.

Inconsistent Risk Assessments:

In environments where risk assessments are performed but are not standardized, risk evaluations may vary from one assessor to the next. Whether an appropriate action is taken depends on the particular assessor, meaning that similar issues may end up being treated differently.

Standardized Risk Analysis Process:

MasterControl's risk management software insures that a single system is being used to collect and manage risk management related activities. The system guarantees that corporate risk tolerance thresholds are employed and followed for risk-related activities across the enterprise. When used in tandem with MasterControl Process™, standardized risk calculation tools and methodologies can also be implemented.

Disconnected Risk Processes:

The use of manual systems typically results in the creation of separate data repositories (e.g., risk analyses and corresponding CAPAs), making it difficult to track and record comprehensive documentation.

Connected Risk Management Processes:

MasterControl provides employees from different departments with a simple and efficient method for participating in risk assessment and mitigation activities. MasterControl's risk management software offers electronic workflows and signatures for execution, review, and approval of risk activities and documentation. Personnel can leverage a risk-based approach in multiple processes including CAPA, non-conforming material disposition, protocol development, supplier qualification activities, etc.

Benefits of a Risk Management System

  • Uniformity: MasterControl risk management systems gives quality and regulatory departments uniform methods to perform consistent risk analyses. Engineering and manufacturing personnel can easily document and store risk mitigation activities in product and process design.
  • Risk Assessment Capabilities: Users can configure multiple risk types for evaluating different categories of operational risk. Risk assessments can be launched from anywhere within the MasterControl system to analyze hazards associated with any process or activity. MasterControl's best practice process also includes risk mitigation and reassessment.
  • Reporting Tools: MasterControl's risk management software has analytics reports that allow analysis of risk files and risk assessments. The system's scheduled reporting capability and intelligent threshold rules also increase management awareness.
  • Risk File Management: A single collection point for all risk-related activities pertinent to a given project, process, or supplier brings together risk assessments, documentation, and other risk management processes (FMEA, FTA, surveys, etc.). Risk files may be routed for approval and electronically authorized in accordance with 21 CFR Part 11.
  • Integration Points: Keywords are used to launch risk assessments from any MasterControl Process™ form (e.g., CAPA, NCMR, etc.). Risk files are associated with vendors stored in the MasterControl Supplier™ module to track risk-related activities. Risk assessments launched from an item (document, process, project, BOM, etc.) in any MasterControl module are automatically linked to related InfoCards in the MasterControl system.
  • Increased Management Oversight: The software's standard methodology simplifies the application of resources in the most risk-prone areas. The MasterControl's risk management software systems insures that organizational risk tolerance is not exceeded.