At some point, all organizations inevitably face issues related to product complexity, organizational inefficiencies, supply chain management and outsourcing, as well as internal and external risk in their operational activities. Furthermore, an increasing number of regulatory mandates and more active involvement among shareholders are prompting organizations to focus their efforts more closely than ever on identifying areas of potential risk across their enterprise.
By implementing an integrated Risk Management solution enterprise-wide, organizations can reduce the potential inefficiencies that result from unanticipated operational disruptions and evolving regulations and restrictions. Such a solution ultimately promotes healthy operating margins, process efficiencies, quality and compliance, and overall profitability.
Pilgrim Software’s Risk Management Platform
Pilgrim Software’s platform provides a means for documenting and assessing risks, defining the required controls, managing assessments and audits, identifying issues and implementing recommendations and remediation plans in a centralized and coordinated manner. Pilgrim helps maintain best practices and compliance with ISO 14971, ICH Q9, ISO 31000 and other critical compliance and operational mandates to ensure manufacturers remain a preferred supplier to their customers.
Pilgrim’s Enterprise Risk Management provides a framework comprised of three steps for controlling risk:
- The identification, quantification and prioritization of risks across the enterprise
- Examination of the controls needed to successfully mitigate the risks identified
- Identification of processes to control the losses after the adverse event
Risk Assessment and Analysis
Pilgrim Software’s solution provides a centralized risk framework to document and manage all risks faced by an organization. The solution can be configured to enable the customer to even categorize the risk factors and have different risk collection forms for different forms of risks. The application framework supports risk assessment and computations, giving a clear view into an organization’s risk profile and enabling managers to prioritize their response strategies for optimal risk/reward outcomes.
Risk Planning and Review
Pilgrim’s enterprise risk management solution integrates with its document management solution to allow a company to define a risk plan, process and controls. Using Pilgrim’s solution, a manufacturer can easily implement its own risk plan, policies and procedures. Capabilities within the solution to execute them and regularly review their effectiveness include consistent and highly visible documentation, the tracking of events in real time to drive risk evaluation, and the enforcement of standardized processes and effective enterprise-wide communication.
Executive dashboards provide enterprise-wide visibility into the risk management process and highlight issues that need to be addressed. The solution has the ability to track risk categorizations, control ownership, assessment plans, remediation status, etc., on graphical charts that can be accessed globally and display real-time information. Ability to drill-down provides an easy way to access the data at finer levels of detail.
- Applying Risk Management Across the Products & Operational Value Chain
- How to Meet Emerging Risk Management Expectations
- How to Put Management Back into Risk Management
- Moving from Risk Analysis to Risk Management
- Using the Right Tool for the Job in Risk Analysis & Management
- Building Risk Assessment Strategies for IT and IT Quality
- Supply Chain Risk Management
- SIT UP AND PAY ATTENTION: Product Liability is Both a Legal and QA Concern