To manage regulatory requirements, companies in government regulated industries — especially life sciences — need an enterprise resource planning (ERP) solution that includes integrated functionality to foster compliance. Managing government regulations is mandatory and becoming increasingly more challenging and expensive, requiring constant observation to ensure that processes do not get disrupted and expose the company to unnecessary threats.

Sage Enterprise Management (Sage X3) automates your incident management processes, including task assignments, investigation documentation, and corrective and preventative actions (CAPA). The system also tracks and manages the execution of CAPA plans, provides continuous traceability to related processes, and automatically sends approval requests to managers.

What should you consider before implementing Sage Enterprise Management to manage your CAPA plans and conduct more effective failure investigations? Here's insight on integrated production controls in Sage Enterprise Management.

Your People and the Process

What are the people in your receiving inspection area documenting in the ERP system? What are the quality indicators that are being captured? Having your work orders integrated into Sage Enterprise Management will allow you to do the following:

• Identify the individuals in the process.
• Capture the step-by-step process for performing the operations and document them in the work order.
• Capture and ensure the work performed is documented accurately.

Your Current Approach

Sage Enterprise Management will allow you to capture the workflow occurring in the manufacturing process, including specific requirements and critical-to-quality (CTQ) steps via technical sheets. Consider design development activities related to the manufactured item, as well as, modifications during the manufacturing process that may be important to the final output.

Existing Technology / Machinery

Identify any special equipment, computers, scanners, and tools required to complete the work. View equipment and tool calibration and maintenance records before getting started.

Necessary Materials

What raw materials, consumables, and other items did you use to construct the final product?

Desired Data and Analytics

What metrics can you generate from the processes used in quality evaluations?

Your Current Business Environment

Identify the conditions for all operational processes, including location, time, temperature, and culture.

Sage Enterprise Management provides real-time visibility into production processes, giving you a competitive advantage with the ability to immediately address issues before they progress.

For more information on the Sage Enterprise Management platform and how it can help you manage your incident management processes, contact Southeast Computer Solutions today.