Change Control Software

The three key challenges facing Pharmaceutical and Biotech Organizations today in relation to change management are:

  •  Assessing the impact of product and process changes across functions
  •  Executing product and process changes with clear definition of roles & responsibilities
  •  Identifying the right measures that drive the desired behavior, business performance and outcomes

By utilizing the automated Change Control Solution from QUMAS, Pharmaceutical and Biotech Organizations can meet these challenges head on. By conducting a detailed Impact Assessment and getting feedback from all parties involved, the implementation phase of the change will be more effective.

An effectiveness review at the end of the process will ensure that the change control met its goals of completing the change as initially requested and will also ensure that all the supporting information is correctly captured. Change Control Trend reports provide a full 360 degree view on the patterns and trends that will help the organization improve its change control process.

For more information on managing Change using the QUMAS solution, download this webinar on Driving Business & Quality Success with an Integrated QMS Platform, which outlines how to take control of your quality processes including Change Control, Complaints, CAPAs, Deviations and Audits:

  • Creating a Change Control
  • Form filling, workflow execution
  • Impact Assessment
  • QA Approval

Alternatively, check out this Change Control Process Package from the QUMAS Packaged Solutions, which offers an off-the-shelf approach to Change Control Management.