Pharma/Bio Organizations know that complaints from their patients, doctors, distributors, consumers, customers or retailers create severe brand and reputational risk. Failure to meet quality standards will result in returns, recalls, and batch wastage, all impacting the bottom line. But more importantly, adverse events create a serious risk to patient safety, can destroy the organization’s reputation and kill the product and/or the company. Patient safety is taken seriously by every Life Sciences organization and so every complaint must be properly handled.
By implementing an automated Complaints Management Solution, the organization can ensure that all complaints are captured, investigated and tracked to resolution, to the satisfaction of all stakeholders, including the regulatory agencies. By being able to conduct trend analysis of complaints in one facility, preventative actions to be put in place in other facilities, ensuring that the same issues are not repeated elsewhere.
Automated forms, business rules and a dynamic workflow engine make up the basis of the QUMAS best practice Complaints Management Solution process, allowing for an action plan to be created and executed to the satisfaction of the complainant. Correspondence and audit trails are continuously recorded throughout the process so that all stakeholders are continuously aware of the status of the complaint. The ability to deliver a preconfigured report on the issue also removes the scramble to gather information necessary in making sure regulatory agencies are kept up to date.
For more information on managing Complaints 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 Complaints, CAPAs, Deviations, Change Control and Audits:
- Complaint and Deviation creation
- Form filling, workflow execution
- Root Cause Analysis
- QA Approval