Complaints Management - Medical Devices, Pharma, Healthcare Companies

Inadequate handling and management of Product complaints is one of the top findings in the FDA warning letters to the Pharma and Healthcare companies. Though these companies have Complaint Management systems and procedures in place but clearly there is a need for robust solution to meet the challenges of regulatory compliance, having an advance alert mechanism for relevant business decisions on account of product safety and most importantly of being responsive to customer and regulatory authorities.

The Complaint Management encompasses two major parts a) Logistics complaints consisting of damaged goods, wrong shipments, product returns, wrong invoice, etc and b) Complaints arising from Adverse drug effects, Side effects, Interactions with other drugs. These are collectively known as Adverse Drug Events (ADE) and can be fatal for the consumers. The ADEs if not managed well could result in severe consequences from warnings,marketing suspension,fines,product recall,litigation and thus effecting life-sciences companies in more ways than one.

To make the Complaint Management solution robust and agile, let us review the overall process & process steps:
a) Complaint Registration
b) Complaint Assignment and Processing
c) Root Cause Analysis including Corrective Action and Preventive Action (CAPA)
d) Reporting ,Alerts,Trending and Communication
e) Complaint Closure
f) Proactive Monitoring

The weakness in the above process management can be many. The underlying technical systems are low in technical and business value and require multiple manual interventions in the complaint life cycle. The systems are managed on regional basis and thus lack to give a global view of complaints on a given product. The integration between the systems catering to different parts of complaint stages may be missing totally or partially and thus inducing the delay in tracking and monitoring of complaints. The analysis of adverse drug events will involve multiple departments e.g. Quality,Research & Development,Product Life Cycle management teams and the complaint system should facilitate collaboration amongst various teams involved. Because of mergers and acquisitions it is quite likely that complaint handling process is not consistent across the organization.

It is critical for Pharma companies to have a standardized process for Complaint Management which is supported by solution advanced in both technology and functionality to meet the above challenges. The salient features of an effective solution are listed as follows:

• Web based application catering to all stages of Complaint life cycle
• Capability for Workflow, Alerts and Notifications
• Auto routing of Complaints
• Ability to manage documentation and attachments throughout Complaint life cycle
• Internal and Customer view of Complaints
• Tracking & Monitoring of Complaints
• Complaint Escalations
• Single database for all Complaints
• Multiple language capability
• Electronic Signatures and Audit Trail
• Integration with Enterprise Applications (ERP) , Quality Management, Product Life Cycle Management applications
• Integration with Adverse Event handling process
• Collaborative framework to manage complaint process across cross-functional departments
• Regulatory and Internal Reporting,Trend Analysis
• Minimum manual intervention
• Scalable Technical Architecture
• High Performance and Response times
• Security & Authorization for relevant access control

Apart from increased customer awareness and because of ever rising regulatory and market pressures on Pharma industry, there is renewed focus on Complaints Management.Pharma and Healthcare companies should review their Complaint Management processes and systems to incorporate the required capabilities that arenecessary to meet current market challenges.

A robust and effective solution will not only help in reduction of cost of compliance but will also result in increased customer loyalty through improved response times and better customer experience