Poor handling & management of product complaints is one of the common findings in the FDA warning letters to the Pharma and Healthcare companies. In Pharma and Healthcare industry the need to effectively manage complaint cycle is indispensable because minor quality defect can cause safety issues and even death.
Pharmaceutical and Healthcare companies need to fulfill complex quality and regulatory guidelines of multiple authorities of multiple countries which guarantees about the superior quality of drug to the global users. In spite of these measures there is a chance of critical, major and minor quality defects like adverse effects, packaging related complaints, complaint related to labelling / coding of batch details, shortages, extraneous contamination, mix-ups, etc.
Most of the companies are still relying on Excel spreadsheet or home grown system but this is not viable solution to address modern quality requirements.
QEdge market complaint management software have been developed specially for Pharmaceutical and Healthcare industry players where they can log, investigate, analyze, verify and validate complaints with the objective of enhancing quality standard. QEdge- complaint management software is a web based solution empowers you to streamline, automate and smooth your complaint management practices, shorten complaint management cycle which ultimately increases customer satisfaction and brand reputation.
QEdge centralize all your complaint management activities like log, investigation, CAPA applied , analyze and closure very helpful for quick management review and store and create a central repository or FAQ’s for further learnings.
QEdge-complaint management software also provide you the flexibility to design your own process as per your SOP and you can reap various benefits like:
• Total compliance with 21 CFR part 11
• Centralized repository to track complaints across multiple sites
• Web based solution allow you to access complaint management system 24*7
• Customizable workflows to suit your current need
• Ability to integrate and establish with other quality management systems
• Fast paced investigations with robust root cause analysis tools
• Capability to produce eye catching reports metrics for management review
• Quick response time which improve your brand image
• Enhance transparency, productivity and quality