Market Complaints Record, Management and Tracking Software
AmpleLogic Market Complaints Management and Tracking System coordinates and handles initial complaints, acknowledgments and appraisals, regulatory reporting, investigations through root cause analysis, assessments and ensures closure with any associated CAPA. It is no secret that the world has evolved and at this time, pharmaceutical manufacturing, biotech, and Life sciences are a step ahead in a very competitive market when their complain management system is fully automated.
This Market Complaints Tracking Solution allows complaints and ideas to be reported easily from anywhere around the globe. It is fully equipped with web-based interactions and allows conventional modes of communication like phones and e-mails. This ensures proper circulation of information between clients and companies, between companies and regulatory bodies.
When reports are made via this tracking software, investigations and assessments are immediately carried out and an effective CAPA System corrects these errors, preventing any form of future recurrence. If this issue needs to be reported to appropriate regulatory authorities, provision is made for pre-defined reporting recommendations.
Features of the AmpleLogic Complaint Management System
The system makes it easy for the complainant to define the complaint comprehensively with pre-defined fields. It ensures that complaints are reported in-time allowing the organization to respond quickly and prevent or control adverse events. Besides, the diversified capture from sources like web, phone and e-mail make it easy and swift for complaint identification.
Robust Root Cause Analysis
The Root Cause Analysis allows tasks and complaints assigned to the investigators and across the departments based on the severity of the complaint. The feature places the more pending and severe complaints on top for investigators to treat. These investigators, in turn, can create tasks and send them to participants for appropriate responses. These responses are in turn evaluated for identification of root cause and submitted for CAPA approval. Due dates set ensure targeted closure of tasks and auto-escalation upon overdue maintains the nature of the Root Cause Analysis to be robust and effective.
Via thorough market evaluation, this feature provides the list of reporting actions applicable to the typical market complaints. This forms recommendation criteria for what to be reported and helps in determining the appropriate regulatory body to be reported. The relevance of this is that decision making is automated which improves efficiency and response time. Auto-generated reports can also be sent to concerned authorities directly through the system.
Classifying a complaint determines the adversity of the complaint and how quickly an organization needs to resolve the complaint. Reviews are also automated with appropriate workflow steps and pre-defined notifications.
Complaint Repetition allows for the repetition of unresolved issues to be resolved and stores these issues to prevent recurrence and improve investigations. This feature helps to review past complaints to help solve present or future ones. All complaints can be responded with effective corrective and preventive actions with continuous improvement.
Quality Systems Switch
With cross-functional workflows that move through quality systems and loopback which is essential to make the interface as user-friendly as possible. The Market Complaints Management Software allows a swift switching between systems with the harmonized single user-interface across all quality systems.
Integrated Quality Systems
AmpleLogic Market Complaints Management system is designed to be flexible in integrating with other quality systems and establish a seamless and controlled flow between all quality systems especially CAPA Management. The CAPA activities related to change control can be initiated, evaluated and implemented at Change Control System.
Automated Alerts & Notifications
Users are automatically communicated at defined frequencies and at defined workflow steps about the approaching target dates for required actions. Users are notified directly through follow-up e-mails that are sent automatically to the user e-mail account. Besides the system auto escalates the overdue and helps resolve the issue.
Benefits of Complaint Management Software
- Global web accessibility of Market Complaints Management Software allows for 24-hour intake of complaints, ensuring immediate response.
- Utter compliance to set standards by 21 CFR part 11 and EU annex 11.
- Logical data capture ensures comprehensive definition of complaints. This ensures a vivid understanding of complaints and across investigations or assessments.
- Repetitive evaluation aids to track current complaint to past complaint and respond with improved corrections.
- Centralized repository to track complaints across multiple sites.
- Allows for effective communication and information via live tracking and traceability of changes with status, automated alerts, and notifications
- Metric reports are made analytical, carried out with appropriate diagrams and colors to be made visually appealing and understanding