Market Complaints Management and Tracking Software
In the Life Sciences Industry, Customer Complaint Handling procedures are considered as a requisite of Good Manufacturing Practices. Typically, the Market complaints are related to defective or ineffective medicines. Immediate attention must be paid to these complaints with complete evaluation and action to prevent a recurrence.
Pharmaceutical and Biotech companies must demonstrate strict adherence to the requirements outlined in current Good Manufacturing Practices (cGMP) keeping in mind the processes and control which govern product manufacturing in the pharmaceutical and drug Industry.
Problems with current Customer complaints handling in a GMP Environment
- The manual market complaint handling procedures are a fragmented process. Departments end up working with incomplete information because of detachment among the departments.
- A part of the complaint process will be handled by a person while another part is handled by an investigator who may not have all details of the complaint. Working with a manual process, cluttered with open applications, slows down complaint resolution, and leads to inconsistencies in handling complaint resolution.
- With changing consumer demands, the number and complexity of products have increased. Existing manual systems do not offer the flexibility required to stay ahead in a highly competitive environment.
- In a global company where customers, partners, and colleagues are geographically distributed, the need for collaboration is important. The lack of a common integrated system hinders the complaint investigation process because information does not flow easily from one person to another.
- There is no real-time view or track of the complaint’s current status.
- Continuous changes in regulatory factors require organizations to adapt rapidly. Without an automated system that manages complaints, organizations have to overcome several challenges to implement changes easily in order to stay at par with regulatory requirements.
- Failure to provide a timely report or follow compliance standards leads to missed market opportunities or hefty fines from regulatory agencies.
Market Complaints Software is developed on LOW CODE PLATFORM, automates the handling of complaints from initiation, acknowledgment, regulatory reporting, and investigation through a root causes analysis, to conducting assessments, and obtaining closure for any associated CAPA.
At the Present time, Pharmaceutical manufacturing, Biotech, and Life Science companies steer ahead in an intensely competitive world if their Compliant Management System is automated.
AmpleLogic Customer Complaints Management Software solution allows the complaint to be reported from anywhere through its web-based interactions, in addition to allowing the inflow of complaints through traditional methods such as phone and e-mail.
Reported complaints are immediately triggered into investigations and assessments along with pre-defined reporting recommendations that guide the reporting to the regulatory authorities. Pre-defined responsibilities, fast-paced investigations, elaborate assessments, and effective CAPAs drive organization success through a shortened complaint handling processes and better closure timelines.
Features of the AmpleLogic GMP Complaints Management Software
Simplified Market Complaint Reporting
By simplifying the process of reporting a complaint or adverse event with the help of pre-defined fields which, the customer or distributor is able to easily report the complaint allowing the organization to respond quickly and prevent problems. Additionally, by obtaining complaints through different sources like the web, phone, and email, organizations can ensure early complaint identification.
Robust Root Cause Analysis
With the help of the root cause analysis functionality, tasks are assigned to investigators and employees across the departments based upon the criticality of the complaint. These investigators, in turn, can create tasks and send them to participants in a response. The responses are evaluated for the identification of root cause and submitted for the proposed CAPA . Due dates are set to for every task to make sure that the tasks are completed in a timely manner. Any task which is over-due can be escalated automatically to keep the system efficient and productive.
This feature provides the list of reporting actions applicable to the typical market complaints which form recommendation criteria for what to be reported and which regulatory agency to be reported to. This automates decision making which in turn, improves the response time with auto-generated reports that can be sent to concerned authorities directly through the system.
Customer Complaint Severity
Classifying a Customer complaint determines the extent of adversity of the complaint and how quickly an organization needs to resolve the complaint. This also automates the appropriate reviews across workflow steps and notifies them as pre-defined.
Market Complaints Repetition in GMP environments
By evaluating a complaint for its repetition in the recent past makes it is easy to review previous actions and improve the investigations. Repetitive complaints must be reviewed by the management through the dashboard and corrective actions must be taken accordingly.
Market Complaints Software- Integrations
With cross-functional workflows that move through quality systems and loop back, it is an essential need to make the interface as user-friendly as possible. The Market Complaints Management Software allows a swift switching between quality tools or programs by using a single, integrated platform for all quality systems.
Integrated Quality Systems
The AmpleLogic GMP Complaints Software is designed to be flexible in integrating with other quality systems and establish a seamless and controlled flow between change control and the rest of the quality systems, especially CAPA Software. The CAPA activities related to change control can be initiated, evaluated and implemented in Change Control System.
Alerts and Notification sent Automatically
Adverse event Tracking using Customer Complaints Software improves the efficiency with which complaints are handled by automating alerts and notifications send to the employees working on the compliant. These communications are designed to be sent at pre-defined frequencies and specific workflow steps to remind users of the target date and required actions. Notifications are sent directly through follow-up emails that are sent automatically to the user’s e-mail account. The system also auto escalates overdue tasks to help resolve the issue in a timely manner.
Benefits of Complaint Management Software
- Global web accessibility of Market Complaints Software will be 24 x 7 to intake the complaint and respond immediately.
- Compliance with 21 CFR part 11, EU Annex 11.
- Comprehensive in defining complaints through logical data capture that enables clear understanding of the investigations or assessments.
- Repetitive evaluation to identify links of current complaints to past complaints and respond with improved corrections.
- Complaint Management Software auto escalates in the event of a change of complaint into adverse events.
- A single, centralized platform which enable the tracking of complaints even from multiple locations.
- Changes can be tracked easily and all complaints can be tracked live with status, automated alerts, and notifications.
- Metrics reports or trends are exclusively analytical and visually eye-catching.
AmpleLogic GMP Compliant Software also complies with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.
Other industries that can benefit from our Customer Complaints and Adverse events Tracking Software
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages