Market Complaints Management

Current Problems with Customer Complaints handling in a GMP Environment

• The manual market complaint processing methods are disjointed. Departments end up operating with inadequate information as a result of departmental detachment
• A portion of the complaint process will be treated by one person, while the remainder will be handled by an investigator who may not possess all the facts of the complaint. Operating with a manual process that is jammed with open applications slows down the process of complaint resolution and causes discrepancies in complaint resolution processing
• The volume and complexity of products have grown in response to shifting customer expectations. Current manual systems do not provide the flexibility needed to stay ahead in a highly competitive industry
• When clients, partners, and coworkers are all located all over the world, a company’s need for cooperation is fundamental, and because information can not be transferred easily from one person to another due to the lack of a unified integrated system, the complaint investigation process is affected
• The complaint’s current status cannot be viewed or tracked in real-time
• Organizations must react quickly to changes in regulatory variables that occur on a regular basis. Without an automated method for handling complaints, companies have several difficulties when trying to implement changes and meet regulatory requirements
• Inability to submit a report on time or to adhere to compliance requirements results in a loss of market opportunities or costly sanctions from the regulatory bodies

Features of the AmpleLogic GMP Complaints Management Software

Simplified Market Complaint Reporting

By making it easier for customers and distributors to submit a complaint or an unfavorable incident through pre-defined fields, the organization will be able to respond faster and avoid complications. Furthermore, by collecting complaints from several channels such as the web, phone, and email, companies get customer complaints easier and earlier.

Robust Root Cause Analysis

Tasks are allocated to investigators and personnel from various departments based on the criticality of the complaint with the aid of the root cause analysis feature. In turn, these investigators can develop tasks and distribute them to participants in response. The responses are assessed to identify the root cause, and submitted for the planned CAPA. To ensure that tasks are done on time, deadlines are established for each one, and to ensure the system remains efficient and productive, every overdue task can be automatically escalated.

Regulatory Reporting

This feature gives a list of reporting actions that may be taken in response to common market complaints, including recommendation criteria for what should be reported and to which regulatory body. This automates decision-making and speeds up response times by automatically generating reports that can be forwarded to the appropriate authorities.

Customer Complaint Severity

The classification of a Customer complaint is used to determine the severity of the complaint and how urgently it needs the attention of the organization. The appropriate workflow reviews and notifications are also automated by this program.

Market Complaints Repetition in GMP environments

An easy way to review previous actions and improve investigations is to evaluate a complaint based on how often it has been brought up recently. Management must examine the dashboard for recurring complaints and take appropriate corrective action.

Complaint Management Software- Integrations

Making the interface as user-friendly as possible is critical for workflows that move through quality systems and loopback. Using a single integrated platform for all quality systems, the Market Complaints Management Software makes it easy to switch between quality tools and programs

Integrated Quality Systems

The AmpleLogic GMP Complaints Software is intended to be adaptable in terms of integrating with other quality systems and establishing a seamless and controlled flow between change control and the rest of the quality systems, particularly CAPA Software. The Change Control System can initiate, evaluate, and implement CAPA activities related to change control.

Send Alerts and Notifications Automatically

Adverse event tracking with Customer Complaints Software enhances complaint handling efficiency by automating alerts and notifications sent to the personnel working on the complaint. These communications are intended to be sent at pre-determined intervals and at particular workflow steps to remind users of the deadline and procedures to follow. Follow-up emails are sent automatically to the email accounts of users as notifications. In addition, the system automatically escalates due tasks to ensure they are resolved as quickly as possible

Advantages of Complaint Management System

• 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.
• The Complaint Management System extensively defines the complaints through its logical gathering of data, which allows for a clear comprehension of the investigation or evaluation carried out
• Continual evaluation to establish relations between current and previously lodged complaints, and respond with better corrections.
• The Complaint Management Software automatically escalates a complaint when it degenerates into an adverse situation.
• It is a centralized system that allows users to track complaints from different locations.
• It is easy to track and monitor all complaints in real-time with status, automated alerts, and notifications.
• Metrics reports and trends are strictly analytical and visually appealing.

AmpleLogic GMP Complaint Management Software is also compliant with electronic record standards as defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.

Other industries that can take advantage of our Customer Complaints and Adverse Event Tracking Software include:

• Pharmaceuticals
• Biotechnology
• Biologics
• Generics
• Contract Development and Manufacturing Organization (CDMO)
• Medical Devices
• Chemical Industry
• Contract Manufacturing
• General Manufacturing
• Contract Research Organization (CRO)
• Food & Beverages

For more information on how AmpleLogic Market Complaints Management System can benefit your company, please contact us.