Two pairs of hands pointing at a complaint log on a digital complaint tracking system on a tablet

COMPLAINT MANAGEMENT

With an AI-powered complaint management system, you can quickly identify, investigate and resolve complaints to continuously improve product quality

Complaint Management Demo

Centralize the complaint handling process to increase control, lower risk and improve quality. TrackWise Digital enables organizations to manage complaint intake efficiently, conduct investigations, perform risk assessments, review reportability, complete corrective actions and trend complaint categories. Unlock data that will boost productivity, reduce investigation time and increase patient safety with complaint management software powered by AI technology.

Three business professionals sharing a tablet to easily view complaints

AI-Enabled Complaint Management

AI can significantly enhance life sciences complaint management by automating data collection and analysis through natural language processing and image recognition. It enables pattern recognition and trend analysis, predicting potential issues and prioritizing cases based on severity. Automation of routine tasks, decision support and compliance monitoring are facilitated by AI, allowing for more efficient handling of complaints.

Enhanced communication is achieved through AI-powered chatbots and continuous improvement is driven by analytics, providing insights for refining processes. Implementing AI in life sciences complaint management increases efficiency, improves decision-making and better regulatory compliance, ultimately enhancing customer satisfaction and product quality.

Learn About AI-Enabled Quality

What is a Complaint?

In 21 CFR §820.3(b), a complaint is defined as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution.”

About Complaint Management

Manage the entire complaint lifecycle—from investigation to resolution, and gain insights for continuous improvement.

Webinar

Improving Postmarket Surveillance Across the Life Science Value Network

Comprehensive Postmarket Surveillance is more than receiving complaints and reporting to Regulatory Agencies.

Blog

Post-Market Surveillance: UDI Compliance for Class I Devices Moves Forward with New Deadline

Class I and unclassified devices will now have to comply with UDI by September 24, 2022. However, the FDA will not enforce GUDID submissions—except for implantable, life sustaining or life supporting devices—until December 8th, 2022.

Datasheet

Complaint Management Datasheet

Manage the entire complaint process with TrackWise Digital.

Challenges of Complaint Management for Life Sciences

Life sciences manufacturers must deliver effective and safe products to the marketplace. Critical to this function is identifying product issues quickly and accurately before they lead to significant patient harm. Complaint handling is essential to this process, enabling a manufacturer to gather and investigate potential product problems and rapidly address those that present risk.

Because compliant handling requires the communication and collaboration of multiple stakeholders throughout a manufacturer’s operations, these groups and individuals cannot effectively resolve issues while working in silos. An enterprise-wide solution enables all parties involved in the complaint handling process to work effectively and efficiently to resolve product issues, save time and money, facilitate compliance, and safeguard patients.

Cropped shot of a nurse holding a senior woman's hands in comfort

Why Complaint Handling Is Important

How a life sciences manufacturer handles product complaints significantly impacts patient safety, operations and revenue. Those companies that can effectively manage complaints and address product issues promptly— can more easily comply with global regulations, protect patients from harm and avoid losses.

However, manufacturers with inadequate and inefficient complaint handling processes and systems face tremendous risks. Mismanaged complaints can swell into widespread issues that damage brands, profits and human lives.

A woman at her desk digitally intaking a complaint

Complaint Intake

Complaint handling is a crucial component of a successful QMS. A robust complaint handling system that receives sufficient information, triages, prioritizes, assesses, resolves and communicates the complaints promptly will benefit the company through customer loyalty, patient safety and total cost of quality.

TrackWise Digital® is a cloud and SaaS-based Quality Management System (QMS) that enables organizations to manage complaint intake efficiently, conduct investigations, perform risk assessments, review reportability, complete corrective actions and trend complaint categories.

Impact of Improved Complaint Management

Industry leaders who conduct a thorough analysis and reconsider crucial aspects of their Quality Management System (QMS), such as Complaint Management, will witness the following benefits:

Decrease in variations

Prevention of defects

Reduction in rework

Enhancement in productivity

Better utilization of resources

Achievement of transformation goals

Decrease in risk

Improvement in safety

Surpassing customer expectations

The Complaint Management Process

A likely driver behind regulatory compliance challenges in this area is the complexity of the complaint handling process. It requires significant coordination and collaboration throughout a manufacturer’s operations. Below are the primary steps in the process.

STEP ONE: COMPLAINT TRIAGE

STEP TWO: INVESTIGATION

STEP THREE: EXTERNAL REPORTING

STEP FOUR: RESOLUTION

ADDITIONAL STEP: INTERNAL REPORTING

Three coworkers collaborating on a tablet, phone and laptop to triage complaints

Customers, consumers and other parties report complaints to the manufacturer, often through various channels, such as calls/emails to customer service, calls/emails to sales reps and online portals. A group or individual must manage the incoming complaints, gather the necessary information and route them to the manufacturer’s quality team.

A group of workers in lab gear in a circle to discuss a complaint

The quality team must then investigate the complaints, classify them by severity level and prioritize based on potential risk. From there, they must identify the root problems/causes and establish and implement plans for resolution. Depending upon the type of issue (e.g., product, packaging) and required resolution, the quality team must notify and involve additional stakeholders (e.g., manufacturing and marketing teams).

Two business professionals discussing complaint management with an auditor outside of a building

Simultaneous with the quality investigation, the regulatory group must determine what information it needs to communicate with regulatory bodies, to which regulators based on where the product is sold, and the timeframe in which it must submit reports. The regulatory group must then report to regulators within their established timeframes.

Two life sciences workers in lab coats pointing at a computer screen to discuss a complaint

As a result of the complaint investigation, the quality team must determine whether a corrective action or preventive action (CAPA) is required to correct a product issue and prevent it from happening again. It must also follow up on whether the CAPA was effective.

Coworkers, some in scrubs and others in business suits sharing information on complaints

Throughout the process, a manufacturer must be able to generate reports on complaint handling for managers and executives, including details on the investigations, regulatory actions and CAPAs when applicable.

Process Breakpoints That Present Risk

Complaint handling requires extensive communication and collaboration among key stakeholders, enterprise-wide visibility and data sharing, and detailed complaint management and resolution documentation. Although complaint handling is a critical component of Good Manufacturing Practices (GMP), some manufacturers still use manual processes, disparate systems, and inconsistent workflows to manage it. As a result, manufacturers often experience breakpoints throughout the process:

delayed response

limited visibility of information

increase risks and costs

The Solution: Enterprise-Wide Complaint Management

Many life sciences manufacturers have implemented centralized, automated, and fully integrated quality management processes and reporting systems to manage complaint handling regulatory requirements and minimize non-compliance risks. These systems provide the organization with a consistent and standardized intelligent mechanism for recording, tracking, and trending customer complaints, investigations, and adverse event reporting according to regulatory standards.

Two business people sharing a tablet to view information about a digitally tracked complaint on a tablet

Key capabilities include:

The ability to record complaints and adverse events in a centralized location and track-and-trend issues to rapidly identify and address potential risks to patient safety
Patented business rules engine to determine the appropriate process steps for assessing and addressing the complaint and notify the necessary parties to begin an investigation
Automated process assigns complaints and related investigations based on manufacturing location and product type
Management of the complaint lifecycle via trending of real-time data and escalation of potential safety issues
eReporting capabilities that provide the required traceability of document acknowledgments between the FDA database and a manufacturer’s systems

Benefits of an Enterprise-Wide Approach

An enterprise-wide approach to complaint management enables a manufacturer to achieve compliance, reduce patient risk, improve product quality, streamline and centralize workflow, avoid litigation, and produce positive business outcomes.

A doctor in personal protective gear talking to a patient and writing down notes

Reduce Risk and Protect Your Brand

When all complaints are channeled through a centralized system, a manufacturer can quickly identify and address critical issues promptly. This allows companies to preserve brand reputation, maintain credibility in the eyes of the public, avoid negative publicity, and increase customer satisfaction.

Three life sciences workers in lab coats pointing at a computer screen to discuss a complaint

Standardized workflows help ensure all steps in the process are completed and minimize the chance that critical information or tasks will be overlooked. This standardization also enables timely and accurate complaint and adverse event assessments, structured root cause analyses and appropriate CAPAs.

Business woman smiling while able to review a complaint on the go with her tablet

With an auto trending capability, the system can automatically detect developing trends and escalate them to management. Using the system, staff can generate custom reports on complaints, trends and closure times and share this information with management/executive team to facilitate knowledge-driven strategic decisions.

A lab worker in a manufacturer room writing down notes

Comply with Regulations

With an enterprise-wide solution, all manufacturer locations use the same system and standard processes and workflows to handle complaints, facilitating compliance with GMPs and government regulations in the U.S. and abroad.

Auditors meeting over coffee in a lobby to discuss complaint management compliance

Information is immediately captured and input into a strict, pre-set, government-compliant system with clear standard operating procedures (SOPs) and full audit trails. System controls reduce the risk of unauthorized individuals accessing protected health information (PHI) to satisfy HIPAA. Furthermore, the electronic information captured throughout the complaint handling process supports accurate and timely reporting to the FDA and other regulators.

Two coworkers thoughtfully sharing information on complaints on a laptop

Streamline Operations and Reduce Costs

Process automation and standardization drive greater efficiency throughout the complaint handling process. Using a system that integrates seamlessly with other business-critical systems (e.g., CRM, ERP, EDI), every department involved in the complaint handling process can electronically share information, which minimizes manual data entry and eliminates the need to merge/reconcile data housed in spreadsheets or discrepant systems.

Life sciences workers in lab coats smiling and sharing complaint management information on a tablet

Using standardized workflows and terminology, from complaint capture to closure, facilitates greater efficiency, consistency, and precision throughout the process and across the organization. This helps drive rapid response and closure times, resulting in streamlined operations and cost reduction.