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Best Practices for Complaint and Adverse Event System Implementation


Learn why postmarket surveillance is important in the life sciences industry and how to put a successful system in place.

Complaint and adverse event reporting help ensure the quality, safety, and efficacy of products after they’re placed on the market. This happens through post-market surveillance (PMS).

PMS is a regulatory requirement that involves collecting and analyzing product data to identify and mitigate risks. In the United States, it’s regulated by the Food and Drug Administration (FDA). In the European Union (EU), it’s regulated by the European Commission.

Apply these best practices to help optimize and automate your complaint and adverse event processes and make your PMS program a success.

1. Get buy-in from upper management

Critical stakeholders need to grasp the importance of a complaint and adverse event reporting system. They need to know what results are expected, like efficient data collection and improved metrics. They should also be aware of the cost and resources required.

2. Identify the pain points of complaint and adverse event reporting

An overwhelming backlog, late reporting, and inconsistent data capture and coding can expose your company to liabilities. There is a need for better data capture and standardization to facilitate data analysis and ensure accurate reporting.

3. Define the current situation, issues, and opportunities

Document the as-is state of your current reporting system. What is your volume of activity? How long does it take to process complaints and adverse events? How many employees do you have (or do you need) for reporting? Do your employees have the expertise to analyze data? Do you have the necessary systems for compliant PMS processes?

4. Conduct an extensive data review and cleanup prior to data migration

Find and fix any missing, inaccurate, or duplicate data in your existing system. Develop a strategy—that doesn’t involve manual data entry—to migrate data to the new system. Consider automating data conversion using an ETL (extract, transform, and load) process.

It’s important to know when data can simply be copied from one system to another (i.e., addresses) and when data needs to be transformed (i.e., data coding). ETL testing ensures that data is accurate after it’s loaded into the destination system.

5. Know how much historical data is required

Think critically about what data requires conversion. Regulatory authorities have different lookback requirements (e.g., the number of years records must be maintained); therefore, migrating historical records beyond the lookback requirement is unnecessary.

6. Automate intake from various sources

Choose a complaint and adverse event reporting system that enables you to automate intake from various sources like spreadsheets, phone calls, texts, emails, and social media. Your system should have language support to ingest data and streamline the triage process.

7. Capitalize on system capabilities

Drive efficiency with digital transformation and process improvements. Enhance operations and outcomes like compliance, processing time, data analytics, trend spotting, product improvements, patient safety, and cost savings. Explore the benefits of automating your PMS workflows with ProcessX, built on the ServiceNow platform.

8. Consider outsourcing to a knowledgeable third party

To optimize processes and maximize your complaint and adverse event reporting efforts, try outsourcing. You’ll get a dedicated team that knows the ins and outs of your system. Or they can help choose the right system for your organization.

How USDM Can Help

Qualified post-market surveillance specialists from USDM are ready to establish a system that’s right for your organization. 

For example, ProcessX is a validated GxP platform that automates processes, including adverse event management. It uses artificial intelligence (AI) and machine learning to categorize and assess risk during adverse event intake. Natural language processing (NLP) redacts personal information based on permissions. Generative AI analyzes large datasets and non-structured outputs to compile reports. 

The adverse event workflow in ProcessX enables you to gather information about the patient, the reporter, the product, and risks. This information helps to determine if the adverse event could be related to an intervention and whether it should be reported to the FDA. 

Using ProcessX, adverse events are consolidated into a single platform, repetitive tasks and data entry are automated, and you’ll achieve greater efficiency and cost savings. 

Whether you need to outsource your entire complaint and adverse event reporting process or get caught up with your backlog, contact USDM to find the best services and solution for your organization.  

USDM services include: 

  • Investigating, coding, and processing complaints and adverse events 
  • Establishing corrective and preventive action (CAPA) system procedures 
  • Performing root cause analysis 
  • Conducting medical device incident reporting 
  • Addressing EU MDR requirements 

Ask us about other services like GxP technologies and organizational change management. 

Read the case study: A global medical device company was able to address an FDA consent decree and tackle a complaints backlog of over 600,000 service orders. USDM developed a sustainable process to help the customer reduce the time it takes to process, code, and close out complaints.

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