Ask the Expert

Complaint Handling, Compliance Drivers & Vetting Vendors

FDA inspectors are likely to focus more on drug and device company complaint-handling efforts in 2007 because they are tied so closely to patient safety, Sparta Systems VP of Marketing and Product Development Steve Cagle recently told PIR. He also addressed how FDA-regulated life sciences companies should inspect potential vendors and whether business or regulatory factors should drive compliance efforts.

PIR: Just how important do FDA inspectors consider proper complaint handling?

Cagle: From our experience, we find proper complaint handling continues to be a key FDA concern. A complaint indicates a quality system breakdown and, as a result, a product that does not meet quality standards has slipped through the cracks. It also means that a consumer or patient may have experienced an adverse reaction as a result of the quality failure.

Structured complaint investigation and resolution processes are required to ensure the cause of the issue is discovered, and appropriate action is taken. Failure to do so leaves other customers at risk. As a result, we feel that FDA scrutiny of complaint systems will only increase.

PIR: How can regulated companies be more proactive in this area rather than waiting to put out fires?

Cagle: Some software systems provide functionality, which allows a company to be proactive with its complaint handling. For example, certain software packages provide automatic trend detection based on configurable escalation parameters. For instance, the company may define an alert to occur if there are more than ‘X’ number of complaints for a given product type in the last ‘Y’ days. Some systems also email reports to management based on pre-defined schedules in addition to providing executive dashboard tools. Automated tools such as these provide visibility to systematic problems as they develop, alerting managers to take action before issues becomes “fires.”

PIR: When it comes to addressing compliance issues, we have heard some debate about whether you start with regulatory or business goals as the initial driver. What is your take?

Cagle: If a company is out of compliance, then naturally, bringing its systems into compliance is its first priority.

At the same time, business goals must also be key drivers for improving systems. Many companies have compliant systems, which they get by on, however the processes or software packages they use may be inefficient or not scaled for growth. Inefficient systems hide problems in addition to wasting the organizations’ money and resources.

PIR: How should FDA-regulated life sciences companies best vet vendors in this space? What should they look for?

Cagle: Companies should evaluate vendors based on their intrinsic capabilities, experience and track records. Companies should consider how well the software integrates the complaint process into the broader quality management system. They also should assess the extent of configurability the software provides.

Best practices, the vendor’s overall implementation experience and the product’s maturity are also important.

In terms of functionality, reporting is one of the most important elements of a complaint system, since trending of complaint data is a key quality management function. Companies should look for systems with easy-to-use search tools and built-in, enterprise reporting packages.