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Technology Matters: How the Compliance System Can Guide You Through the Recall Process

Emily Ysaguirre
by Emily Ysaguirre on Wed, Jan 13, 2016

Technology Matters: How the Compliance System Can Guide You Through the Recall Process

A recall diminishes consumer trust and can affect brand integrity. When it comes to managing a recall, manually navigating through the process can be inefficient and prone to error. To alleviate this, there are several capabilities inherent in the Compliance Management System that help manage the process. 

Here are some ways the Compliance Management System aligns with the best practices of managing a recall…

  1. Submit Recall Information: Going through the process of a recall requires many steps, and automating these steps is helpful in managing all necessary actions. The first step is to submit all product complaint and defect data to the FDA, along with information describing how you intend to return all products. An automated complaint handling process simplifies this process, by keeping track of all complaints that you received. It will also help you manage the investigation and resolution of these complaints in compliance with the FDA’s guidelines.
  2. Notify the public: The next step is to notify the public. The Compliance Management System’s Document Control module makes this easier. It’s necessary to have the required documentation, which can include templates for notifications letters, press releases and work instructions. Revision control is a function of the Document Control system that ensures that all documents are maintained, up to date and controlled. This saves time when under the pressure of a recall and allows Life Science industries to keep the process consistent and organized.
  3. Evaluate the Recall: The next step of the recall is the evaluation phase. After the public has been notified and the recall process initiated, a recall evaluation is a critical step in measuring the effectiveness of the recall—quite simply put, “did it work?” During this phase, status reports must be created, consisting of the date that each customer was notified, the number of customers who were notified, how many responded, how much product was returned and details of the effectiveness check. The Corrective Action system is beneficial in this stage as it allows you to determine the root cause of the recall, record and track corrective actions that were taken and ensure that the corrective action was effective. The system's Centralized Reporting capability then provides a thorough report for the FDA to review at each phase. The Reporting system helps to foster continuous improvement in identifying trends to preventing similar occurrences in the future.

In the event of a recall, your organization must act immediately. Automating this process with the Compliance Management System ensures that nothing is overlooked and that all processes are conducted properly and timely, while drastically decreasing the chance of human error.

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