Postmarket
Customer complaints are inevitable in any industry, but they take on a greater level of significance in the life sciences. Effectively tracking and resolving complaints is essential for compliance, especially when those complaints have to do with patient safety.
Medical device, pharmaceutical, and blood and biologics companies must report adverse events to the U.S. Food and Drug Administration (FDA). MasterControl Complaints integrates with other solutions to ensure these complaints are monitored and resolved.
Both ISO 9001 and ISO 13485 have complaint handling requirements. Since some countries have adapted ISO standards as their regulations, complying with these standards is even more important.
MasterControl customer complaint tracking software has a secure, time-stamped audit trail in accordance with federal regulations. Anytime someone creates, modifies or deletes electronic records, the event and identity of the user are tracked.
What better way to ensure you comply with FDA regulations than by using the same compliance software they do? For years the FDA's Office of Regulatory Affairs has used the MasterControl Quality Management System (QMS). Recently, the Division of Pharmaceutical Analysis adopted the same solution.
Medical device manufacturers must report adverse events to the FDA. The MasterControl eMDR software solution is ideal for tracking and resolving adverse events. An eMDR form can be initiated from our customer complaint management system, ensuring no data is lost.
The MasterControl Lifecycle Excellence Platform brings connectivity to your business. It ensures all your data is in a centralized location and that no data is lost through human error.
Make sure no data gets lost by using a digitized, completely connected solution.
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