Skip to content

Origami Complaint Management

Complaint Management Software – Managing complaints to ensure compliance.
The Life Sciences Industry is one that needs to give utmost importance to compliance. For this efficient handling of complaints and regulatory reports becomes inevitable. The Origami complaint management software helps you to achieve this through:
Our complaint management software rules out the scope for errors in your investigations. Differentiating complaints from regular client interactions, it ensures that they undergo investigation on time and reports are generated accordingly. It also features facilities such as capturing the UDI ( unique device identifier), license numbers, and product classification. You can prove during an FDA investigation that all complaints received were investigated on time and report electronic Medical Device Reports if required.
Ensure regulatory compliance
Ensure quick response to complaints with suitable actions
Delay in processing complaints is considered to be a failure for the organization. With Origami’s complaint management software, you take the fastest path to solving the complaint with necessary actions. The complaint management software comes with intake forms for recording incidents. The Quality Intake Portal allows anyone to securely record incidents that include field personnel up to top-level medical professionals. Once the incident is reported, it automatically drives the software to begin action. The issues are categorized based on the risk factors involved and then assigned to suitable teams for resolving them.
The FDA and health departments of most countries such as Canada, Japan, and Australia have set the standards for adverse event reporting. This complaint management software gives a better understanding of the needs for global adverse event reporting. This becomes helpful if you are planning expansion. The complaint management software automatically creates, formats, and validates files that are to be submitted to the regulatory boards such as the FDA. The eMDR file that is thus generated is attached to the appropriate acknowledgment files from FDA.
Simplify global adverse event reporting
Increase organizational visibility
The complaint data is received in its entirety, monitored and actions are taken to quickly resolve them. The periodical reporting and quality intelligence tools give you a better understanding of recurring failure modes and critical tasks. These reports in turn quicken the action process.
Developed on the Origami Platform for Compliance, our complaint management software is capable of tailoring, extending, and integrating processes with the growing demands of the organization. This is achieved through Origami’s configuration tools, platform services, and enterprise integration services. Also, Origami’s cloud-based deployment options and automated validation tools help to add new processes and get working on them on the go!Complaint management software is integrated into Origami quality management software.
Extend and integrate quality processes
Complaint management software is integrated into Origami quality management software.

Request a Demo