Comprehensive Support Streamlines Recall Notification, Reply Capture for Medical Device Producer | Life Sciences
Partnering with RRD's healthcare experts provides efficient and compliant recall notice fulfillment
A leading global producer of medical devices and therapies faced inefficiencies in fulfilling highly-regulated, time-sensitive recall mailing notices. In the event of a recall, the FDA requires the company to print and mail personalized recall notifications. They are also required to obtain confirmation from the consumer that they received the notice. The company must then report both the mailing and the reply capture back to the FDA.
Due to company growth and an increase in recalls across the life sciences sector, the company’s existing recall notice vendor was not able to scale to the capacity that was required. The vendor also lacked SOC 2 + HITRUST compliance, which posed a risk to the company's regulatory compliance.
To manage reply capture, the company staffed an internal print shop that manually collated responses and labels at office desks. However, the onset of COVID-19 transitioned the personnel into remote workers, leaving no one to fulfill this task.
Ultimately, the company sought an end-to-end provider who could deliver complete recall notice fulfillment and reply capture support. They aimed to ensure full compliance with regulatory requirements — and full protection of their end users’ safety.
The company partnered with RRD Life Sciences, who stepped in as a one-stop provider to take over their recall notice and reply capture workflow. With SOC 2 + HITRUST facilities, RRD was able to provide full assurance of compliance and adherence to strict FDA regulations.
Above and beyond printing, RRD’s mail merge services are able to take individual data files and auto-populate all variables within each letter, including the required name and address. Additionally, RRD provides specific, enhanced delivery tracking. For reply capture, RRD receives the reply cards, scans them, and then compiles the information to produce a full report that is sent to the FDA.
Given that mailings are time-sensitive and turnaround times and methods are regulated, compliance is a key priority. RRD uses advanced automated technology to efficiently manage the mail merge process, including matching expedited UPS labels to the correct envelope.
RRD also deployed RRDCare, a proprietary portal solution designed for healthcare clients. RRDCare is a secure platform that manages all recall mailings, resulting in a streamlined workflow that eliminates the need for cumbersome email threads and increases visibility throughout a recall event. This enables the client to easily manage their current job status and ensures compliance with all necessary regulations.
Additionally, in the event of an audit from the FDA, RRDCare simplifies the process by providing a centralized, secure location for all relevant production and tracking data related to the recall.
In addition to streamlined processes as well as increased efficiency and compliance, RRD’s solutions enabled the company to streamline its recall notice and reply capture workflow. Benefits included:
- Increased mail tracking down to the letter/package
- 185% increase in packages fulfilled per day due to increased automation
- Formal planning and preparation for potential FDA audit
- Increased adherence to FDA regulations
- Redirected focus back to core business functions due to outsourced reply capture