Complaint management software : complaint handling and Regulatory reports

Grievance dealing with and administrative announcing are an unpreventable piece of the Life Sciences industry. Our SmartSolve® Complaint Management programming makes these procedures less demanding to deal with in a convenient and agreeable way. With SmartSolve Complaint Management you can:

Show administrative consistence.

Give Complaint Management software a chance to remove the mystery from your examinations. Our configurable admission choice trees help you reliably separate grumblings from other client connections. You can likewise catch key item data like market endorsement date, item characterization, one of a kind gadget identifier (UDI), and permit numbers. At that point utilize our implicit reports and protest history to demonstrate that particular items and disappointments were examined reliably without fail. This proves to be useful while submitting electronic Medical Device Reports (eMDRs) for antagonistic occasions, and when your grumbling taking care of framework is reviewed amid a FDA investigation.

Streamline grievance admission for brisk reaction.

Once you're mindful of a grumbling, the clock begins ticking. Protestation Management's adaptable admission choices give the quickest way from occurrence attention to activity. Episodes are immediately recorded utilizing our straightforward, configurable admission shapes. In addition, our Quality Intake Portal empowers individuals from your expanded request chain – including field faculty and human services experts - to rapidly and safely record occurrences.

Admission information consequently drives your examination and determination work process. High-seriousness issues and unfavorable occasions are in a split second raised to the correct staff for examination.

Disentangle worldwide antagonistic occasion detailing.

Field Service Management encourages you comprehend your announcing prerequisites all through the worldwide commercial center. Our protestation administration framework streamlines your entries with standard detailing for the FDA, EU, Health Canada, Japan, and Australia. It is safe to say that you are venturing into extra nations? You can without much of a stretch design choice trees or include administrative reports for any nation on the planet.

For medicinal gadget makes and shippers submitting eMDRs in the United States, Complaint Management consequently makes, approves, and arranges the XML petition for accommodation to the FDA. To additionally streamline consistence, while actualizing in the Pilgrim Cloud, Complaint Management naturally presents the eMDR record and gets and connects the fitting affirmation documents (ACKs) from the FDA.

Increment administration oversight.

Do you know what number of protestations you get for every one of your items? With our configurable revealing and quality insight instruments, you can without much of a stretch screen and investigate your protest information, including due dates, basic errands, repeating disappointment modes, and the sky is the limit from there. You'll have the capacity to determine issues rapidly and settle on successful choices in view of noteworthy knowledge from your reports.

Tailor, broaden, and incorporate your quality procedures.

Grievance Management is created on Smart Solve's Platform for Compliance. Smart Solve's Configuration Tools, Platform Services, and Enterprise Integration abilities make it simple to tailor, broaden, and coordinate procedures as the requests on your quality administration framework develop. Besides, Pilgrim's protected, cloud-based organization alternatives and computerized approval devices enable your group to get up and running on new procedures rapidly.