Complaint Handling and Adverse Event Reporting
Software
|
|
Web application
Access it from anywhere with a PC and a browser
Comes with flexible hosting options - on our servers or
yours.
|
Contact us at info@makromed.com
or 603-890-3311 x300 to conduct a convenient interactive evaluation now,
using your existing PC with no demo programs or anything else to
download.
InfoMed Complaint Handling and
Adverse Event Reporting Software is designed to
help you manage a sound customer complaints handling and adverse events
reporting program. It allows you to organize, track and trend such
complaints. It allows you to assess for corrective actions to mitigate
these complaints. It has built-in modules to generate regulatory
reporting for FDA, EU’s Competent Authorities and other regulatory
agencies around the world. Built in reports, trends, and much more...
General
Regulatory
Compliance
- Comply with FDA’s GMP (QSR) and MDR regulations
- Comply with European Union’s Medical Device
Directives (MDD)
- Use Decision Trees and Reporting Modules for USA,
EU, Canada, Japan, and Australia
- Meet the requirements of international quality
standards such as ISO 13485
- Full eMDR Module for AS2 submissions.
Customer
Satisfaction
- Organize and track customer complaints
- Make corrective action assessment
- Customer feedback through letters and reports
Product
Improvement
- Trend complaints and underlying causes
- Generate management reports
Click here
to download a brochure on InfoMed 9i Complaint
Handling and Adverse Event Reporting Software.
|
