Complaint Handling and Adverse Event Reporting Software

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

• In use since 1990 at hundreds of our customers in the medical device, diagnostic and pharmaceutical industries
• Comes with a certificate of Part 11 compliance and validation and with on-site installation/validation documents
• Long and impressive list of powerful features, many of them exclusive to InfoMed
• In-depth workflow logic

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

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.