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Adverse Event Management

Smarteeva Adverse Management Solution provides for best in class functionality related to Adverse Event creation, lifecycle and submission to regulatory authorities. Utilizing our award winning smart audit trail and meaningful data change features, knowing when to file follow up reports is a breeze. Also, all FDA and EUMDR required codes come pre-populated and ready to use. Approve on the go with single-sign on e-signatures.

Decision Trees

Sophisticated decision trees will allow for an educated and process driven determination of whether a reportable event occurred. Decision trees will also allow for the determination of the type of reportable event and the due date

DEMO

Pre-populate data

Pre-populate common data such as manufacturer information, and even pick from pre-set and common language. Spend time on crafting the right response to the agencies rather than data entry

DEMO

New data management

Knowing when to submit a supplemental or follow-up report is extremely important to meet the deadlines of Adverse Event Management. Our Smart Audit Trail makes this process a lost easier

DEMO

Integrated with Complaints Management

Adverse Event Management and Reporting can be integrated with the Complaint system so that most of the information can be reviewed in the same place and prepopulated

Meaningful Data Change

See all the meaningful data that has been changed about all the related Adverse Event Records. For example, see what important information changed in an investigation or complaint directly from the Complaint screen

 

 

 

Create XML and PDF Reports

Create XML and PDF reports for EUMDR, MDR, Canada and other countries that require regulatory reports. Ability to create additional reports as needed

Regulatory Codes

All MDR (Patient, Device, Component, Method, Eval) Codes and EUMDR Codes are included in the system and they can be updated every time the agencies send changes or additions

Manage Reusable Data

Information such as Manufacturer Information, Reporter Information or Importer Information can be preset and managed separately. Spend less time entering data and more time crafting the message to the regulators

Sophisticated Decision Trees

Manage decisions about report type, due date and other information based on sophisticated decision trees which make data entry easier and more process based

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