SAFETY-EASY

Safety-Easy is a pharmacovigilance database system which complies with European and world-wide regulatory requirements.

Safety-Easy is an externally-hosted solution that works on the SaaS model. It is a web application accessible through FireFox, which is the web's most secure and easy to use browser.

Using an on-line service has numerous advantages:
No need to procure expensive hardware such as servers and client machines.
No need to purchase user licenses for the database or other software.
No mobilization of internal resources such as database administrators or software maintenance personnel.
No need for long and complicated deployment.

What's more:
You have full control over Safety data.
You are sure to be compliant with regulations..
You are ready for any audit.

SAFETY-EASY FEATURES

Safety-Easy enables you to meet all your regulatory requirements:

 Easily enter your pharmacovigilance reports and export them as XML files in E2B format suitable for e-transmission to health authorities.
Import cases in XML E2B format
Publish your regulatory reports: CIOMS, MedWatch, etc.
Publish the appendices to your regulatory reports: PSURs, ASRs, etc.
Handle your daily pharmacovigilance requirements (e.g. determining need to report, QC, etc.)
Incorporate the two annual MedDRA updates.

APPLICATION SPECIFICATIONS

E2B fields

Regulatory agencies world-wide (e.g. FDA, AFSSAPS, MHLW) use the E2B common messaging format.
ICH recommendations for pharmacovigilance stipulate the data elements for transmission of individual case safety reports.

Your data will be entered in specific fields. All E2B fields follow ICH E2B(M) guidelines.

XML files

XML (eXtensible Markup Language) is used as the standard for data transmission. XML is the standard harmonized support for ICSRs (Individual Case Safety Reports).

Your IT system has to be capable of generating ICSRs in XML, in compliance with the above guidelines.

So there is a common unified format for ICSRs: Data is entered in E2B fields and then transmitted in XML format.

Compliant with 21 CFR PART 11

In the event of an audit, you must be able to prove that your pharmacovigilance system - particularly the e-transmission part - is reliable, and that it complies with the regulations. Data must be transmitted securely and proper records must be kept.

MedDRA

Safety-Easy ensures that MedDRA terminology updates are applied.
A practical, efficient coding tool is an integral part of Safety-Easy.

e-transmission

Using Safety-Easy together with an internal Gateway offers the advantage of rationalizing case management.
Safety-Easy is compatible with e-transmission solutions such as EVWEB Trader.