Pharmacovigilance monitoring of mobile app reviews

The Cross4Channel® App Review Guard fully enables audit-compliant monitoring for mobile application ratings and reviews within various app stores.

For this purpose, the software has an integrated audit trail which acts as an internal control system. To ensure complete documentation, all executed procedures are monitored, documented and logged within this audit trail.

Detailed information

As a pharmaceutical company or manufacturer of medical devices, you have a national and international obligation to use appropriate measures and processes to monitor the safety of medicines (pharmacovigilance) and medical devices.

This obligation also applies with mobile applications. If your company publishes an application within an app store, the reviews of this application also open a communication channel which can be accessed publicly.

Cross4Channel® App Review Guard offers a technical solution that can be used to fully monitor a wide range of applications in an audit-compliant manner. 

Our system guarantees high reliability and maximum availability. This service is guaranteed by the simultaneous execution of multiple instances within the system. Due to established standard operating procedures in the system architecture, system development and operations, no damage will arise in the event of a partial failure, as another part of the system will take over the function. This type of system security is also known as redundant architecture and provides the highest level of security and quality.

If you have any questions we are happy to assist you. Feel free to contact us at any time.

App Stores

All of todays well known app stores have third-party application interfaces and can be monitored by the App Review Guard.

 
 
 

Pharmacovigilance regulations

The App Review Guard operates in accordance with the following regulations and legal provisions:

German Pharmaceuticals Act

According to § 63 b AMG (Medicines Act), the Act on the Marketing of Drugs requires the holder of a marketing authorisation to fulfill his general pharmacovigilance obligations. This includes scientific evaluation and documentation with the aim of minimising risk.

Medical Devices Safety Plan Ordinance

The institutions of the European Union have dealt extensively with the topic of pharmacovigilance in recent years and have issued various legal provisions governing the monitoring of reportable events relating to pharmaceuticals.

European Guidelines

During the development of the App Review Guard, attention was paid both to the “Guideline on good pharmacovigilance practices” (GVP), which describes the quality of the case documentation in Module VI, Section VI.B.5, and the European Commission Implementing Regulation (EU) No 520/2012, which deals with documentation and the QMS.

Food and Drug Administration

The App Review Guard also supports you in complying with the reporting requirements of pharmacovigilance notifications under the FDA’s “Code of Federal Regulations (CFR) Title 21” 314.80 (b).

If you have any questions we are happy to assist you. Feel free to contact us at any time.

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