Pharmacovigilance monitoring across social media channels

The Cross4Channel® Social Media Guard fully enables audit-compliant monitoring of a wide variety of social media channels.

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.

The high standards of drug safety (pharmacovigilance) and patient safety have historically made it difficult for pharmaceutical manufacturers to maintain and monitor digital communication channels on social media.

The great effort involved in monitoring Facebook pages, Twitter accounts or the delivery of social media advertising generally makes them highly expensive to monitor.

Cross4Channel® Social Media Guard offers a technical solution that can be used to fully monitor a wide range of social media channels 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.

Channels and Platforms

Almost all social media channels today have third-party application interfaces and can be monitored by the Social Media Guard.

 
 
 
 
 
 
 
 

Pharmacovigilance regulations

The Social Media 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 Social Media 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 Social Media 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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