Information Technology | Information Security

The Information technology (IT) and Information Security (InfoSec) are the necessary parts for successfully functioning of the Pharmacovigilance (PV) System.

Information technology (IT)

IT is a set of related fields that encompass computer systems, software, programming languages and data and information processing and storage.

PharmExpert LLC’ IT system organized appropriately, documentation and record management system are in place, all data stores in Cloud storage and Virtual Private Server.

Computerized system validation (CSV) is ensured. Specified requirements of a computerized system are fulfilled consistently from design until decommissioning of the system and/or transition to a new system. The approach to validation focuses on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.

Information Security (InfoSec)

InfoSec at company built on CIA principle: Confidentiality, Integrity, Availability.  

Information in the PharmExpert is not disclosed to unauthorized individuals, entities and process.

Company maintains accuracy and completeness of data. This means data cannot be edited in an unauthorized way.

Information in PharmExpert available when needed.