Friday, 17. November 2017

CFR 21: New IntraVision software version allows for validation!

An important topic in the medical and pharmaceutical industry is data security. To ensure it, the latest version of IntraVision software developed by Intravis includes traceability for users. This function allows users to log actual or attempted actions on the vision inspection system during a defined time period. In addition, this audit trail saves all relevant settings of the system. Should an audit be necessary, an authorized user can easily identify which settings were used by whom and at what time – even months later. These log files are protected against manipulation.

In addition, there is a multi-tier security identification process where each user has a username and password - alternatively, an RFID reader with assigned key access can be used to log in. A password can only be set up if it meets the general criteria for a secure password.

INTRAVIS complies with the applicable standards for a wide range of industrial sectors. These features and standards support our customers in meeting their industry's stringent data requirements as well as the Title 21 (11) Code of Federal Regulations (CFR) of the FDA and the EU GMP Guide (Annex 11). Within the pharmaceutical industry, compliance with these regulations is a prerequisite for successful validation.

The precise assignment of rights allows for traceability of any setting changes

User Account Administration of IntraVision V12