RADWAG Full Compliance with 21 CFR Part 11 and EU Annex 11
Did you know that compliance with these regulations can be achieved by RADWAG balance itself? There is no need for an additional PC with additional PC software and this sets us apart from our competitors.
What Is 21 CFR Part 11?
21 CFR Part 11 is a set of US Food and Drug Administration (FDA) regulations that address authentication, integrity, security and data storage in the food and pharmaceutical industries. Achieving compliance with these requirements is necessary to avoid regulatory problems and to ensure data quality and reliability in regulated environments. As mentioned, 21 CFR Part 11 applies in the United States; in the European Union countries, these regulations correspond to EU Annex 11.
RADWAG Full Compliance with 21 CFR Part 11 and EU Annex 11
RADWAG balances comply with 21 CFR Part 11 and EU Annex 11. Compliance with these regulations can be achieved by RADWAG balance itself; there is no need for an additional PC with PC software and this sets us apart from our competitors. Our balances themselves are equipped with a 21 CFR Part 11 Compliance Module. This means that RADWAG balances hold an electronic signature and a series of functions that protect and monitor operations of particular users. Full data security is ensured by:
- Electronic records
- Electronic signatures
- Audit Trail
- Validation.
What Is the 21 CFR Part 11 Compliance Module?
It is a solution especially helpful for those users who are obliged to conform to provisions of 21 CFR Part 11 and EU Annex 11 regulations. These two documents determine the rules for using electronic records and signatures.
The module includes Audit Trail, which is a kind of a log where all modifications of balance settings, changes in database records and user activity are recorded. Audit Trail, for example, keeps record of previous and new modifications in databases and informs by whom and when they were introduced. This log allows the administrator to track and find out who logged in, when, who signed a document or who used invalid password.
The Audit Trail Reader freeware allows users, upon connection with a balance, to display Audit Trail log and manage it by generating reports of various formats: pdf, xls, csv or html.
The 21 CFR Part 11 Compliance Module is very simple to activate, which we will do remotely, and you only pay once for lifetime access; unlike our competitors, we do not require you to pay a subscription.
