21 CFR Part 11 Compliance Module (4Y, 5Y, CY10)
The 21 CFR Part 11 Compliance Module is a solution especially useful for those users who are obliged to conform to provisions of 21 CFR Part 11 and EU GMP Part 4, Annex 11 regulations. These two documents determine the rules for using electronic records and signatures.
Data protection is guaranteed by:
- advanced password settings,
- control of logging correctness, various permission levels,
- data management access,
- backup,
- electronic signature,
- time-defined automatic logout,
- modification record to Audit Trail file.
The module includes "Audit Trail".
Audit Trail 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, html.
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Buying from the producer is all about the pros
✓ Update as standard
You always get the latest version of the device and software. We are constantly improving our products.
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Technical support from the product developers. Who better to know the answers to your questions? Like our Facebook – profile – stay in touch with us.
✓ Smaller carbon footprint
A solidly packaged shipment travels only one way – the one to you.
✓ Long life for your balance
In our permanent offer you will find accessories for our balances and scales, such as cables, weighing pans and power supplies, as well as all spare parts. And we carry out legalization and periodic inspections in our laboratory.
✓ The important thing
You buy a product developed and manufactured in Europe – you get a device with a certain standard of compliance.
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