14/01/2025
Did you know that RADWAG balances as standalone devices are fully compliant with 21 CFR Part 11 and EU Annex 11? Thanks to the built-in 21 CFR Part 11 Compliance Module. 😮
21 CFR Part 11 and EU Annex 11 are regulations that address data protection in the pharmaceutical and food industry: their authentication, integrity, security and storage. The 21 CFR Part 11 regulation applies in the US whereas EU Annex 11 applies in the EU.
The CFR 21 Part 11 Compliance Module is a functionality that the 5Y and CY10 series balances provide. The module is essential if you need to comply with 21 CFR Part 11 and EU Annex 11 regulations. ⚖️
Data protection is guaranteed by:
✔ Advanced password settings
✔ Control of logging correctness and various permission levels
✔ Data management access
✔ Backup
✔ Electronic signature
✔ Time-defined automatic logout
✔ Modification record to Audit Trail file.
The CFR 21 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 purchase a subscription. What is more, you do not need to use an additional computer with additional software – this also differs us from our competitors. 😉
In summary, the CFR 21 Part 11 Compliance Module is an ergonomic, economic and simple solution:
✔ No additional computer and no additional software
Everything you need is in the balance.
✔ No subscription
Lifetime access and one charge.
✔ No problem
We run it, you use it.
You can also read about the CFR 21 Part 11 Compliance Module here 👉 https://radwag.com/en/21-cfr-part-11-compliance-module-4y-5y-cy10,w1,U1I,110-106-111
And about our balances’ compliance with 21 CFR Part 11 and EU Annex 11 here 👉https://radwag.com/pdf/publikacje_new/en/21_CFR_part-11-5Y.pdf
