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Compliance of RADWAG weighing instruments with 21 CFR part 11

RADWAG balances are compliant with regulation 21 CFR Part 11 and with EU GMP Volume 4, Annex 11. Our devices feature numerous functions designed to secure and monitor operation of particular users. 

Effective data protection is guaranteed by:
  • advanced password settings,
  • control of logging operation correctness,
  • granting users with individual permissions levels,
  • automatically carried out logout operation,
  • e-sign, e.g. of series of measurements,
  • restricted access to data management,
  • data backup,
  • record of Audit Trail file modification.
Due to record of Audit Trail file modification, it is possible to trace back user activity.

Validation performed by our company consists of installation, operational and process qualifications.

Software accordant with 21 CFR regulation is available on 4Y series balances. 

RADWAG Elektronische Waagen

Torunska 5
26-600 Radom
Tel.: +48 48 386 60 00
VAT Nr.: 796-000-03-27
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