21 CFR part 11 in Checkweighers

21 CFR part 11 in Checkweighers

RADWAG Balances and Scales (Poland) - To ensure compliance with 21 CFR part 11 and EU GMP part 4, annex 11 DWM and DWT/RC checkweighers with PUE 5 terminal now feature new functionalities. Range of protections was introduced to ensure logging safety along with function of saving all modifications carried out on the scale to Audit Trail file.

In accordance with the requirements of the regulation, the following functions were implemented:

  • 10 permission levels for operators to be defined by the administrator,
  • requirements for each operator's passwords (determined by the administrator: minimum length, upper-case letters and digits quantity, special signs quantity),
  • the requirement to enter new password at first logging (the first password is entered by the administrator creating the account),
  • determination of password validity period in days
  • automatic logout after a specified time of inactivity
  • operator lockout after 3 incorrect login operations; lockout time specified,
  • unlimited account lockout after 6 incorrect login operations; the account can be unlocked by the administrator,
  • modification record to Audit Trail file.

Audit Trail records all modifications carried out on the scale with the possibility to add information on modification reason. This applies to all operational parameters of the checkweigher, e.g. conveyors speed, enabling/disabling ejector, ejector settings modification, checkweigher start/stop, logging and data contained in all products, operators, weighings and reports databases. All login, start, stop operations and report generating are recorded.

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