Titration instruments are the first and, to date, the only titrators that have been certified by a competent and independent body as fulfilling the requirements of the FDA regulation
Metrohm says its Titrando range of titration instruments are the first and, to date, the only titrators that have been certified by a competent and independent body as fulfilling the requirements of FDA Regulation 21 CFR Part 11 to the full extent. Chemgineering of Stuttgart was commissioned to subject the Titrando system to a detailed audit.
The aim of the audit was to check the new Titrando software PC Control 2.0 and Touch Control for Part 11 compliance.
Aspects such as validation, documentation, audit trail, access protection, data encryption and electronic signature were investigated.
The result of the audit: the Titrando software fulfils all the requirements of CFR Part 11, as is proved by the corresponding certificate and a detailed assessment report.
These documents can be downloaded from theTitrando.
Titrando purchasers will, of course, receive them automatically together with the other documentation.
In the titration sector, Metrohm customers now have the choice between two Part-11-compliant software packages: for Titrino systems the Metrodata Tinet 2.5 compliant software is available; for controlling the new Titrando system choose PC Control 2.0.
