Flowspek AG, Hegenheimerstrasse 4, 4055 Basel
Tel.: 061 695 9696, Fax.: 061 695 9697
UVSX 21CFR Part 11 Compliant Software for UVIKON XS / XL
The UVSX 21CFR Part 11 compliant software is available as an option for the UVIKON XS and XL spectrophotometers.
The software supports all common UV/VIS methods including both multiple activity calculations within a run and multi-wavelength kinetic capabilities using an automatic cell changer.
The possibility to include control of external autosamplers for fully automated analysis of large batches of samples is also available and can be configured to suit the type of sampler and customer requirements.
High Security Level
Only Administrators have access to the security settings for Options, Backup and Login. The software automatically checks for serial number and instrument type at every start-up. Group definitions allow data to be filtered for display according to the logged-on users.
Fully compliant with 21CFR Part 11 Rules
Access rights and user permissions are defined by the administrator in a controlled security area. Methods and acquisition reports are maintained under strict revision control. Configurable audit trail for complete history tracing including a deleted report trail.
A statement covering all aspects of the compliance with the requirements of 21CFR Part 11 is available by following the documentation link above.
Reports can be formally signed with an electronic signature provided appropriate rights have been assigned. Once signed the report is frozen and cannot be modified as required under 21CFR Part 11 rules. All signed reports carry appropriate labels on any printed documents for easy identification.
A Lite version of the software is also available for users who do not require compliance with 21CFR Part 11. This software has the same basic functions as the UVSX software but without the extra user administration and audit trails.
Uvikon 900 Upgrades
A special upgrade package is also available for the Uvikon 900 spectrophotometer in order to allow the UVSX software to be used. This upgrade covers both hardware - new processor board and hard disc - and the UVSX software.