The MultiCheck, EasyCheck, TBH 325 and TBH 425 tablet hardness testers can be controlled externally via the validated MC.Net software. This configuration significantly increases memory capability for storage of numerous products.
The MC.net software itself allows CFR 21/11 compliant operation (user entry, user levels, product data, storage of results, CFR Audit Trail) as well as advanced statistical features, batch comparison, trend analysis, etc.
MC.Net stores the product data results as well as CFR 21/11 compliant Audit Trail. Due to the high memory capacity of a PC the capacity of stored users, product data, results as well as CFR 21/11 Audit Trail is nearly unlimited. Tolerances for all tablet hardness testers results can be individually set or automatically set according to USP or Pharm.Eur. An optional alarm-function stops the unit and creates an alarm in case a sample fails the pass tolerance.
Compliance for tablet hardness testers
The CFR 21/11 compliant user management allows individual definition of user groups, individual user rights for each group including additional rights for individual users etc. Due to CFR 21/11 users can not be deleted from the memory but, the MC.Net software allows to switch users inactive and, on request, only to display active users. Similar to user control, the MC.net software also allows to switch product data inactive and, on request, only to display active product data.
The MC.Net software can create various statistical reports from the tablet hardness tester results, such as test-run statistics, graphical batch statistics, trend analysis etc. The integrated CFR 21/11 compliant audit trail tool of the MC.Net software automatically stores all Audit Trail data of the connected tablet hardness tester .The Audit Trail data may be sorted according to date or user/user group, displayed and printed for hard-copy documentation.