TitriSoft 2.6 P

In this case, the “P” does not mean “professional”, but rather “pharmaceutical”.

Additionally to the standard version TitriSoft 2.6, the TitriSoft 2.6 P fully meets all requirements of the FDA 21 CFR Part 11 regulation regarding ”Electronic Records“, ”Electronic Signature“ and ”Audit Trail”.

The FDA (i. e. Food and Drug Administration of the USA) 21 CFR Part 11 regulations describe how to deal with electronically stored data (”Electronic Records“) and how to prepare electronic signatures (”Electronic Signature“). These regulations are binding for all companies offering medical, pharmaceutical or food products and services in the USA.

in comparison to TitriSoft 2.6

• Electronic Record
• Electronic Signature
• Audit Trail
• Controlled Access
• Copies of Records
• Manual with forms for SOP´s, IQ, OQ, PQ and validation reports