A software package compliant with 21 CFR Part 11 is optionally available for the speedwave XPERT. The software package covers user management, password protection, audit trail and documentation as well as export and print functions.
An IQ/OQ package is also available for the speedwave XPERT. This qualification package ensures that the speedwave XPERT meets legal requirements.
The combination of the 21 CFR Part 11 compliant control software and the IQ/OQ package allows consistent traceability and documentation of the use of the speedwave XPERT. This guarantees that the speedwave XPERT fulfils internationally valid pharma regulations, especially those of the FDA and GLP/GMP or GAMP.