Reliability and Traceability

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.

The Speedwave XPERT can be orderd or upgraded with an additional 21 CFR Part 11 conform software package.
The compliance to 21 CFR Part 11 is ensured by the following components:

• user management
• password protection
• audit trail
• documentation
• export and print functions

Berghof offers an extensive IQ/OQ-package in order to fulfil the strict regulations of the pharma industry. The qualification package enables you to prove that the speedwave XPERT meets legal requirements during ist use.

The IQ/OQ-package consists of the following compinents:

• IQ-documentation
• OQ-documentation
• print templates
• qualification badges

In addition, there is a repeat-OQ for the annual recertification available.