Services | Validation

Alfa Wassermann provides a full validation package for each new Ultracentrifuge which covers: Manufacturing, Software Development, Factory Testing, Installation, Site Acceptance Testing, Installation Qualification, Operational Qualification and Performance Qualification (IQ, OQ, PQ).

Validation

The software is fully validated and tested to meet 21 CFR Part 11 compliance and to meet the requirements of GAMP.

Product contact materials are provided with conformance certificates and with traceable material certificates with each new Ultracentrifuge and through the lifetime of the Ultracentrifuge for parts and consumables ordered.

Calibration

Alfa Wassermann provides a customized service for in field instrument and gauge calibration.  A full calibration scheme can be performed or a number of the instruments and gauges requiring calibration can be selected.  Full certification of testing of each instrument and gauge are provided.