Does ValProbe meet 21 CFR part 11 and if yes, how is this done?
ValProbe was designed as a fully validated closed system with two levels of security access. The ValProbe system generates accurate and complete records in both, human readable and electronic formats which cannot be changed or modified (modification attempts render files unusable). The unique user name / ID combination comprises the electronic signature required for traceability and audit purposes. The ValProbe software maintains an audit trail that provides a complete listing of each event that affects the integrity of the ValProbe PC program, Loggers, and calibration, verification and qualification study files. The audit trail lists events for the current month by date/time, event, who performed the event, and that individual’s permission level.
