Security

LabChip GX System - Supporting Regulatory Compliance

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Executive Summary

In the regulated environments, users are required to qualify analytical instruments for their intended use, to maintain the instruments on a regular basis to ensure the performance, and to keep the maintenance records. If the instruments are computerized, the users are subject to 21 CFR Part 11 requirements, which include validation of systems, audit trails, copies of records, record retention, and other provisions. Caliper is fully aware of customer requirements in terms of DQ, IQ, OQ, PQ, and 21 CFR Part 11 compliance. This white paper describes how services and products are able to address needs using systems in regulated environments.

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