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Regulatory compliance of CTL Software

Regulated industries are required to use validated electronic records and signature systems equivalent to paper records and handwritten signatures to assure data quality and integrity. This mandate is defined in U.S. Food and Drug Administration (FDA) 21 CFR Part 11 and its European counterpart, EU Annex 11 regulations.

CTL’s software is developed in house following these requirements (learn more).

CTL’s Software products specifically address all components of Part 11.10 mandates (the links elaborate on how our software addresses each requirement):

CTL offers IQ, OQ and PQ for its regulated customers. Our ImmunoCompliance™ Package includes a three-tier offering.