21 CFR Part 11 Traceability

The 21 CFR Part 11 Electronic Record and Electronic Signatures is an FDA standard consisting of requirements for computer systems with regard to Electronic Records and Electronic Signatures in pharmaceutical and other regulated industries. The goal is to ensure integrity of traceability data throughout drugs life cycle, from research to occasional recalls to development, records, production, and distribution.

IASTECH is fully capable of implementing or making changes to computer systems (automation and IT) so that they are in compliance with the standard.