C.S.Q.S. srl is a 21 CFR Part 11, Annex 11, HIPAA, software validation, and Computer System Validation consultant company involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. Complete 21 CFR Part 11 and Annex 11 compliance related to SOPs, training, product features, and software validation. Services include gap analysis, remediation plans, vendor audits, and project management. VMWare in regulated environments.