About CSV
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 240 mission critical laboratory, clinical, and manufacturing software implementation projects.
- 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.
- Electronic signature, biometric signatures, digital pens.
- VMWare in regulated environments.
- Software as a Service (SaaS) compliance.