Computer System Validation : 21 CFR Part 11

David Nettleton is a 21 CFR Part 11, Annex 11, HIPAA, software validation, and Computer System Validation consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.
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David Nettleton
http://www.computersystemvalidation.com/

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.
-Has completed more than 170 computer system validation projects for mission critical applications.
-Electronic signatures, biometric signatures,

Cost-Reduction without increasing regulatory or business risk:
The 10-step risk-based approach uses fill-in-the-blank templates to capture the essential validation documentation related to requirements, specifications, installation, risk assessment, testing, SOP, training, and system release.
-Increase corporate productivity, and individual workforce member productivity.
-Efficiently create validation documentation.
-Determine risk in a process.
-Write test cases that trace to elements of risk management.
-Significantly lower costs and reduce software implementation time.