CSV Services Overview

Computer System Validation & Regulatory Services

Program Planning & Development

	Quality System Assessment and Remediation
	Validation Policy and Standards Development
	Systems Assessment, Categorization and Prioritization
	Computer Validation Site Master Plan
	Vendor Qualification / Audit Process Development
	System Life Cycle Documentation
	Validation Maintenance Programs
	Change and Configuration Management
	Validation & Compliance Training

Validation Project Management & Execution

	Project Management Expertise
	Baseline Assessment / GAP Analysis
	Specifications Development
	Validation Planning
	Standard Operating Procedure Development
	Qualification (IQ, OQ, PQ) Protocols and Scripts
	Validation Summary Reports

Auditing

	Compliance Audits
	Third Part Site Audits - Laboratories, CROs, Clinical
	Vendor & Supplier Audits
	Computer System Validation Audits
	SOP & Process Audits

21 CFR Part 11

	Policy Development
	Planning and Remediation

Training

	Validation and Compliance Training
	Basic Computer Validation
	21 CFR Part 11 Training
	Advanced Topics

For further information regarding Computer Validation services and to learn how JAF Consulting, Inc. can assist your organization, contact us at 856-241-1900 or email info@jafconsulting.com

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For More Information Contact: info@jafconsulting.com

Last Revised: January 23, 2006