Consulting Services:

We are industry leaders in developing Corporate Policy on computer validation and then translating policy into action at the operations and project level. Training at all levels is part of the interactive process we use on system projects. Team Working Sessions produce real documentation and are customized to client needs for GCP, GLP, GMP, or Part 11 compliance.

Corporate CV Policy	Validation SOPs	System Quality Assurance Plans
Validation and Test Plans	Test Script Workshops	Training Programs
Software Project Support	Gap & Plan Audits	Supplier Audits & Support

Our approach is based on international standards (ISO, IEEE...) and global regulations and guidelines (EU, FDA, ICH, MHW, OECD). All work produces documents drafted to a standard suitable for management review and every consulting day has a defined work output. Let us help you achieve timely, auditable success in your next computer validation project.

Each engagement is customized to client needs and usually includes a combination of the services.

GXP International helps clients prepare their organization for audits and inspections of computerized systems and electronic data practices to GCP, GLP, GMP, and 21 CFR Part 11 standards. From Top 10 pharmaceutical companies to startup biotech firms, CROs, and software/system suppliers, we have helped clients develop and implement a practical and realistic way to meet regulatory requirements within the parameters of defined business goals. This global consultancy is based on the 20+ years of computer validation experience of Dr. Teri Stokes and has resulted in satisfied clients and referral projects in Europe, North America, and Asia.

Management Control Services

	Develop Company Policy for Computerized System Validation and for Electronic Data Quality
	Develop SOPs for Validation Package Management (IQ/OQ/PQ), Formal Testing Practices, and Business Review
	Develop the Master Validation Plan for a Computerized System or Electronic Data Capture Project
	Develop User Requirements Specification for a Regulated Work Process to Be Computerized
	Design Quality Management Systems for Computer Validation and Electronic Data Quality Practices
	Document Software Development Life Cycle (SDLC) in Internal/External Supplier Groups
	Document End User Work Process Life Cycle for Electronic Data Handling in GXP Regulated Areas
	Develop and Deliver Certificate Training Programs on Relevant Regulations, System Concepts, and Validation Practices

System Reliability Services

		Develop Validation Plans for IQ/OQ/PQ of a Specific GCP/GLP/GMP Computerized System
		Develop Master Test Plan Process for IQ/OQ of Software Projects and System Test Plans for IQ/PQ in User Acceptance
		Develop Test Case Descriptions, Test Scripts, Trace-ability Matrices to URS and FRS
		Develop Test Summary Reports and Validation Summary Reports
		Develop SOPs for Data Center Management
		Define Configuration Management Logs and IT/IS Service Level Agreements

Data Integrity Services

		Develop Tools for Non-computer Professionals to Use to Identify GXP Systems in their Work Process and Make an Initial Assessment of System Quality Status, e.g. CRA qualification of site systems capturing primary endpoint data in a GCP trial, QA Audit of Batch Record Systems at a Contract Manufacturer, QC Review of Systems at Contract Laboratories
		Develop an Electronic Data Quality Plan Process and Format for Protocol Teams to Use in Preparing for Roll Out of Electronic Data Capture and Electronic Data Entry in GCP Studies

Auditable Quality Services

		Perform Walk-through Reviews of IQ/OQ/PQ Packages in Progress at a Client Site
		Conduct Baseline Gap Analysis Audits of Computerized Systems and e-Data Practices for GXP Compliance
		Conduct Vendor Audits for GXP Compliance on Behalf of Clients
		Conduct Mock-Inspection Audits to Prepare Clients for Regulatory Inspections
		Develop Audit SOPs for QA Practices During Audits and Inspections
		Review Client SOPs for Validation and Electronic Data Quality Practices