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GXP International

Description: 

NEW BOOK by Dr. Stokes -August 2011: ISBN 1-933722-54-1

Computer Validation – Common Sense Guide available at www.BioPharm-Guides.com

 

Founded in 1996, 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.

 

Each engagement is customized to client needs and usually includes a combination of the services listed below:

 

Management Control Services

  • Develop Company Policy for Computerized System Validation and for Electronic Data Quality; SOPs for Validation Package Management (IQ/OQ/PQ), Formal Testing Practices, and Business Review; Master Validation Plan for a Computerized System or Electronic Data Capture Project; 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 Supplier Groups and Work Process Life Cycle for End Users in GXP Regulated Areas
  • Develop and Deliver Certificate Training Programs on Global Regulations, System Concepts, and Validation Practices

 

System Reliability Services

  • Develop Validation Plans for IQ/OQ/PQ of a Specific GCP/GLP/GMP Computerized System; Master Test Plan Process for IQ/OQ of Software Projects and System Test Plans for IQ/PQ in User Acceptance Validation
  • Develop Test Case Descriptions, Test Scripts, Trace-ability Matrices to URS and FRS; Test Summary Reports and Validation Summary Reports 
  • Develop SOPs for Data Center Management; 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 Labs
  • 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; Vendor Audits for GXP Compliance on Behalf of Clients; 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

 

Visit our web site: www.GXPInternational.com; Our Blog: http://blog.gxpinternational.com/; Dr. Stokes’ Linked In Profile:  http://www.linkedin.com/in/teristokes

 

GXP International

Common Sense Computer Validation

 

 

Services: 

Computer System Validation, Consulting, Contract Auditing, GCP Compliance, GLP Compliance, GMP Compliance, Quality Assurance/Control, Standard Operating Procedures, Training

Contact Information: 

GXP International
131 Sudbury Road
Concord, MA, 01742, USA
Phone : 7813543537
Fax : 9783695620
Internet : www.gxpinternational.com
Email : gxpintl@rcn.com
Contact Person : Dr. Teri Stokes