Drug Information Association Logo
Corporate Tagline
Advertisement

GXP International

Description: 

BOOK by Dr. Stokes -August 2011: ISBN 1-933722-53-3 Computer Validation – Common Sense Guide

Book available at www.Amazon.com  PDF Chapters available at www.BioPharm-Guides.com

Founded in 1996, GXP International helps clients implement common sense computer validation projects and prepare their organization for audits and inspections of systems to GCP, GLP, GMP, 21 CFR Part 11, EU GMP Annex 11 (GXP) 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:

OQ/IQ/PQ Validation Start-up Services: For client and supplier organizations (CROs, Medical Device, Pharmaceutical, and Biotech firms)

  • Strategic support for organizations new to US FDA and EU EMA regulated environments
  • Baseline audit of systems and quality practices with executable corrective and preventive action (CAPA) plan
  • Training and coaching program to mentor client through CAPA deliverables

SDLC OQ Support Services: For internal and external developers of software for GXP systems and services

  • Strategic support for designing a practical, documented software development life cycle (SDLC) that can pass Part 11 audits and inspections
  • Baseline audit of SDLC and services to assess GXP compliance level with executable CAPA plan
  • Training and coaching program to mentor client through CAPA deliverables

CAPA Get Well Programs: For those whose computerized systems have failed a client audit or regulatory inspection

  • Hands-on support for addressing CAPA deliverables, e.g., writing policies, SOPs, WIs, plans, reports, etc.
  • Training and coaching of system validation teams and hands-on assistance with OQ/IQ/PQ document packages to industry standards

New and Refresh GXP/Part 11/Annex 11 Training Courses: Delivered with GXP International Certificate

  • Onsite or remote training provided for OQ/IQ/PQ validation documentation and Formal testing Practices
  • Auditor training for how to assess compliance of computer validation projects, third party data centers, and software developers (internal or external)
  • Training and strategy support for electronic archive teams to GXP long term retention needs

Contract “Due Diligence” Part 11/Annex 11 Audits: Performed for Sponsors Using GXP Systems and Data Services

  • Audit of internal systems and data services for GXP, Part 11 and Annex 11 compliance
  • Audit of external/third party systems and data services for GXP, Part 11, and Annex 11 compliance

 

Visit our web site: www.GXPInternational.com; Our Book 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, Ph.D., Director/International Consultant