GXP International is the home of experience-based, common sense computer validation services and training products provided by Dr. Teri Stokes.
We work with clients in Europe, North America and Asia :
Pharmaceutical, Biotech, and Contract Research firms
Computerized systems and healthcare service providers
Software application providers to the Healthcare Industry
We understand the computer validation impact of global regulations for:
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP & Annex 11)
Electronic Records/e-Signatures (21 CFR Part 11)
We provide practical, realistic, and cost effective ways to assure the return on investment for the cost of your strategic GxP systems and to document that your GxP systems meet the global regulatory requirements for:
Electronic Data Integrity
Auditable Quality Evidence
With more than 20 years of computer validation project experience with satisfied clients, large and small, in Europe, North America, and Asia, we look forward to working with you.