GXP

For 20 years, Dr. Stokes operated her independent CSV consulting firm GXP International. Her clients ranged from global drug companies, e.g., Bayer Corporation to small Contract Service Organizations (CROs) and software suppliers. Successful engagements were delivered for training and coaching software development teams, IT teams, and GXP system end user validation teams. Compliance and Gap audits of internal and external IT and software suppliers were performed. Teri successfully delivered CSV audits, GXP team coaching, and CSV training engagements for clients in North America, Europe, Japan, India, China, and Africa... This is a Computer System Validation methods and practices resource, to help people dealing with for FDA Part 11 and EMA Annex 11 compliance.

Also known as: GXP International

Primary location: Concord United States