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About Dr. Teri Stokes

Dr. Stokes brings 20+ years of consulting on CSV projects to help companies large and small develop common sense compliance practices for their electronic data integrity validation, audit, and inspection needs.

Performing mock audits and third party audits of suppliers and services can train new QA staff in industry standard approaches. On the job training and project coaching in formal testing practices also builds end user expertise for creating validation documentation that is able to pass system audits and inspections.

Dr. Stokes also has a special focus on helping software developers document their software development life cycle (SDLC) in a common sense way that works for the GXP regulated market. The target is operational compliance to relevant government good practice regulations for GLP, GCP, GMP, Electronic Records, and Data Integrity (GXP). Developers can plan an agile software project process to produce operational qualification and formal testing documents that support improved product quality, ongoing maintenance, and positive audit experiences.

Experience

Cytel, Inc.: QA Director/Computer System Validation

For 2.5 years, Dr. Stokes worked for Cytel, Inc. based in Central Square, Cambridge, MA and 460 Totten Pond Road, Waltham, MA. Cytel is a world recognized supplier of clinical statistical analysis and data management to GCP standards.

Dr. Stokes established Cytel’s computerized system validation (CSV) function worldwide. She wrote the Company CSV Policy and CSV Standard Operating Procedures. She trained Cytel software engineering professionals in India, IT professionals in Cambridge, MA, and multiple system validation end user teams dispersed across Europe, USA, and India. She also conducted IT audits of data centers and third party software suppliers. She hosted CSV topics for client audits at Cytel. Teri retired from Cytel Sept. 28, 2018.

GXP International: Independent Global CSV Consultant

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.

Digital Equipment Corporation (DEC/Digital)

For 16+ years at DEC, Dr. Stokes kept a focus on the pharmaceutical, biotech, and chemical industries across her various global assignments. Her last assignment was as Director of Computer Validation Services in the Americas. May 1990 to June 1995, Dr. Stokes worked for DEC in Basel, Switzerland and established Digital’s computer validation consulting services business across Europe. During 1993-95, Dr. Stokes served as a Founding Member on the Board of Directors of the European Forum for Good Clinical Practice (EFGCP) in Brussels, Belgium and participated in the Audit Working Group of the EFGCP.

University Education:

Walden University - Institute for Advanced Studies, Minneapolis, MN
PhD in Administration - Regulatory Impact of Computers Used in Clinical Trials.
Dissertation title: Clinical Data Management Trends: New Technologies and EC 1992

Lesley College, Cambridge, MA
MS in Applied Management
Thesis title: Remote Data Entry in Clinical Trials: Technology and Market Readiness

Boston University, Boston, MA
BA in Biology - PreMed Biology and Chemisty

Certificates:

Wellesley College, Wellesley, MA
Institute in Chemistry supported by National Science Foundation

Faulkner Hospital, Boston, MA
Medical Technology

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