2011 Journal Article

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New Journal Article: July 2011

Teri Stokes, Ph.D., EU GMP Guide Annex 11: Management’s view on controlling computer systems, gmp review: analyzing international pharmaceutical regulations, vol. 10, no. 2, July 2011, pp 14-16.

2007 Journal Article:

Every regulated organization, however small, needs a strong quality management system. Dr Teri Stokes examines the role of senior management in setting up and maintaining such systems, and offers pointers from US FDA guidance.

• Stokes, Teri, Ph.D., A Quality Role for Senior Management. GCPj, Informa UK, Ltd., Oct. 2007 pp. 11-15.

Invited Book Chapter:

This book chapter discusses the quality of electronic data and computerized systems from a senior management perspective.

Prince, Richard, Editor. Pharmaceutical Quality published by DHI Books and PDA Press, June 2004.

• Stokes, Teri, Ph.D. Chapter 13: Quality for Computerized Systems and Electronic Data in Regulated Environments pp 463-479.

2006 Journal Articles :

This article discusses computer validation from the view of startup companies and the perspective of senior management.

• Stokes, Teri, Ph.D., Company Strategies & Tactics: The Business Priority for Electronic Data and Systems Quality in Startup Companies. BioIT: A Bioexecutive’s Guide to Information Technology, Nov. 2006 pp. 10-12.

This article addresses the subject of computer validation training for clinical research associates, clinical monitors, and protocol teams.

• Stokes, Teri, Ph.D., Professional Development: When GCP Meets IT. Computer validation training for non-computer professionals. GCPj (GCP Journal) April 2006 pp 15-18.
  

Electronic Patient Diary (EPRO) Series:

This series of articles was written to share experience-based validation practices for electronic diaries. The principles apply to interactive voice response (IVR) systems as well as hand-held devices.

Stokes, T., Ph.D. & Paty, J., Ph.D., Technology Update 2002/2003 Series: Electronic Diaries,

• Part 1: What is a Subject Diary and How Do Regulations Apply? Applied Clinical Trials. Advanstar Communications, September 2002, pp 38-43.
• Part 2: The Role of the Clinical Protocol in Developing and Implementing Electronic Diaries , March 2003 pp46-56.
• Part 3: Developing and Validating Electronic Diaries: Roles for the Technical and Clinical Teams , June 2003 pp. 68-78.

Classic CSV Series - IQ, OQ, PQ and QA/QC:

This series of articles provides a concise course in the basics of computerized system validation (CSV) from the role of the end user (Part 1), the IT/IS department (Part 2), the software supplier (Part 3), and QA quality management system view (Part 4). These validation concepts remain accurate for today and apply to systems regulated by GLP and GMP as well as to systems under GCP.

Stokes, T. Ph.D., Technology Update 2000/2001 Series: Validating Computer Systems,

• Part 1: A GCP Computer System is a Lifetime Responsibility . Applied Clinical Trials. Advanstar Communications, August 2000, pp 38-43.
• Part 2: GCP Validation of Platform and Infrastructure Systems , Sept. 2000 pp55-66.
• Part 3: GCP Software Verification , Nov. 2000 pp. 48-58.
• Part 4: The QA Role in Computer Validation , Feb. 2001 pp. 64-72.

Laboratory Systems Validation:

This article discusses computer validation from a good laboratory practice (GLP) view.

• Stokes, T., Ph.D., Computer Validation in the Regulated Laboratory . Analytical Validation in the Pharmaceutical Industry 1999. A Supplement to Pharmaceutical Technology. Advanstar Communications, Vol.23, No.2, Feb. 1999, pp 30-34.

Investigator Systems Validation Series:

This series of articles was written to help clinical trial sites address compliance with computerized systems. It discusses how to buy software (Part 1) and how to install it for regulated environments (Part 2). How to validate and manage computer systems ongoing is addressed in Part 3. Managing systems in a compliant way (Part 4), how to validate legacy systems (Part 5), and how to approach sponsor audits and regulatory inspections (Part 6) complete the series.

Stokes, T., Ph.D., Technology Update: Computer Systems Validation

• Part 1: Software Purchase and GCP Compliance . Applied Clinical Trials. Advanstar Communications, Vol.5, No.9, Sept. 1996, pp 71-75.
• Part 2: Installing GCP Systems at Investigator Sites , Jan. 1997, pp. 46-50.
• Part 3: Validation of GCP systems at Investigator Sites , Feb. 1997, pp. 46-50.
• Part 4: Operating GCP Systems at Investigator Sites , April 1997.
• Part 5: Retrospective Evaluation - A Structured Approach, June, 1997.
• Part 6: Audits and Inspections - A Survive and Thrive Approach, Aug., 1997.