Quality Systems

Ed Halpin is vice president of business development at VelQuest Corporation. EdH@velquest.com

Gordon Johnston is president of VelQuest?s European operations, The Heath Business and Technical Park, Runcorn WA7 4QF, UK. Tel. +44 1928 513 813 Fax +44 1928 513 822 Gordon.Johnston@velquest.com

Articles

 In an interview earlier this year (Bio-IT World, April 2003), Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), stated that "The original intent of the rule (21 CFR Part 11) was to facilitate the introduction of electronic technology to the process of the US Food and Drug Administration (FDA) submissions, as well as manufacturing and production. Part 11 was created to provide common-sense guidelines on how to do in the electronic world what was previously done on paper. During the last 5 years, however, confusion regarding what is included in the regulation and how to enforce it was impeding the introduction of new technology. The rule had created exactly the opposite of what was intended." 

Automated Compliance: Reducing Costs and Maintaining Quality

Robert G. Kieffer, PhD, is president of RGK Consulting.

A procedures system must be well designed and managed to be effective and efficient.

Procedures: Improving Their Quality

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

Preventing the Practice of Testing Into Compliance

Irwin Silverstein, PhD, is vice-president and chief operating officer at International Pharmaceutical Excipients Auditing, 1655 N. Fort Myer Drive, Suite 700, Arlington, VA 22209, tel. 703.351.5266.

A new set of proposed GMP standards for excipents may present more problems than benefits.

Quality Assurance/Quality Control