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Last update:2012.04.04.
 Regulatory Basis  Forum Issues  Intelligence Services  Web Applications  21 CFR Part 11 Compliant Products 

Web Applications
Web-expert System
Global Quality System
Competency Management

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Web Applications

Web Applications, Globalization, and Global Quality Improvement

How can society benefit from the Web? According to Taguchi, the quality of a product or service can be measured by the cost society has to pay for it. Consequently in an economy where quality of products & services are poor and there is no motivation to improve them then the cost of maintaining the system will continuously grow to the point of disaster. This phenomenon contributed to the collapse of the socialist-communist system.

Contrary to many, we claim that globalization is good for quality improvement, therefore it plays an important role in the improvement in the quality of our lives. We also claim that Web can be a critical quality asset in the globalization of quality. Let us see how?

Web can be considered as a unique operating system which transcends physical and logical barriers. If we are bold enough we can call it a Transcendental Operating System (TOS). How can we leverage TOS for the improvement of quality? To start with, we propose three application models:

Global Leveraging of Expert Human Resources here we propose a Human Aided Web-Expert System ("HAWES", pronounced as "How is") with decision support capability. Our model consists of the following modules:

  • SQL database for the storing of events
  • Logical structure with convergent sequence of events
  • Knowledge base which supports the process
  • Human expert catalyst to move the process in the right direction and with efficiency, and
  • Final Report.

Our first HAWES product is CIPER (Computer Integrated Part Eleven Resolution).

Proficiency Testing for Global Quality System (PTGQS) here we propose a new model for proficiency testing. In some respect it is a Web-LIMS but modified to standardization of proficiency and detailed evaluation of cause and effect relationships relative to the deviations. PTGQS is an important complement to competency training. In principle, it also models the commitment of ICH to standardize testing for the improvement of quality and for the reduction of costs in the pharmaceutical industry.

Our first PTGQS product is LALPT, which stand for LAL-Proficiency Testing.

Competency Training & Exams (CTE) e-learning & e-exams have been available on the Web for some time. Our model differs in the following ways:
CTE can be integrated to HAWES, and
CTE can be integrated to PTGQS.

A list of CTE products can be found at Competency Training & Examinations.

21 CFR Part 11 Issues
Various aspects of electronic records and electronic signatures
Forum Database
Almost 100,000 searchable messages from 16 working newsgroups. Updated regularly.
Warning Letters Knowledge Base
An extremely versatile database that will assist familiarization with the regulatory requirements
Competency Trainings & Exams
Multimedia enriched learning materials, exercises and exams.
On-line Trainings & Exams
Web-based learning materials, exercises and exams

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