Life Sciences

CAPA Systems Based On The TQM Model And Federal Regulations



Over time, the concept of Quality Control has evolved to become Total Quality Management (TQM). According to Wikipedia, the concept of TQM “…consists of organization-wide efforts to install and make a permanent climate in which an organization continuously improves its ability to deliver high-quality products and services to customers.” Since a CAPA system is part of TQM, it needs to provide functionality that supports compliance with internal and external quality governance. 

Life Sciences - How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process
How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process

This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.

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Over the next 6 blog posts, we’ll specifically address how Oracle’s drug safety and pharmacovigilance system, Argus Safety, can help you comply with the following CAPA rules: 

  1. System must provide workflow configuration to handle internal quality control, quality assurance and/or quality management issues
  2. System must be able to uniquely identify complaint cases
  3. System must be able to attach supportive information to the case data
  4. System must allow the recording of issues and track their resolution to completion either in the form of Corrective, Preventative or both action types
  5. System must produce ad-hoc descriptive statistical reports on quality data
  6. System must comply to 21 CFR Part 11



Evolution from Quality Control to Total Quality Management

To read other posts in our “Argus Safety for CAPAs” series, click here.

About the Author

Dr. Rodney Lemery specializes in the implementation, support, and development of software used in the collection, management, and analysis of clinical data. His accomplishments as director of safety and pharmacovigilance at Perficient include the management of numerous clinical application implementation projects. In addition to his expertise in clinical and safety applications, Rodney is able to navigate between the technical and clinical worlds with ease due to his complementary educational background in epidemiology. He also holds a part-time professorship in the School of Health Sciences at Walden University, which solidifies his ability to lead global safety implementations at Perficient. Rodney has been with Perficient, via the acquisition of BioPharm Systems, since 2000. Prior to joining the company, he worked at Pfizer.

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