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. 

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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.