Quality Systems 101: Basic Concepts & Considerations
‘Quality Systems 101’ is part of a PHARMACEUTICAL ONLINE Guest Expert Series.
Whether you are a life science startup with a brick-and-mortar office or working as a virtual company, at some point the question comes up: Do we need a quality system? Or perhaps your question is, What is a quality system? In an effort to answer both of these questions, this article will:
- Outline the basic concepts of a quality system
- Define when to consider adding a quality system and quality resources
- Describe how to scale your quality system for your stage in development
Quality Systems in a Nutshell
A quality system can be defined as the organizational structure, responsibilities, processes, procedures, and resources needed for ensuring the quality of products and consistency of delivering services to customers. In regulated industries like the life sciences, this includes ensuring the integrity of data provided to agencies responsible for reviewing the safety and effectiveness claims of a product, and ultimately the granting of approval to market a new drug, biologic, or device.
It helps to break this definition down into individual topics. The quality system can be seen as covering the following:
The organizational chart demonstrates that the organization has the structure and resources needed to ensure consistent and compliant deliverables. The structure and resources are determined by the type of organization, the goals and objectives of the organization, and the stage of product development. Each role identified on the organization chart should have an associated job description.
A job description is a summary of expectations the organization has for each role within the company. This typically includes an outline of the type of experience, skills, training, and education determined necessary to perform the function. It also summarizes the nature of the tasks the employee will conduct. These are often developed by functional leaders, maintained in human resources files, and utilized by hiring managers to identify the appropriate job candidates.
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