ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Quality Assurance (QA)

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

Publication Source: Committees on Human Research

Quality Assurance (QA)

(ISO) The planned systematic activities necessary to ensure that a component, module, or system conforms to established technical requirements.

Publication Source: GAMP® Good Practice Guide: IT Infrastructure Control and Compliance

Publication Date: 2005

Quality Assurance (QA)

All actions that are taken to ensure that a development organization delivers products that meet performance requirements and adhere to standards and procedures.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

Quality Assurance (QA)

The policy, procedures, and systematic actions established in an enterprise for the purpose of providing and maintaining some degree of confidence in data integrity and accuracy throughout the lifecycle of the data, which includes input, update, manipulation, and output.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

Quality Assurance (QA)

The actions, planned and performed, to provide confidence that all systems and components that influence the quality of the product are working as expected individually and collectively.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

Quality Assurance (QA)

(ICH Q7) The sum total of the organized arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained.

Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities

Publication Date: 2004

Quality Assurance (QA)

The activity of or group responsible for ensuring that the facility and systems meet GMP requirements.

Publication Source: ISPE Baseline® Guide, Vol. 5: Commissioning and Qualification

Publication Date: 2001

Quality Assurance (QA)

The activity of, or group responsible for, ensuring that all materials, personnel, facilities, and systems are of the quality required for their intended use or role, and that effective quality systems are maintained.

Publication Source: ISPE Good Practice Guide: Technology Transfer

Publication Date: 2003

Quality Assurance (QA)

The activity of or group responsible for ensuring that the facility and systems meet GxP requirements.

Publication Source: GAMP® Good Practice Guide: IT Infrastructure Control and Compliance

Publication Date: 2005

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