A globally harmonized glossary of terms for communicating computer validation key practices

Area of Science:

• Pharmaceutical industry
• Medical device industry
• Biotechnology
• Blood banking

Background:

• A diverse range of sources, including industry groups, regulatory guidance, and individual publications, have contributed to the development of computer validation terminology.
• The lack of harmonization among these sources has resulted in multiple, often conflicting, glossaries.
• This inconsistency in terminology creates confusion and hinders effective communication regarding computer validation.

Purpose of the Study:

• To establish a unified, global glossary of terms for computer validation.
• To address and resolve the confusion arising from disparate terminology in the pharmaceutical, medical device, biotech, and blood bank industries.
• To facilitate clear communication and understanding of key computer validation practices.

Main Methods:

• A comprehensive review of existing computer validation glossaries and terminology from various sources.
• Analysis of industry group publications, regulatory agency guidance, and computer industry terminology.
• Synthesis of terms to create a harmonized, common glossary.

Main Results:

• Development of a single, harmonized glossary of computer validation terms.
• Identification and reconciliation of conflicting or differing terminology.
• Establishment of a standardized vocabulary for industry-wide use.

Conclusions:

• A harmonized glossary is essential for clear communication in computer validation.
• Standardized terminology improves understanding and application of computer validation key practices.
• This glossary serves as a foundational resource for regulated industries.