Focus On Quality - Validation of Spectrometry Software: The Proactive Use of a Traceability Matrix in Spectrometry Software Validation, Part I: Principles

摘要

Tracing requirements from a user requirements specification throughout the life cycle is not only a very effective business tool to save time and effort in validation projects but also a regulatory expectation. This first installment of a two-part column series looks at the principles of a traceability matrix. The various columns on validation of spectrometry software over the last few years have covered many topics ranging from user requirements specifications to validation master plans, but requirements traceability and a traceability matrix have not yet been discussed. Traceability of user requirements in the validation of computerized systems, and spectrometry software in particular, is a regulatory expectation of the FDA as evidenced from their Guidance for Industry on the General Principles of Software Validation (1). In Europe, if the proposed update to the GMP Annex 11 regulations covering computerized systems is approved then it will become a regulatory requirement (2). This column will look at what a traceability matrix is, its role in a validation project, and when this document should be written. From my perspective, a traceability matrix is a very useful tool to help you control the detailed steps of any spectrometer computer validation project.