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Methods

Describe validated analytical procedures, including LC–MS/MS conditions, sample preparation, calibration, and data analysis.

Raw-data records

Maintain chromatograms, mass spectra, peak information, instrument files, and sample results.

Developing a Documentation System

A documentation system is a structured way to create, organize, control, and store all laboratory documents so that work can be performed consistently and results can be easily traced. For an LC–MS/MS laboratory,

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SOPs

SOPs – Provide step-by-step instructions for routine activities such as instrument operation, maintenance, and sample preparation.

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Protocols

Describe specific experimental procedures and study plans.

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