LCMS Bioanalytical Assay Method Validation - Validation Report & Excel Calculation Templates

Templates Bundle - LCMS Bioanalytical Assay Method Validation

Author: Mirela Gorjanu

Publisher: Practical Pharma Science

Excellent Practical Bioanalytical Validation Package

This package combines a professionally structured LC-MS/MS bioanalytical method validation report with a practical Excel validation calculator.

It covers the complete validation workflow, including selectivity, carryover, calibration, accuracy, precision, matrix effects, recovery, stability, and regulatory compliance based on FDA, EMA, and ICH M10 guidance. The templates are clear, well organized, and suitable for learning, training, or adapting to laboratory workflows. A valuable resource for analytical scientists, bioanalytical chemists, and pharmaceutical professionals.

Bioanalytical Method Validation Report (Word doc)

Comprehensive, professionally structured, and aligned with FDA, EMA, and ICH M10 guidance. It includes document control, system configuration, validation parameters, stability studies, and regulatory conclusions in a format that resembles industry documentation.

Excel Bioanalytical Validation Calculator (Excel doc)

A complex and complete calculator complements the report well by giving users a practical tool for performing calculations rather than just reading about them.