11. Reporting

After performing a careful LC-MS validation, it is essential to document the process and results in a clear, structured report. Such documentation is important both in regulated industry as well as in academic research, where transparency and reproducibility are the key requirements. There are multiple of reasons for making such reports:

1. Operational efficiency: Detailed reports allow for consistent application of methods by different analysts, reducing variability and saving time in future projects.
2. Scientific credibility: A complete report demonstrates the robustness and reliability of the method that has been developed. It can be used to present the work that has been done.
3. Data integrity: A thorough report guarantees that the validation process is transparent and reproducible. This helps to maintain the integrity of the data over time.
4. Regulatory requirements: Accurate documentation ensures compliance with regulatory bodies like the FDA or EMA. These agencies require full traceability and justification of analytical methods.
5. Troubleshooting: Well-documented validation makes it easier to identify issues during routine analysis or audits. It serves as a reference point for method adjustments and troubleshooting.

Consequently, a careful LC-MS validation report isn’t just a formality — it’s essential for quality, compliance, and reproducibility.

The structure and level of detail in a validation report should be aligned with its intended use. For instance, academic reports may emphasize method development, highlighting both successful and unsuccessful results to inform future research. While on the other hand, industry reports often focus more on compliance, reproducibility, and operational documentation.

If there is no other particular reason for the report than simply to document the results of the validation, the report should minimally include the following:

• Analytical method description, including analytes and matrices
• Purpose of the validation
• Validation guideline followed
• Reagents (e.g. stock solutions, calibrants etc) with their origin and purity
• Instrumentation
• Info about the experiments carried out during the validation (dates, concentration ranges, samples, personnel etc)
• Summary of the validation results covering:
  • Selectivity
  • Linearity
  • Precision
  • Trueness
  • Accuracy
  • Stability
  • LoD and LoQ
  • Ruggedness, robustness
  • Measurement uncertainty
• Conclusion and statement of validity

Each of these sections can vary depending on what has been done. It is also useful to describe parameters that are not evaluated and why.

Depending on context and expected audience, the following information can greatly enhance the report:

• Detailed validation plan
• Detailed records of all experimental runs, including both failed and successful attempts with justifications.
• Method development history
• Sample handling and storage procedures
• Calculations of the results with formulas
• Calibration curves
• Analysis of proficiency testing samples
• Assessment of autosampler carryover
• Location of the original data files
• Representative chromatograms
• Additional notes or observations
• References to relevant literature or guidelines
• System Suitability Testing (main criteria for assessing method performance throughout the lifecycle)

By taking the time to prepare a well-structured, transparent LC-MS validation report, you support not only scientific rigor and compliance but also future method development and troubleshooting.