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validation-report-template.md
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1# Analytical Procedure Validation Report
3> Reports the outcome against criteria stated in the approved protocol. If a criterion here differs
4> from the protocol, that is a deviation to be documented, not an edit to be made.
6| Field | Value |
7| --- | --- |
8| Report number / version | [ ] |
9| Protocol number / version executed | [ ] |
10| Analytical procedure identifier and version | [ ] |
11| Governing framework | [ ] |
12| Execution dates | [ ] |
13| Analysts and instruments | [ ] |
14| Author / date | [ ] |
15| Technical reviewer / date | [ ] |
16| Quality unit approval / date | [ ] |
Analytical Procedure Validation Report
Reports the outcome against criteria stated in the approved protocol. If a criterion here differs from the protocol, that is a deviation to be documented, not an edit to be made.
| Field | Value |
|---|---|
| Report number / version | [ ] |
| Protocol number / version executed | [ ] |
| Analytical procedure identifier and version | [ ] |
| Governing framework | [ ] |
| Execution dates | [ ] |
| Analysts and instruments | [ ] |
| Author / date | [ ] |
| Technical reviewer / date | [ ] |
| Quality unit approval / date | [ ] |
18## 1. Summary of outcome
20| Characteristic | Criterion (from protocol) | Result | Interval reported | Met |
21| --- | --- | --- | --- | --- |
22| Specificity / selectivity | [ ] | [ ] | — | [ ] |
23| Response | [ ] | [ ] | [ ] | [ ] |
24| Lower range limit (DL / QL) | [ ] | [ ] | — | [ ] |
25| Accuracy | [ ] | [ ] | [ ] | [ ] |
26| Repeatability | [ ] | [ ] | [ ] | [ ] |
27| Intermediate precision | [ ] | [ ] | [ ] | [ ] |
29- Validated reportable range: [ ]
30- Statement of fitness for the intended purpose, and who is making it: [ ]
1. Summary of outcome
| Characteristic | Criterion (from protocol) | Result | Interval reported | Met |
|---|---|---|---|---|
| Specificity / selectivity | [ ] | [ ] | — | [ ] |
| Response | [ ] | [ ] | [ ] | [ ] |
| Lower range limit (DL / QL) | [ ] | [ ] | — | [ ] |
| Accuracy | [ ] | [ ] | [ ] | [ ] |
| Repeatability | [ ] | [ ] | [ ] | [ ] |
| Intermediate precision | [ ] | [ ] | [ ] | [ ] |
- Validated reportable range: [ ]
- Statement of fitness for the intended purpose, and who is making it: [ ]
32## 2. Response
34- Levels and replicates actually run: [ ]
35- Calibration model and weighting: [ ]
36- Slope, intercept, and their confidence intervals: [ ]
37- Coefficient of determination: [ ]
38- **Analysis of deviation from the regression line** (residual plot, lack-of-fit test, back-calculated
39 relative error per level): [ ]
2. Response
- Levels and replicates actually run: [ ]
- Calibration model and weighting: [ ]
- Slope, intercept, and their confidence intervals: [ ]
- Coefficient of determination: [ ]
- Analysis of deviation from the regression line (residual plot, lack-of-fit test, back-calculated relative error per level): [ ]
41## 3. Accuracy
43| Level | n | Mean recovery (%) | Bias (%) | Confidence interval | Met |
44| --- | --- | --- | --- | --- | --- |
45| [ ] | [ ] | [ ] | [ ] | [ ] | [ ] |
47- Approach used: [ ] reference material / spiking / orthogonal comparison
48- For impurities, basis of determination: [ ] w/w / area %
3. Accuracy
| Level | n | Mean recovery (%) | Bias (%) | Confidence interval | Met |
|---|---|---|---|---|---|
| [ ] | [ ] | [ ] | [ ] | [ ] | [ ] |
- Approach used: [ ] reference material / spiking / orthogonal comparison
- For impurities, basis of determination: [ ] w/w / area %
50## 4. Precision
52| Level | Component | SD | %RSD | df | Interval | Met |
53| --- | --- | --- | --- | --- | --- | --- |
54| [ ] | repeatability | [ ] | [ ] | [ ] | [ ] | [ ] |
55| [ ] | between-group | [ ] | [ ] | [ ] | — | — |
56| [ ] | intermediate precision | [ ] | [ ] | [ ] | [ ] | [ ] |
58- Intermediate precision factors varied: [ ] days / analysts / instruments / environment
59- Reproducibility, if performed: [ ]
4. Precision
| Level | Component | SD | %RSD | df | Interval | Met |
|---|---|---|---|---|---|---|
| [ ] | repeatability | [ ] | [ ] | [ ] | [ ] | [ ] |
| [ ] | between-group | [ ] | [ ] | [ ] | — | — |
| [ ] | intermediate precision | [ ] | [ ] | [ ] | [ ] | [ ] |
- Intermediate precision factors varied: [ ] days / analysts / instruments / environment
- Reproducibility, if performed: [ ]
61## 5. Lower range limits
63- DL, and **the approach used to determine it**: [ ]
64- QL, and **the approach used to determine it**: [ ]
65- Confirmation of the estimated limit with samples at or near it: [ ]
66- For impurity procedures, QL relative to the reporting threshold: [ ]
5. Lower range limits
- DL, and the approach used to determine it: [ ]
- QL, and the approach used to determine it: [ ]
- Confirmation of the estimated limit with samples at or near it: [ ]
- For impurity procedures, QL relative to the reporting threshold: [ ]
68## 6. Specificity and stability-indicating properties
70- Interference results: [ ]
71- Forced degradation results and peak purity / mass balance: [ ]
72- Relative response factors, and any correction factor applied: [ ]
6. Specificity and stability-indicating properties
- Interference results: [ ]
- Forced degradation results and peak purity / mass balance: [ ]
- Relative response factors, and any correction factor applied: [ ]
74## 7. Robustness
76| Parameter | Range varied | Effect on the reportable result | Conclusion |
77| --- | --- | --- | --- |
78| [ ] | [ ] | [ ] | [ ] |
80- Solution stability demonstrated over: [ ]
7. Robustness
| Parameter | Range varied | Effect on the reportable result | Conclusion |
|---|---|---|---|
| [ ] | [ ] | [ ] | [ ] |
- Solution stability demonstrated over: [ ]
82## 8. Deviations
84| # | Description | Assessment of impact | Disposition | Approved by |
85| --- | --- | --- | --- | --- |
86| [ ] | [ ] | [ ] | [ ] | [ ] |
88- Out-of-criteria individual results, and whether they were included in the reported statistics: [ ]
8. Deviations
| # | Description | Assessment of impact | Disposition | Approved by |
|---|---|---|---|---|
| [ ] | [ ] | [ ] | [ ] | [ ] |
- Out-of-criteria individual results, and whether they were included in the reported statistics: [ ]
90## 9. Raw data traceability
92Every reported number must be traceable to a retained record. A report whose numbers cannot be
93reproduced from the raw data is the finding that costs the most to remediate.
95| Reported item | Raw data location | Instrument / system | Acquisition date | Reviewed by |
96| --- | --- | --- | --- | --- |
97| [ ] | [ ] | [ ] | [ ] | [ ] |
99- Software and version used for calculations: [ ]
100- Independent unit, grouping, CI assumptions, and any unavailable statistics: [ ]
101- Calculation verification method: [ ]
102- Script outputs retained as records: [ ]
9. Raw data traceability
Every reported number must be traceable to a retained record. A report whose numbers cannot be reproduced from the raw data is the finding that costs the most to remediate.
| Reported item | Raw data location | Instrument / system | Acquisition date | Reviewed by |
|---|---|---|---|---|
| [ ] | [ ] | [ ] | [ ] | [ ] |
- Software and version used for calculations: [ ]
- Independent unit, grouping, CI assumptions, and any unavailable statistics: [ ]
- Calculation verification method: [ ]
- Script outputs retained as records: [ ]
104## 10. Conclusion and lifecycle
106- Conclusion against the ATP / intended purpose: [ ]
107- Conditions or limitations on use: [ ]
108- Ongoing performance monitoring planned: [ ]
109- Revalidation triggers identified: [ ]
10. Conclusion and lifecycle
- Conclusion against the ATP / intended purpose: [ ]
- Conditions or limitations on use: [ ]
- Ongoing performance monitoring planned: [ ]
- Revalidation triggers identified: [ ]