Analytical Method Validation
How a method is shown to be fit before it is used to release anything. Specificity, linearity, accuracy, precision, and limits of detection and quantitation.
Document control
| Document reference | LZ-SOP-QC-09 |
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| Revision | 2 |
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| Effective from | September 29, 2025 |
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| Next review due | September 28, 2026 |
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| Document owner | Quality Control |
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| Covers | Method validation |
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Provisions
- Each release method is validated for specificity, linearity, accuracy, precision, range, and limit of quantitation
- System suitability criteria are defined per method and must pass before sample results are accepted
- Compendial methods are verified as suitable under our own conditions rather than assumed transferable
- Method changes are handled under change control and require revalidation of the affected characteristics
Scope. This document forms part of the Lyze Labs quality system and applies to
research reference material supplied for in vitro laboratory use. It is not a
marketing authorisation, a regulatory approval, or a claim that material may be used
in humans.
Document control. LZ-SOP-QC-09 is an internal controlled document reference in
the Lyze Labs namespace. It is not an accreditation or certification number issued by
an external body. A superseded revision is archived rather than destroyed, so what was
in force on any given date can be established.
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