Methods & QC analytics
Apply test procedures consistently
Methods, instruments, and revalidation dates are maintained in the catalogue. Validation plans, results, second checks, and OOS investigations follow from it.
- Keep method, instruments, and revalidation together
- Clearly separate recording and second check
Test process
From test procedure to result approval
- 01
Maintain the method
Set the code, version, technique, instruments, and next validation date.
- 02
Run the validation
Record checkpoints, acceptance criteria, and results in the validation plan.
- 03
Check results
Evaluate readings against the specification and decision rule, then verify them independently.
- 04
Handle exceptions
Review control values and investigate OOS findings through phases 1 and 2.
Method validation
Plan, checkpoints, and report stay connected
Starting execution locks the planning data and opens the result fields. Completing execution freezes the checkpoints. The report is generated from them or uploaded separately, then released in its own step.
Routine QC
Reading, second check, and investigation in one flow
The specification evaluates the saved reading. Verification and approval remain separate steps. OOS results can open the two-phase investigation directly; control values are evaluated on the Levey–Jennings chart using Westgard rules.
Capabilities
Technical scope
LabNote.Light provides the documentation, review, and calculation tools. Technical validation and release decisions remain with the laboratory's authorised personnel.
- Method catalogue
- Code, title, version, technique, status, primary instrument, and further assigned instruments.
- Validation plans
- Initial validation, revalidation, verification, or extension with planning, execution, report, and follow-up actions.
- Acceptance criteria
- Checkpoints carry the criterion, result, assessment, and attachments; results are entered during execution.
- Measurement uncertainty
- Budgets with individual contributions, distribution, sensitivity, combined standard uncertainty, and coverage factor.
- Specifications
- Limits, LOD and LOQ, rounding, replicates, scatter, and guard band per test parameter.
- Result verification
- Open, verified, and out-of-specification results in a separate second-check queue.
- Control charts
- Levey–Jennings display with mean, standard deviation, and Westgard evaluation of control values.
- OOS investigations
- Immediate action, laboratory check, root-cause analysis, retest, affected samples, and QA-signed closure.
- Proficiency tests
- Schemes, rounds, results, and z-score evaluation within QC.
- Flexible scope
- Organise methods and parameters by the scope groups maintained in the system and document changes.
Common questions
What is the difference between a method and an SOP?
The method is the technical catalogue entry for the procedure, instruments, and validation. The SOP is the controlled document with its own version and approval. A validation plan can reference the SOP.
How are decision rules represented?
A specification can carry limits and a guard band. Evaluation distinguishes pass, fail, inconclusive, and below the quantitation limit. The database recalculates the outcome on save.
Can multiple instruments be assigned to a method?
Yes. Multiple instruments can be linked and one can be marked as the primary instrument.
What does a validation plan contain?
The plan records the validation type, SOP, dates, and checkpoints. After execution, the report is generated from the checkpoints or uploaded as a separate document, then reviewed and released.
What happens to an OOS result?
The result can open an investigation. It records the immediate action, phase 1 laboratory check, phase 2 root-cause analysis, retest, affected samples, and final decision.
How does the four-eyes principle work?
When the organisation requires result verification, approval is only available after the second check. The person who recorded the result cannot verify it.