Method development record
- Purpose
- Attribute, matrix and intended decision
- Experiments
- Factors, source results and interpretation
- Controls
- Preparation, suitability and processing
Carry the method from development into routine use.
Connect analytical development, validation, transfer and routine execution in Seal. Keep the intended use, procedure version and supporting evidence with every method decision.
Explore this workflow
From an analytical question to a routine result.
The method is more than its procedure document. Connect intended performance, development knowledge, qualification work and the execution that produces each reportable result.
Routine performance informs method change.
Carry the analytical purpose into the method.
Record the analytical target profile (ATP) where used: intended decision, matrix, range and required performance. Connect development experiments, risk assessments and robustness work to the preparation, instrument and calculation controls they inform.
Select the procedure and performance claims to assess. Preserve exploratory results and limitations alongside the chosen approach.
Run the study against its agreed design.
Configure the applicable performance characteristics, preparations, replicates, factors, analysis and acceptance criteria before execution. Keep source files, calculations, invalid runs and protocol exceptions with the resulting assessment.
Retain the procedure, data and calculation versions supporting the claim. A repeat or reprocessed result does not erase the original.
Analytical validation study
- Design
- Characteristics, factors and acceptance
- Execution
- Preparations, sequences and source data
- Assessment
- Supported claims, limitations and review
Make local readiness part of the transfer.
Agree the receiving-lab strategy and its rationale. Coordinate shared samples, standards, instruments, analyst training and comparative work. Record local differences and discrepancies rather than treating a document handover as proof of readiness.
Review suitability for the receiving lab’s intended use. Validation, verification and transfer remain distinct assessments.
Method transfer package
- Strategy
- Scope, rationale and acceptance
- Readiness
- Equipment, materials and trained analysts
- Evidence
- Local execution, comparison and discrepancies
Keep the method version with the result.
Execute the effective preparation, suitability, acquisition, calculation and review workflow. Retain actual standards, reagent and column lots, instrument identity and processing context. Review routine performance by method version and relevant source population.
Assess signals and proposed changes against affected claims, specifications, studies, laboratories and training before implementation.
Routine analytical record
- Assignment
- Sample, specification and method version
- Actual use
- Preparations, materials and instrument
- Performance
- Suitability, invalid runs and investigations
Can the receiving lab use the new method version?
A revised procedure and a sending-lab study are available. The receiving lab still has an open comparability assessment. The method version alone does not answer the readiness question.
AM-018 / method lifecycle
Procedure
AM018-DEF- Current procedure
- AM-018 / v03
- Candidate
- AM-018 / v04
- Change state
- Proposed
AM-018 v04 is a proposed procedure revision. The intended use and change rationale belong with the preparation, acquisition, processing and suitability instructions.
What follows
Review the procedure comparison and the performance characteristics affected by the change.
Prepare the method transfer readiness review.
neil
AM-018 v04 is still proposed. The sending-lab study is available, but QC South’s comparability assessment remains open. I would carry the development knowledge forward without marking the method transferred.
AM-018 / receiving-lab readiness
DraftComplete the receiving-lab evidence review and procedure-change assessment before deciding routine-use readiness.
Method owner
Review the v03-to-v04 change and affected performance characteristics.
Analytical lead
Confirm the scope and applicability of AMD-018.
Receiving QC lead
Complete TR-018’s agreed comparison and readiness decision.
Keep the detail that matters.
Preparation is part of the method.
Carry standards, sample preparation, column requirements and processing settings with the procedure.
Retain actual lots, concentrations, quantities, timings and calculations in the execution record. A result without its preparation and processing context is not the full analytical record.
Routine performance informs the next change.
Keep suitability failures, invalid runs, investigations and method revisions in one reviewable history.
Review patterns against the intended use and source population. Keep reprocessing and retesting distinguishable from original results. A trend can trigger investigation without proving a cause.
Connected to the surrounding work.
Keep specialised systems where they belong. Agree the source of each record, the permitted actions and the reconciliation at each handoff.
Explore integrationsBefore you get started.
No. Their purpose and required evidence differ. Agree the applicable strategy for the procedure, intended use and receiving laboratory rather than treating the labels as interchangeable.
Q14 addresses analytical procedure development and lifecycle knowledge; Q2(R2) addresses validation. Seal connects the work and evidence. Your team determines the applicable performance characteristics, criteria and assessment.
Yes. Preserve the acquisition and processing records in their source system and scope the links or transfers needed for the workflow. An imported result does not replace the original record.