Analytical development.

Configure and run analytical development protocols in Seal, from sample preparation to results and review. Use neil to help configure the work, compare AD studies and plan the next experiment.

Configure your method workflow
Illustration of a seal following a sample vial to an analytical instrument and its result.

Put the method into practice.

Configure preparation steps, sample links, calculations and review in Seal. Run each study against a protocol version, with observations and instrument results in the same record.

Reusable protocolv03

Method robustness

  1. Prepare and identify the sample
  2. Record pH, temperature and sequence
  3. Calculate resolution and review the result
Execution recordv03

AD-041-09

Buffer pH
7.2
Column temperature
35°C
Critical-pair resolution
1.2

Resolution below study criterion

Method AM-041 v03 · Review pending. Fictional record.

Configure with neil. Test with your team. Reuse the protocol.
Each run keeps its own values, evidence and history.

See protocols in Seal

A good result at the centre.
A problem at the edge.

Explore a robustness study, then follow the finding into a review your scientists can challenge.

Does the proposed operating range hold up?

Critical-pair resolution

HPLC / AM-041 v03

Buffer pH

6.87.07.2
25°C
30°C
35°C
Column temperature × buffer pH
Study criterion: resolution ≥ 1.5. Fictional results.
neil

The upper corner needs attention.

At pH 7.2 and 35°C, resolution is 1.2—below the study’s 1.5 criterion.

The nominal condition gives 1.8. I would investigate the loss of separation before carrying the full proposed range into validation.

AD-041-09 · single observation
Inspect the nine study records

Fictional study AD-041. Nominal condition: pH 7.0 / 30°C. One observation per condition, the same sample preparation, column lot and processing method. No replicate variability or full validation dataset is supplied.

RecordBuffer pHTemperatureResolution
AD-041-016.825°C2.0
AD-041-027.025°C1.9
AD-041-037.225°C1.7
AD-041-046.830°C1.9
AD-041-057.030°C1.8
AD-041-067.230°C1.5
AD-041-076.835°C1.7
AD-041-087.035°C1.5
AD-041-097.235°C1.2
Write the review. What should we test next?
neil

I’ve drafted the assessment with the failing condition retained, the evidence gaps and a proposed confirmation study.

AM-041 / Robustness assessmentDraft

Investigate the edge.
Do not approve the range yet.

What the study shows

Eight conditions meet the selected resolution criterion. One does not. The results suggest sensitivity to the tested pH and temperature settings.

What remains open

Repeatability, other performance characteristics and conditions between the tested points. These nine observations do not establish an operable region.

Read the proposed follow-up study
  1. Review the original sequence, integrations, sample preparation and instrument conditions for AD-041-09. Retain the original result and any reprocessing history.
  2. Propose independent preparations at the nominal and failing conditions, with run order and replication justified in the study plan.
  3. Assess additional conditions near the observed loss of separation. Include relevant column lots and sample matrices in the risk assessment.
  4. Reassess the proposed parameter controls against the intended use and remaining performance requirements. Submit any revised range for scientific review.
Sources: AD-041-01–09 · Method AM-041 v03

A method another lab
can understand.

Open the evidence, instructions and outstanding work together. Carry what you learned into the next protocol—not just the final procedure.

AM-041 / v03

In development

Keep the condition
that needs attention.

8 of 9 conditions meet the study criterion. The remaining result stays in the assessment.

Inspect all nine conditions →

AD-041-09

Critical-pair resolution
1.2Study criterion ≥ 1.5
Buffer pH
7.2
Column temperature
35°C

Next: confirm the edge behaviour with independent preparations and justified replication.

Development package. It does not approve the method or complete a transfer.

Develop the method.
Keep the knowledge.

From early assay development to the receiving lab. Chromatography, electrophoresis, spectroscopy and biological assays—not just one study type.

Define what the method must measure.

Connect the analytical target profile to the product, matrix, reportable result and performance needed. Give each development study a question to answer.

Keep the experiments behind the method.

Compare sample preparation, separation and detection choices with the original results. Preserve unsuccessful conditions and the reasoning behind the next version.

Know what is ready for validation.

Bring robustness, precision, accuracy and other applicable evidence into one gap review. Keep missing work visible against your team’s agreed criteria.

Give QC more than a procedure.

Carry preparation details, standards, processing settings and known sensitivities into transfer. Compare receiving-lab results before concluding the method is suitable there.

The result is only
part of the evidence.

Bring instrument exports and reviewed results together with the method, samples and standards. Keep the original acquisition and processing context accessible.

Explore connections
Instrument recordsSequences, chromatograms, spectra and processing versionsSamples & standardsPreparation, lots, methods and reviewed resultsMethod lifecycleDevelopment rationale, validation evidence and change historyReceiving-lab workTransfer strategy, local differences and confirmation studies

Questions from analytical teams.

Yes. Configure reusable protocols with instructions, fields, calculations, linked samples and review steps. Each execution retains the version used, recorded values, observations and results. neil can help prepare the configuration and analyse the resulting evidence; your team tests the workflow and defines the review and approval requirements for its intended use.
No. Analytical development (AD) can cover chromatographic, electrophoretic, spectroscopic and biological assays. The records, responses and review requirements should reflect the technique and intended use. The worked example on this page is a fictional HPLC robustness study, not a template for every method.
Start with instrument exports, method versions, sample records and reviewed results. API connections can be scoped around the systems and permitted records you need. Keep original acquisition and processing records in their source system; an imported result alone does not replace the underlying data or its review.
Connect the intended purpose, development knowledge, risk assessment, method controls and supporting studies. ICH Q14 addresses analytical procedure development; Q2(R2) addresses validation. Your team defines the applicable performance characteristics, criteria and validation work. A robustness plot or generated report does not establish validation by itself.
No. Carry the method version, sample preparation, processing settings, reference standards and development rationale into the transfer work. Record receiving-site differences and execute the agreed transfer strategy. The receiving team reviews the evidence before routine use.
Ask for a comparison of studies, a draft robustness assessment, a gap review against your target profile, or a proposed follow-up study. Keep findings tied to the supplied records and distinguish observations from hypotheses. Scientists decide which conclusions, studies and method changes to approve.
One method version, its intended use, a study or sequence export, the relevant sample and standard records, and the question you need to resolve. Agree access and source scope before connecting additional systems.

Put your method into practice.

Bring a protocol and a representative study. Configure the steps, calculations and records, test the workflow with your team, then use neil to learn from the results.

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