Program evidence
Connect each development decision to the runs, samples, methods and source records that support it.
Move the program forward. Bring the evidence with it.
Connect development runs, methods and partner records. Ask neil to investigate the evidence, prepare the handover and configure the next process in Seal.
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You:
Can we transfer process v04 to the CDMO? Compare the development runs with the engineering batch and prepare the evidence gaps.
neil
The engineering batch reports higher relative potency, but it used assay v04. The three development runs used v03. I did not find a bridging assessment in the transfer package, so I would not present the increase as evidence that scale-up improved potency.
Assay v032 L development
87%PD-031
89%PD-032
91%PD-033
Assay v04200 L engineering
94%ENG-004
No bridge between the assay versions is present. The two groups are not a single trend.
The number went up. The method changed too. The transfer decision needs the missing comparison.
About this example
A prepared conversation using fictional records, not a live query. Source buttons open the example evidence. The draft can be read and downloaded; no records are changed, shared or approved.
Keep the reasoning as the program changes.
Connect experiments, materials, samples, method versions and process decisions to the program. Ask neil to bring together the evidence behind a parameter, investigate a conflicting result or draft a transfer assessment.
Your ELN, laboratory systems and partner repositories can remain in place. Scope access to the work under review, preserve original references and keep a reported observation separate from the interpretation based on it. A slide with the latest number should not become the only history of a development decision.
Turn a development decision into work people can run.
Give neil the procedure and its evidence. It can draft the process definition, sampling records and verification cases in Seal, keeping unresolved parameters and assumptions visible for review.
Exploratory work and controlled use need different requirements. Introduce review, effective versions, qualification and validation as the intended use requires them. Retain the development history when a method or process moves into controlled use; a new status must not retroactively approve earlier work.
Own the evidence when a partner does the work.
Keep the CDMO’s report connected to the source method, selected process and transfer obligations. A received document is not the same as an accepted result or an approved transfer.
Start with one candidate and one consequential handover. Test a changed assay, a missing source file and a result that contradicts the current narrative. Ask for an output the scientist, transfer lead and quality reviewer can each inspect without reconstructing the program from folders.
Explore the configured capabilities
Development records
Keep hypotheses, methods, observations and interpretation together without applying identical controls to every stage of work.
Sample genealogy
Follow parent material, aliquots, external testing and reported results with their custody and method context.
Process definitions
Turn reviewed development knowledge into versioned instructions, sampling records and verification requirements.
Analytical transfer
Compare the method versions, standards and processing used in development and at the receiving site.
Partner handover
Track the selected transfer package, open evidence gaps, responsibilities and acceptance decisions.
AI investigation and authoring
Ask neil to investigate inconsistent evidence, draft the assessment or propose the next process configuration for review.
Explore the connected records
Questions worth asking.
Yes. Scope the records needed for the program decision and use configured connections or supplied files. Preserve the original acquisition and analysis context in its source system; link the selected evidence to the assessment and follow-up in Seal.
No. Begin with development evidence and program decisions. Introduce the controls required for each intended use as the work matures. Connecting exploratory and controlled records does not mean governing them identically.
A source-backed gap assessment, proposed follow-up and, where useful, a draft process definition or workflow. Scientists and process owners confirm the interpretation and verify the proposed configuration before operational use.
It can examine the supplied methods, standards, processing and results, and draft an assessment. Missing analytical evidence must stay visible. The responsible scientists decide whether the comparison is justified and what additional work is required.
Agree the record exchange, responsibilities and review rights. Connect the receiving process, reported results and transfer obligations to the sponsor’s selected evidence. Receipt of a package remains distinct from technical acceptance or transfer approval.
Choose one consequential handover or disputed result. Supply the relevant process, methods and source observations. Verify the references, conflicting evidence and missing records, then agree the follow-up and controlled-use requirements for the next step.
Continue into the connected work.
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Bring the next decision in your program.
Tell us about the output your team needs. We’ll show you the workflow and discuss the records and connections it would use.
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