Draft and revise the methods people run at the bench — to your own template, with hazards, version history and the documents each change touches — for a document owner and QA to approve.
Take the change — a reagent, an instrument, a revised standard — and the documents it is said to touch.
02
Read the approved versions, their revision history and the site template they have to be written into.
Reason
03
Draft the method into that template: scope, materials, steps, hazards, containment, waste route and records.
04
Work out which other documents the change reaches — linked methods, forms, equipment records and training.
05
Compare each step against the source it cites, and mark cross-references that no longer resolve.
Decide
06
Hold any draft whose hazard, containment or waste step cannot be traced to the safety source it names.
07
Route the redline, the impact list and the open questions to the document owner and QA who own them.
Out
08
Present the draft with the effective-date and training fields left empty for the people who set them.
09
Keep each version with the reason it changed, and the reviewer edits made against the draft.
→Product statement
The agent drafts, compares and routes inside the approval boundaries agreed during implementation. Approval, issue, the effective date and the training requirement stay with the document owner, QA and the lab head.
Example workflow
One method revision, end to end
AgentHuman
1Change receivedA reagent, instrument, standard or specification change, and the documents it is said to touch
2Current versions gatheredThe approved method, its revision history, the site template and the standards it is written against
3Impact worked outWhich methods, forms, equipment records and training assignments the change reaches, and what has gone stale
4Draft written and checkedSteps, hazards, containment and waste written into the template, each bound to the source it cites
No human action required
Stages 1 to 4 run without a person in the loop — the document owner is not asked to read anything until the impact list and the source checks are done. A hazard step that will not trace stops the draft where it stands.
5DecisionSplits on the source check and the confidence gate
Steps trace, template holds
Goes to the owner as a drafted revision.
A step will not trace
Held with the untraceable steps marked.
Document owner, QA and lab head
Read the redline against the impact list, the flagged steps and what could not be traced to a source.
Approve · Edit · Send back
Approved — handed back▼
6Pack assembled and filedWritten to the document system as a draft only where access and policy allow; the effective date stays empty
7Outcome evaluatedSource-check failures, documents missed from the impact list, reviewer edits and what QA sent back
Edits
Steps the reviewer rewrites or removes are counted in the evaluation.
What should not run autonomously
Human approval stays in control
Outside the boundary — human approval required8 items
Approving or issuing a controlled document.
Setting an effective date or releasing a method.
Changing a specification or an acceptance criterion.
Signing or assigning a training record.
Automation boundaryAgent acts unaided
✓Draft and redline methods into your own template.
✓Bind each step, limit and hazard to the source it cites.
✓List the documents, forms and training records a change reaches.
✓Hold untraceable steps and route the pack to the owner and QA.
Write actions run only inside the approval boundaries agreed during implementation. An effective date is not one of them.
Authorising work with a hazardous or biological agent.
Withdrawing or superseding a method in use.
Deciding that a change touches nothing else.
Changing the template, drafting rules or thresholds.
Example output
One drafted step, annotated
Everything the agent writes into the draft is attached to the version and the source it came from.
Method draft · single revised stepIllustrative example
Trigger
Document
Step
Proposed
Confidence
Effective date
Reagent supplier changed
Test method, approved version
7.2, step 4
Redlined step and hazard note
88%
Left for the owner
As receivedThe change as it was raised, beside the approved version it lands in — nothing on this side is drafted.
Evidence usedApproved version readSupplier safety data sheetTemplate and house rules
Why the hazard line movedThe new safety data sheet carries a different hazard statement for that step.
ActionApproveEditSend back
What the score decidesBelow the configured threshold the step is held for the owner instead of entering the draft pack.
Value
Where AI adds value
The same four claims, placed at the point in the workflow where each one applies.
Where the value landsValue 01 – 04
Every document a change reachesFrom your document system
03Drafting & impact
Apply your template and standards
Use the site template, the house drafting rules, the current versions and the sources each step cites.
01Approved path
Start review from a real draft
The redline, the impact list and the sources arrive together, so a document owner opens something they can check rather than an empty template.
02Human review
Put QA on the steps that will not trace
Steps with no traceable source, cross-references that no longer resolve and stale linked documents are marked for a named reviewer.
04Build an evidence trail
Retain the change as raised, the versions read, each drafted step with its source, the impact list, the confidence and every reviewer edit — on both paths.
Integrations
Typical integrations
Five system groups connect to the same agent. Which of them are in scope is decided in discovery.
A step counts here when its source check fails, or when the document owner rewrites it before QA ever sees it. Methods typed in the paper era carry cross-references that stopped resolving years ago.
Slice performance — reported separately, not only in aggregateIllustrative example
Slice
Failure rate
Lift
Lift vs. threshold
Status
Legacy paper-era methods
5.4%
2.7×
Review
Methods transferred between sites
4.2%
2.1×
Review
Multi-document change requests
3.3%
1.7×
Watch
Routine periodic-review revisions
1.4%
0.7×
Normal
Bar: rewritten-step lift vs. periodic-review baseline · scale 0–4.0× · tick marks the 2.0× review threshold2 of 4 slices over threshold
Evidence-linked improvement
An edit by QA does not stop at the draft it was made in
Nothing here closes on one revision. What a reviewer wrote instead becomes a check the drafting runs before the next redline is written.
Improvement cycle · five stagesSwitchback — the path turns at Improve and returns at Learn
01Detect
Edits and held steps gather in one kind of document.
02Diagnose
QA's edit says more about the cause than the drafting log does.
03Improve
The drafting rule, template check or source map is changed under change control.
04Verify
Affected documents are redrafted and compared against the approved text.
05Learn
What QA wrote instead is what the next draft of that step is measured against.
Learn → DetectThe return edge. A change to the template or the drafting rules is itself a change — named approver, impact assessment and a record, before the next draft is written.
Typical build scope
Twelve workstreams across six weeks
The build scope read against the delivery timeline. Week structure follows the six-week plan — discovery, versions and impact, drafting and safety binding, evaluation, integration, then production validation and handover.
WorkstreamWeek 1Week 2Week 3Week 4Week 5Week 6
01Workflow discovery and boundary definition.
02Document system and change-control review.
03Template and house-rules mapping.
04Current-version retrieval and revision history.
05Impact mapping across linked documents.
06Drafting and redline against the template.
07Hazard, containment and waste source binding.
08Owner, QA and lab-head review workflow.
09Specification and acceptance-criterion lock.
10Evaluation suite and regression drafts.
11Document-system and training-record integration.
12Observability, deployment and Agent Care handover.
12 workstreams · 6 weeks · bar shows the weeks a workstream is active — several run in parallelFinal scope and sequence confirmed in discovery
Engagement tiers
What each tier includes
Rows are the capabilities named in each tier's scope. Higher tiers include everything below them.
Capability✓ in scope · — not at this tierPilotOne method familyProductionProduction integrationAdvancedSeveral sites / document sets
Introduced at Pilot
Drafting into your own template✓✓✓
Step-to-source binding✓✓✓
Hazard, containment and waste checks✓✓✓
Impact list across linked documents✓✓✓
Specification and criterion lock✓✓✓
Owner and QA review pack✓✓✓
Baseline evaluation✓✓✓
Introduced at Production
Document-system and training-record links—✓✓
Observability and evaluation—✓✓
Introduced at Advanced
Several sites, languages and templates——✓
Multi-programme and enterprise controls——✓
Build priceFrom $5,000From $8,000Custom quote
Final build priceConfirmed after discovery based on the document system in scope, document types, revision volume, review controls, site and language coverage and deployment requirements.
Separate from buildBuild pricing is separate from recurring Agent Care, which covers managed monitoring, evaluations, incidents and verified improvements after launch.
What we need from you
What you bring, and what we build with it
Each input maps to a piece of build scope and a week in the delivery timeline.
You bringWe build with it
01Your template, house drafting rules and numbering→Template, house rules and numbering mappingWeek 1
02Where your approval boundary sits and who signs→Approval-boundary definition and review rulesWeek 1
03Access to the document system and change control→Document system and change-control reviewWeek 2
04A revision your document owner has already been through→Current-version retrieval and impact mappingWeek 2
05The safety sources your methods have to carry→Hazard, containment and waste source bindingWeek 3
06Drafts that went wrong — a missed document, a stale step→Evaluation suite, regression drafts and failure-mode testingWeek 4
07Named document owners, QA reviewers and the lab head→Review workflow, then pilot revisions and production validationWeeks 5–6
Nothing else is requiredDeployment, documentation and Agent Care handover are ours.
Delivery timeline
Four phases across six weeks
Phases are drawn over the weeks they actually occupy. Week 5 connects the document system and puts drafts in front of owners.
PhaseW1W2W3W4W5W6
DiscoveryW1
BuildW2 – W3
EvaluateW4 – W5
Pilot & LaunchW5 – W6
Week focusW1Template, house drafting rules and the approval boundary agreedW2Document system, change control and current-version retrievalW3Drafting, redlines and hazard-source bindingW4Impact-mapping tests, safety-content checks and cohort slicesW5Document-system integration, first reviewed revisions and editsW6Production validation, live revisions with QA and Agent Care handover
Reading the bandThe bars are drawn over the weeks the work is actually named in. Week 3 is the first week a draft exists; without the template and the boundary a redline means nothing.
At the end of W6A revision has been through your own document control end to end. What Agent Care watches after that is the template and the source map.
DurationSix-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.
Next step · Biotechnology AI agent
Build a protocol assistant around the document control you already run.
Show us one method, the change that last forced it open, and the pack your document owner and QA sign. Drafting is the easy half. The hard half is knowing which linked forms, equipment records and training assignments that one change has quietly aged.
