The approach, applied to life sciences
Every regulated object your organization runs, a trial, a product, a batch, a submission, a quality event, already has a current state, rules it must satisfy, a history, and people who need a view of it. Explore the map below, then see how the approach changes the day-to-day for seven of these objects.
the landscape
Seven components, one living system
Here is how it plays out for seven regulated objects: how they are handled today, where that breaks down, and what changes with the approach from the previous pages.
| Object | Today | Limitation | Holon approach |
|---|---|---|---|
| Clinical trial | Protocol, EDC, CTMS, and TMF each hold a slice of the truth. | Reconciling them before a milestone is slow and error-prone. | One governed trial record that every dashboard and report reads from. |
| Medicinal product | Product attributes are re-entered per market and per system. | “What is the approved strength here?” can take days to answer. | One product identity that exposes the right regional view on demand. |
| Regulatory submission | Dossiers are assembled module by module, close to the deadline. | Late discovery of missing or inconsistent data risks the filing date. | Submission content generated from state that was already governed and validated. |
| Batch / lot | Release decisions are pieced together from LIMS, MES, and paper records. | Genealogy and test results are hard to trace end-to-end quickly. | A release view computed from linked, governed manufacturing state. |
| Quality event | A deviation, its investigation, and its CAPA live across spreadsheets and a QMS. | Links to the affected batch or product are easy to lose over time. | A quality event that stays connected to everything it touches. |
| Safety case | Adverse-event follow-up is tracked case by case, often by hand. | Recurring patterns across cases are hard to see in time. | A safety case that carries its full timeline and links to related events. |
| Lab result | A measured value moves through several systems before it is “official.” | Instrument provenance and review history can thin out along the way. | A result that carries its provenance and specification checks with it. |
the four graphs
Every object, expanded into its four graphs
The map above shows each object blooming into scene, boundary, event, and projection graphs. Here is the same structure as data: open any object to read the full set of synthetic instances the map animates, each tagged with its ArchiMate type.
Clinical Trial 4 graphs · 16 elements
Scene state
- Clinical Trial BusinessObject
- Protocol v3.0 BusinessObject
- Subject Data DataObject
- EDC System ApplicationComponent
Boundary rules
- GCP Compliance Requirement
- Inclusion / Exclusion Constraint
- Visit-Window Rule Constraint
- Endpoint Derivation Constraint
Event provenance
- Protocol Approved BusinessEvent
- First Patient In BusinessEvent
- Visit Completed BusinessEvent
- Database Locked BusinessEvent
Projection views
- Investigator Dashboard Representation
- Clinical Study Report Deliverable
- Submission Dataset Artifact
- Monitoring View ApplicationService
Medicinal Product 4 graphs · 16 elements
Scene state
- Product BusinessObject
- Substance BusinessObject
- Formulation DataObject
- Marketing Authorization BusinessObject
Boundary rules
- IDMP Rules Requirement
- Labeling Constraints Constraint
- Pharmacovigilance Req. Requirement
- Regional Reg. Req. Constraint
Event provenance
- Approval Granted BusinessEvent
- Variation Submitted BusinessEvent
- Label Updated BusinessEvent
- Safety Signal Detected BusinessEvent
Projection views
- EMA View Representation
- Swissmedic View Representation
- Safety View ApplicationService
- Medical Information Deliverable
Regulatory Submission 4 graphs · 16 elements
Scene state
- Submission BusinessObject
- eCTD Modules DataObject
- Source Claims BusinessObject
- Validation Status DataObject
Boundary rules
- Authority Rules Requirement
- eCTD Specification Constraint
- Controlled Terminology Constraint
- Validation Rules Constraint
Event provenance
- Document Authored BusinessEvent
- Reviewed BusinessEvent
- Submitted BusinessEvent
- Authority Question BusinessEvent
Projection views
- EMA Package Deliverable
- Swissmedic Package Deliverable
- FDA Package Deliverable
- Reviewer View Representation
Batch / Lot 4 graphs · 16 elements
Scene state
- Batch BusinessObject
- Materials DataObject
- Process Version BusinessObject
- Test Results DataObject
Boundary rules
- GMP Rules Requirement
- Specifications Constraint
- Release Criteria Constraint
- ALCOA+ Principle
Event provenance
- Material Weighed BusinessEvent
- Step Executed BusinessEvent
- Deviation Raised BusinessEvent
- Batch Released BusinessEvent
Projection views
- Batch Record Deliverable
- Certificate of Analysis Deliverable
- QA Release View Representation
- Inspection Package Artifact
Quality Event 4 graphs · 15 elements
Scene state
- Deviation / CAPA BusinessObject
- Root Cause DataObject
- Impacted Batches BusinessObject
- Evidence DataObject
Boundary rules
- SOPs Requirement
- Severity Rules Constraint
- Escalation Rules Constraint
- Approval Policy Principle
Event provenance
- Opened BusinessEvent
- Triaged BusinessEvent
- Investigated BusinessEvent
- Closed BusinessEvent
Projection views
- QA Dashboard Representation
- Audit Report Deliverable
- Management Review Deliverable
Safety Case 4 graphs · 15 elements
Scene state
- ICSR BusinessObject
- Product Exposure DataObject
- Adverse Event BusinessObject
- Causality DataObject
Boundary rules
- PV Regulations Requirement
- Seriousness Rules Constraint
- Reporting Timelines Constraint
- Coding Standard Principle
Event provenance
- AE Received BusinessEvent
- Medically Reviewed BusinessEvent
- Follow-up Requested BusinessEvent
- Case Submitted BusinessEvent
Projection views
- Regulatory Report Deliverable
- Signal View ApplicationService
- Medical Review View Representation
Lab Result 4 graphs · 14 elements
Scene state
- Sample BusinessObject
- Method BusinessObject
- Instrument Node
- Result DataObject
Boundary rules
- Acceptance Criteria Constraint
- Calibration Req. Requirement
- Data Integrity Principle
Event provenance
- Sample Collected BusinessEvent
- Analyzed BusinessEvent
- Result Verified BusinessEvent
- Result Released BusinessEvent
Projection views
- Result Report Deliverable
- Trend Dashboard Representation
- LIMS View ApplicationService
The pattern is the same for every object on this page. Case walks one of them end to end, a full clinical trial, with a live, explorable dataset behind it.