Service RD8A
Regulatory Submission
Runs transactional. Starts when a scheduled window opens. It runs 7,459 times a week across 8 stations. 3 of those stations stop for a person and 5 are done by an agent, 2 of them on the shared spine.
Runs a week
7,459
107 in flight right now.
Stations
8
3 person · 3 agent · 2 spine
Agent share of steps
63%
Autonomy on this service is set at 63% against a ceiling of 66%.
Decisions a person makes
3
Held by VP Regulatory Science.
Touchless
64%
Share of runs that complete without anybody opening them.
Timetable against actual
2.6h
Actual 3.2h, 0.6h over the timetable.
Operations
The lane diagram
Read it left to right. more
Operations
Every station in order
The same stations as a list, with the dwell the estate records against each one and the system a station of that shape would touch.
| # | Station | Lane | Who | Layer | Dwell | Target | In flight | System |
|---|---|---|---|---|---|---|---|---|
| 1 | Map requirements | GBS | Requirement Mapping Agent | gbs | 21m | 41m | 5 | Product Lifecycle Management |
| 2 | Assemble evidence | GBS | Requirement Mapping Agent | gbs | 2h 48m | 4h 21m | 38 | Product Lifecycle Management |
| 3 | Draft dossier | Agent | Submission Drafting Agent | workflow | 15m | 36m | 1 | Product Lifecycle Management |
| 4 | Scientist review Held for a named human when the unit exceeds the submission decision envelope, when confidence falls below the floor, or when a policy clause is engaged. | Human | VP Regulatory Science | policy | 5h 52m | 8h 4m | 2 | Product Lifecycle Management |
| 5 | Counsel review Held for a named human when the unit exceeds the submission decision envelope, when confidence falls below the floor, or when a policy clause is engaged. Hands over at legal | Human | VP Regulatory Science | policy | 3h 41m | 8h 39m | 5 | Product Lifecycle Management |
| 6 | Officer sign Held for a named human when the unit exceeds the submission decision envelope, when confidence falls below the floor, or when a policy clause is engaged. | Human | VP Regulatory Science | policy | 1h 47m | 3h 28m | 5 | Product Lifecycle Management |
| 7 | Submit | Agent | Regulatory Science Orchestrator | workflow | 14m | 27m | 27 | Research Notebook and Experiment Data |
| 8 | Track | Agent | Requirement Mapping Agent | workflow | 2h 5m | 4h 48m | 24 | Product Lifecycle Management |
Operations
Run it
Change the volume, move the autonomy line, release a gate, and watch what happens to the hours in each lane and to the time it takes one run to get through. more
The simulation is arithmetic on the estate, not a queueing model. more
How it runs
Run it again, going wrong
The same unit and the same stations, broken the way the estate already records breaking. more
8 stations, walked twice
Once clean, once with the categories the estate counts
This is the same unit on the same stations, breaking. more
No break below was chosen. more
One play head, two tracks, the same scale. The clean run stops when it runs out of stations; the other one keeps going.
As written
8 stations, nothing waiting, nothing sent back
0 min of 17 hrs
now Map requirements · Requirement Mapping Agent · 21 min
As the ledger has it
the same stations, plus 7 categories the estate already counts
0 min of 47 hrs
now Map requirements · Requirement Mapping Agent · 21 min
What breaks, and where it is counted
No break below was chosen. more
What the two runs say together
7 counted categories land on this procedure. more
What this run cannot claim
These breaks are shown together on one unit so the shape of a bad day fits on one screen. more
The separation register records a duty conflict against a sub-function and a named post, not against one procedure. more
Attestations on this estate are written against intake items, not against procedures, so a step done off the platform cannot be matched to the attestation that covers it. more
Two clocks run. Worked time is the sum of the time the work is actually being done … more
Live observability
Systems this service would touch
Attributed by rule from the function's system list. more
2 systems attributed
0 of 2 returning records
Product Lifecycle Management
Siemens Teamcenter · engineering · inbound · high
7 of 8 stations attributed here · read only
Research Notebook and Experiment Data
Benchling · engineering · inbound · medium
1 of 8 stations attributed here · read only
System attribution is a rule, not a reading. more
Who runs it
Orchestration and accountability
- Orchestrated by
- Regulatory Science Orchestrator
- That orchestrator’s remit
- Owns submission work end to end inside Research & Development. Runs 3 lines across 19 stations, drains the repeatable share into the C2L tower, and holds 6 human gates.
- Accountable person
- VP Regulatory Science
- Sub-function
- Regulatory Science
- Shared spine tower
- c2l
- Hand-over points
- legal
Other services in this sub-function
2 alongside this one
What this page is and is not
This is a catalogue of the modeled estate. more