manufacturing scheduling software plans and sequences multi-step campaigns for active pharmaceutical ingredients, honouring the constraints that make API production hard: equipment trains, cleaning validation, product-to-product changeovers, intermediate hold-times and shelf-life, and quality-release timing. Bodhee does this as , rebuilding a feasible plan continuously as the plant and the lab change.
Adaptive Scheduling · API Manufacturing
API Manufacturing Scheduling
built around cleaning and hold-times.
When a cleaning validation window shifts, a hold-time expires, or QC clears a batch, Bodhee rebuilds a feasible campaign schedule in minutes across production, quality, and maintenance. Built for cGMP active pharmaceutical ingredient manufacturing.
Bodhee is the Adaptive Scheduling product family from Neewee, built for cGMP API plants. It rebuilds schedules against live constraints, alongside your MES, ERP, and LIMS.
The challenge
Why scheduling breaks in API manufacturing.
A long, multi-step API campaign runs on constraints most planning tools never model. Each gap costs capacity, yield, and scrapped intermediates.
01
Campaigns live and die on sequencing
Multi-step API campaigns must be sequenced to respect intermediates, equipment trains, and changeovers. Sequenced wrong, capacity evaporates.
02
Cleaning validation blocks the train
Cleaning validation and line clearance between products consume large blocks of equipment time, and legacy planning treats them as an afterthought.
03
Hold-times and shelf-life box you in
Intermediates carry hold-time and shelf-life limits. Miss the window and a batch is scrap, but static plans cannot see the clock.
04
QC release gates the next step
A step waits on in-process or release testing and the whole train stalls. The production plan cannot see the lab, so the delay surfaces late.
05
Production, QC, and maintenance plan apart
Three functions plan on separate schedules that cannot replan together, so a hold or a maintenance window cascades into scrapped intermediates.
How Bodhee solves it
One live schedule for the whole API train.
Bodhee holds the full train, production, quality, and maintenance on one live model, so a change in one step replans the rest automatically.
One live model of the whole train.
The full API train, production, quality, and maintenance share one live model, so a change in one step replans the rest automatically, before an intermediate ages out.
Hold-times and cleaning, honoured by design.
Hold-time and shelf-life limits, cleaning validation windows, and line clearance are modelled as first-class constraints, so the plan respects the clock instead of ignoring it.
Rescheduling in minutes, not shifts.
AI agents watch the floor and the lab, classify events, and invoke the scheduling engine within minutes, so a QC hold does not quietly scrap a batch downstream.
What it does for API plants
Scheduling built around campaigns, cleaning, and the clock.
01
Campaign and batch sequencing
The right order, every train.
- Sequence multi-step campaigns across shared equipment trains
- Honour intermediate, changeover, and cleaning constraints
- Respect equipment qualification and line-clearance status
02
Hold-time and shelf-life awareness
Beat the clock on every intermediate.
- Model hold-time and shelf-life limits as live constraints
- Flag at-risk intermediates before they age out
- Sequence to minimise waiting between steps
03
QC-release-aware replanning
The plan that sees the lab.
- Replan the train around in-process and release testing
- Sync QC analyst and instrument capacity with batch flow
- Surface release-timing risk before it stalls the train
04
Cross-functional resynchronisation
One event, one coordinated replan.
- Propagate events across production, quality, and maintenance
- Assess cross-functional impact before committing
- Configurable response modes, from advisory to automatic
Trust & compliance
Built for GxP-regulated API manufacturing.
Bodhee runs alongside your validated MES, eBR, QMS, and LIMS, and provides the technical and documentary controls your validation team expects. Compliance is achieved by the validated system at your site, not by the software alone.
ISO/IEC 27001
Certified ISMS, whole-organisation scope
21 CFR Part 11
Audit-trail-aligned, closed system
EU GMP Annex 11
Audit-trail-aligned
GAMP 5
Category 4 configured product
Data integrity
ALCOA+, append-only audit trail
Access control
RBAC with SSO and SAML
Electronic signatures are not supported by design; they are executed in your systems of record such as MES, eBR, QMS, and LIMS. Cloud-infrastructure attestations are inherited from Google Cloud Platform, not claimed as our own.
Measurable outcomes
What Bodhee delivers in API plants.
Ranges observed across regulated process manufacturing deployments. Outcomes vary by plant complexity, data maturity, and integration scope.
0–15 pp
OEE improvement
across regulated process manufacturing deployments
0–25%
Changeover efficiency
from campaign- and changeover-aware sequencing
0–20%
WIP inventory
through tighter schedule execution and less waiting
0–25%
On-time delivery
from more reliable schedule execution
Hours → Minutesrescheduling cycle time−60–80%planner scheduling effort+10–15%cross-functional capacity recovery
Bodhee runs live pharmaceutical and process manufacturing production today, across multiple sites and countries. Live deployments, not pilots.
Based on Neewee deployment observations in regulated process manufacturing.
Go deeper
Related to API manufacturing scheduling.
Where Bodhee fits across your plant, and how it deploys.
Bodhee Production SchedulingThe production scheduling engine in depth.Bodhee Quality Control SchedulingSequence the lab so release keeps pace with production.Bodhee Maintenance SchedulingCluster maintenance into the fewest disruptive windows.How Bodhee worksEvent flow and the techniques behind the schedule.Trust CenterSecurity, data integrity, and GxP posture.Case studiesOutcomes from real process plants.
Frequently asked questions
API manufacturing scheduling, answered.
The questions API planners, quality leads, and IT teams ask before a pilot.
01
Bodhee models cleaning validation, line clearance, and product-to-product changeovers as first-class constraints, then sequences campaigns to reduce them. Changeover and cleaning time appears on the schedule instead of being absorbed as hidden hours, so plans stay feasible and equipment-train capacity stays visible.
Yes. Bodhee models intermediate hold-time and shelf-life limits as live constraints and sequences the train to minimise waiting between steps, flagging at-risk intermediates before they age out into scrap.
Bodhee is audit-trail-aligned with 21 CFR Part 11 (closed system, Subpart B controls) and EU Annex 11, and ships as a GAMP 5 Category 4 configured product under shared validation responsibility. It provides data integrity (ALCOA+), an append-only audit trail, and role-based access control with SSO and .
Compliance is achieved by the validated system at your site, not by the software alone. Electronic signatures are not supported by design; they are executed in your systems of record such as , eBR, QMS, and . Full detail is on the Trust Center.
Bodhee deploys alongside your existing , , , and rather than replacing them. It reads orders, master data, quality results, and equipment status through an event-driven integration layer, and publishes schedules and recommendations back out. It integrates with systems such as SAP and Oracle.
Bodhee Quality Control Scheduling shares the same live model as production, so an in-process test, a release test, or an OOS investigation replans the downstream train automatically. Release-timing risk surfaces early instead of stalling the whole campaign.
Traditional generates a plan and holds it until the next planning cycle, so it drifts the moment a cleaning window shifts or a hold-time expires. Bodhee's continuously rebuilds a feasible plan that honours cGMP constraints and the clock on every intermediate, in minutes, not at the next planning meeting.
A typical Bodhee deployment runs 16 to 24 weeks across three phases: assessment and roadmap, plant-specific configuration and integration, then a parallel run into go-live. Every release ships with regression evidence so your validation team can run a validation-impact assessment before promotion.
Ready to schedule your API train as one?
A 30-minute tour of Bodhee for API manufacturing: the engine, the cross-functional layer, and how it fits your MES, ERP, and LIMS.