The Future Of
Pharma Manufacturing
Most MES was written
as a system of record.
CtrlPoint was written
as an instrument.
Paper batch records were faithfully digitized. Twice. Neither pass gave manufacturing engineers what they actually needed - a live, queryable model of the plant.
We started from the operator's tablet, the equipment layer, and the audit trail - then built the record upward. What emerges looks like an EBR. It behaves like an operating system.
Electronic Batch Records
Designed For The Production Floor
Compression start-up verification
Verify that the tablet press has been cleared, configured, and released for the current batch. Confirm the approved tooling set is installed and complete the initial tablet checks before starting routine compression.
- 06:12:41ZStep 13 · Equipment setup completed - M. Okoye
- 06:10:18ZTooling set TS-500-02 verified - M. Okoye
- 06:07:52ZLine clearance approved - R. Duarte
- 06:03:26ZTablet press TP-201 assigned to B-2026-004817
- 05:58:11ZCompression phase released - Production Supervisor
Every completed action is linked to the authenticated user, signature meaning, date, and time, creating a clear and attributable manufacturing record.
Out-of-limit values and process issues are recorded directly against the affected batch step, with the original entry, justification, and follow-up actions preserved.
Critical process parameters can be captured directly from connected equipment and linked automatically to the correct batch, phase, and manufacturing step.
One Connected Platform
For Manufacturing Operations
CtrlPoint connects batch execution, equipment history, quality review, and manufacturing intelligence in one controlled environment.
Master Batch Records authored once, executed live on the floor.
Every equipment, room, and area carries its own controlled digital history.
Structured batch and equipment data becomes trend, yield, and deviation insight.
Every Equipment Event.
Recorded Digitally.
- 10 Jul · 14:21Cleaning completedSOP CLN-114 v6 · Performed A. Rahman · Verified S. Patel
- 10 Jul · 11:48Batch B-2026-004817 completedEquipment use closed
- 10 Jul · 06:03Equipment use startedBatch B-2026-004817 · Granulation phase
- 09 Jul · 17:12Pre-use inspection completedChecklist PUI-08 · S. Patel
- 09 Jul · 15:44Gasket replacedMaintenance event MT-2041 · Engineering
- 01Available
- 02In Use
- 03Cleaning Required
- 04Clean
- 05Under Maintenance
Status transitions occur automatically when the associated manufacturing activity begins, ends, or requires cleaning verification.
Every use is linked automatically to the relevant batch, operator, date, and time.
Cleaning records capture the approved SOP, cleaning details, and independent electronic verification.
Due dates, maintenance events, and equipment availability remain visible throughout manufacturing.
See The Manufacturing Floor
As It Happens
- Available18
- In Use7
- Cleaning Required4
- Under Maintenance2
- Out Of Service1
- · 2 units cleaning validity expires within 8 h
- · 1 balance calibration due in 3 days
- · 3 batches waiting for QA review
Every Manufacturing Record.
Connected.
QA can open every record without moving between systems or paper files. Line clearance links to the batch. The batch links to the equipment. The equipment links to its cleaning record. The room links to environmental readings.
- · Batch
- · Equipment
- · Room
- · User
- · Signature
- · Date & time
- ✓Previous product and labels removed
- ✓Previous batch materials removed
- ✓Area cleaned and inspected
- ✓Equipment status verified
- ✓Documents from the previous batch removed
- ✓Correct batch documentation available
Review What Matters.
Release With Confidence.
- Dispensing✓
- Granulation✓
- Drying✓
- Blending✓
- Compression3
- Coating✓
- Packaging✓
The complete record remains available for review. CtrlPoint directs attention to entries requiring quality judgement - corrections, exceptions, manual entries, and unresolved queries.
- Tablet weight outside alert limitReviewStep 15 · Compression
- Entered
- 511.2 mg
- Approved range
- 490–510 mg
- Justification
- Reading confirmed, sample retained.
- Supervisor
- Accepted with comment
- Manual parameter entryReviewStep 18 · Compression
- Reason
- Tablet press connection temporarily unavailable
- Entered by
- M. Okoye
- Late IPC readingReviewStep 22 · Compression
- Due
- 10:30
- Recorded
- 10:38
Quality teams are guided directly to exceptions, corrections, missing signatures, and unresolved queries.
Every value, signature, correction, and linked record remains available in its original context.
Release, rejection, and hold decisions follow defined permissions, checks, and electronic signatures.
From Equipment
Directly Into The Batch Record
- TP-201Tablet Press
- WB-01-B1Balance
- GR-201High-Shear Granulator
- CP-301Coating Pan
- RM-02Environmental Sensor
- Tablet WeightTP-201 · captured 06:14:22Z499.2 mg→ Compression · Step 15
- Compression ForceTP-201 · captured 06:14:22Z18.4 kN→ Compression · Step 15
- Granulation TemperatureGR-201 · captured 06:14:22Z41.8 °C→ Granulation · Step 06
- Impeller SpeedGR-201 · captured 06:14:22Z185 rpm→ Granulation · Step 06
- Room Differential PressureRM-02 · captured 06:14:22Z15 Pa→ Environmental · Continuous
When a connection is unavailable, the operator enters the value manually and records a reason. The entry is flagged for QA review.
- OPC UA
- Modbus
- REST API
- Historian
- Edge Gateway
Every value carries its equipment source, capture time, batch, phase, and step - traceable from the batch record back to the machine that produced it.
Manufacturing Intelligence
Built From Every Batch
- · Granulation moisture
- · Compression reject rate
- · Coating weight gain
- Occurrences4 in 90 days
- Affected equipmentTablet Press TP-201
- Previous CAPAEffectiveness concern
- · Increasing motor current variability
- · Two recent deviations
- · Maintenance due in 18 days
Which production line had the highest number of compression-related exceptions during the last six months?
Compression Line 02 recorded 14 exceptions across 28 completed batches. Eight were linked to tablet-weight variability.
AI supports investigation, prioritization, prediction, and reporting. Final GMP decisions remain with authorized users.
Compliance Is Not
An Add-On.
- Unique user identity
- Role-based access
- Electronic signatures
- Immutable audit trail
- Version-controlled Master Batch Records
- Reason-for-change
- Controlled review and approval
- Secure record retention
- Search and retrieval
- Locked PDF export
Designed to support compliant electronic records and signatures. Built around attributable, legible, contemporaneous, original, and accurate records. Configuration and validation remain controlled within each customer implementation.
One Platform.
Built Around The Work.
- Active batch
- My tasks
- Machine values
- Signatures
- Raise exception
- ·Verify tooling set TS-500-02
- ·Enter tablet weight (start-up check)
- ·Confirm line clearance is complete
- ·Apply performed-by signature
See CtrlPoint
In Your Manufacturing Environment
Explore how Electronic Batch Records, Electronic Logbooks, equipment connectivity, and manufacturing intelligence can work together across your operation.