Allied Automation

Medical Solutions

Medical Solutions

When “close enough” isn’t acceptable. Allied Automation designs, validates, and supports medical-grade automation that tightens quality, protects data integrity, and keeps product moving—from sterile production and packaging to warehousing and last-mile cold chain.

Where Medical Operations Fail—and How We Fix Them

Manual Steps = Variability

We replace human-dependent checks with validated, sensor-driven controls and interlocks.

Paper Records = Audit Pain

eBR/eDHR with secure audit trails and electronic signatures—searchable, legible, inspection-ready.

Cold Chain Fragility

Real-time temp mapping, excursion alarms, and chain-of-custody logs—no more “we think it stayed at 2–8°C.”

Serialisation Gaps

UDI/GS1 serialisation + aggregation at unit, case, and pallet. Zero ambiguity at recalls.

Cleanroom Drift

ISO 14644 environmental monitoring with deviation workflows and CAPA hooks.

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Estee Lauder Ware Automation Logo
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Outcomes That Matter

Right-first-time (RFT)

+3–10 pts via at-source verification and poka-yoke

Batch release lead time

−20–45% with eBR reviews and automated checks

Deviation rate

−25–50% through interlocks, recipe control, and SPC

 

Recall readiness

Minutes, not days—complete genealogy and serial/agg hierarchies

What Works

Your Medical Automation Stack

Cleanroom Robotics & Sterile Handling

ISO-rated pick/place, aseptic transfer, machine tending, vial/ampoule handling with validated sterilisation and change-part control.

Vision, Weigh & Inspect

Fill-level, stopper/cap presence, label OCR/OCV, print verification, particulate/surface defects, in-motion weigh-check with reject logic.

PLC/SCADA and WES/WCS for Material Flow

Deterministic controls with recipe management, line clearance prompts, and batch holds. SCADA gives alarms, trends, and shift-handovers with e-signoff.

 

MES, eBR/eDHR and LIMS Handshake

Electronic batch/device history records, electronic work instructions, sampling plans, and LIMS integrations—21 CFR Part 11/Annex 11 style controls included.

Serialisation & Aggregation

GS1/UDI printing, scanning, and parent-child aggregation at unit/carton/case/pallet—with de-aggregation workflows for rework.

Warehousing, Cold Chain & Last Mile

GMP warehouses, validated WMS bridges, temp/RH sensors, excursion alarms, and calibrated probes. Packaging automation with print-apply and tamper-evident seals.

Built for South Africa’s medical manufacturing

Medical Automation South Africa

  • Frameworks: GxP, ISO 13485, ISO 14644, 21 CFR Part 11 / EU Annex 11, WHO GDP
  • SA Context: SAHPRA expectations, POPIA-aligned data controls, power-resilient designs for load-shedding with safe-state restart
  • Validation: V-model with URS → FS/DS → FAT/SAT → IQ/OQ/PQ and traceability matrix
  • Data integrity: ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate… and then some)
  • Safety: SIL/PL-rated interlocks, light curtains, e-stops, LOTO, and documented periodic challenge tests
Automated medical system in an automated warehouse
45%

Reduced Lead Times

50%

Reduced Deviation Rate

85%

Product Quality Index

92%

Energy Generation

How We Deliver (Without Breaking Ops)

Define

URS & risk assessment (FMEA); regulatory and validation plan agreed.

Design

FS/DS, HDS/SDS, cyber & data-integrity controls; vendor selection.

Build/Test

FAT with traceable test scripts; SAT onsite; deviation remediation.

Operate

Change control, re-qualification cadence, and periodic review.

Typical timeline: 10–24 weeks from diagnostics to steady state

85%

Product Quality Index

92%

Energy Generation