Industry · Pharma

Validated systems for a GxP-regulated floor.

ERP, quality, serialization and manufacturing systems for pharmaceutical manufacturers and distributors, built to hold up to GMP audits and regulatory inspection.

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Pharma

Compliance: GMP · Part 11
Validation approach: GAMP-5
Batch traceability: End-to-end
Audit readiness: Always-on

What we do

Capabilities for pharma operations.

01
Pharma ERP
SAP, Oracle and Dynamics for batch manufacturing, costing and supply chain.
02
Quality management (QMS)
Deviations, CAPA, change control, complaints and full audit trails.
03
Serialization & track-and-trace
Aggregation, reporting and supply-chain integrity for regulated markets.
04
MES & LIMS integration
Electronic batch records with instrument and lab-system integration.
05
Computer system validation
GAMP-5 validation, IQ/OQ/PQ and 21 CFR Part 11 e-records and e-signatures.
06
Distribution & cold chain
Warehouse, temperature monitoring and distributor portals for pharma logistics.

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Validated systems for a GxP-regulated floor.

Capabilities for pharma operations.

Pharma ERP

Quality management (QMS)

Serialization & track-and-trace

MES & LIMS integration

Computer system validation

Distribution & cold chain