Pharma Sector · EAM & GxP Compliance

Digital solutions
for the pharmaceutical industry.

Sinorfi helps pharmaceutical operators manage critical equipment, GxP compliance, intervention traceability and production systems integration.

+20 yrs
Experience
+50
Consultants
+100
Projects
Silver
IBM Partner
GxP compliance maintained Pharma site · 2,100 assets
IBM
IBM Maximo EAM IBM Silver Partner 2014
Recognised expertise
IBM Maximo / MASIBM Silver PartnerConformité GxP · GMP21 CFR Part 11 · ALCOAValidation IQ/OQ/PQ
Our expertise

What we do for pharmaceuticals

Three areas of expertise, one goal: maintain GxP compliance, trace interventions and integrate your production systems.

01

Qualified maintenance & GxP assets

Production equipment, utilities and instruments in the pharmaceutical industry require qualified, documented and traceable maintenance. Sinorfi structures maintenance plans, qualified work orders and histories in IBM Maximo.

02

Regulatory compliance & traceability

FDA, EMA, ANSM, 21 CFR Part 11, ALCOA: the pharmaceutical sector imposes some of the strictest traceability requirements. Sinorfi helps document, audit and validate interventions in IBM Maximo in compliance with regulatory frameworks.

03

MES, ERP & quality systems integration

The pharmaceutical production chain relies on multiple systems: MES, ERP (SAP), quality systems, LIMS. Sinorfi connects IBM Maximo to these tools to ensure data consistency and automate maintenance-production-quality flows.

Context

The challenges of the pharmaceutical sector

The pharmaceutical sector imposes some of the strictest traceability, validation and compliance requirements. Maintenance of production equipment, utilities and instruments must be documented, qualified and audited continuously according to FDA, EMA and ICH frameworks.

Our answer

Sinorfi helps pharmaceutical operators structure their IBM Maximo assets, maintain GxP compliance, trace and qualify interventions, and connect their MES, ERP and quality systems.

Use cases

Pharmaceutical use cases

Qualified preventive maintenance (GMP)
GxP equipment maintenance plans
Intervention traceability and history
IQ/OQ/PQ validation in IBM Maximo
Utilities management (water, air, steam)
Deviation and CAPA management
MES, ERP and quality systems integration
Regulatory reporting and audit trail
Let's talk about your project

Secure your pharmaceutical compliance

Let's discuss your qualified maintenance, GxP compliance and systems integration challenges in the pharmaceutical industry.

FAQ

Frequently asked questions

Yes. Sinorfi adapts its IBM Maximo, EAM, GxP compliance, data and SI integration expertise to the sector's specific constraints.

Yes. A diagnostic or pilot helps frame the need, validate priority use cases and reduce risk before a wider deployment.