Pharmaceutical Industry

Smart Digital Approach to Highly Regulated Industries

The Konektom Platform brings all processes carried out under high regulatory pressure in the pharmaceutical industry to a central, secure and auditable structure. It digitalizes production, quality control, stability, microbiology, documentation and laboratory management in an integrated manner with its infrastructure fully compatible with GMP, FDA, ISO and similar standards.

Traceability of processes, audit preparation and data security are supported by the business intelligence and digital log systems offered by the platform. Thus, all stages from R&D to the final product are taken under end-to-end control, efficiency increases and compliance with regulations becomes sustainable.

Why is Digitalization Important in the Pharmaceutical Industry?

The pharmaceutical industry is one of the most sensitive sectors in terms of quality, safety and regulation. Under the high audit pressure required by standards such as GMP, FDA, ISO, process management with manual systems is no longer sustainable.
Konektom Platform eliminates these difficulties with its digital solutions specially developed for pharmaceutical companies; it provides audit compliance, process traceability and data security under a single roof.

End-to-End Process Management with Connectome

Thanks to Konektom's modular and integrated structure, all processes from production to quality, from laboratory to R&D are digitalized.

Error-free production via MES and MOM systems with digital work instructions and production records
Full digital monitoring of stability, microbiology and analytical tests with LIMS
Control of document management, CAPA, audit and training processes with QMS
Secure archiving of equipment and operation records with e-Logbook
Instant analysis of performance, quality and production data with BI

100% Compliance with Regulations

Konektom offers a digital foundation that eases the regulatory burden for pharmaceutical companies with its infrastructure that fully complies with standards such as GMP, GAMP5, 21 CFR Part 11, ISO 9001 and PIC/s.

Electronic signature and audit trail
Authorization, access management and user-based control
Version and change management
System records in accordance with validation documentation.

This facilitates audit processes and eliminates penalty risks.

Validation and Audit Assurance

All our systems are designed according to GxP principles and validation requirements.
Every step from software development to user testing is auditable and documentable. In this way, your systems are safely represented in both internal and official audits.

Digital Quality and Product Life Cycle

Connectome offers a holistic approach covering every stage of drug development:

Method development and analysis records during the R&D phase
Digitization of post-clinical production recipes
Planning and monitoring stability processes with LIMS
Post-licensing change management, documentation and CAPA processes

Thus, the entire life cycle of your product is transferred to the digital environment in a safe, fast and traceable manner.

Digital Integration in Critical Processes

Konektom is a platform where all modules work integrated.

Thanks to MES ↔ ERP ↔ LIMS ↔ QMS ↔ BI integration, data is automatically transferred between systems.
Environmental monitoring (BMS) with ambient temperature, humidity, particle tracking
Uninterrupted production with equipment performance and maintenance plans (EAM)
Strong commercial operation with after-sales representative tracking and bonus calculations (SPM)

A Real Life Application Example

In the project we carried out with one of Türkiye's leading pharmaceutical companies;

The production process was digitized with MES and MOM
Stability and microbiology processes are centered with LIMS
Document and CAPA management integrated with QMS

Result: Production traceability increased by 40% and audit time shortened by 35% within 6 months.

Our Special Applications for the Pharmaceutical Industry

Solutions we offer specifically for the pharmaceutical industry via the Konektom platform:

ERP – Supply, production, inventory, cost management
MES – Instant production monitoring, downtime management, OEE
MOM – Recipe management, digital work instructions
LIMS – Stability, microbiology, test methods
QMS – CAPA, audit, document and training tracking
e-Logbook – Operational records, equipment logs
BMS – Temperature, humidity and environmental monitoring
EAM – Equipment, calibration and maintenance management
SPM – Sales team management, bonus and quota tracking
BI – Integrated analysis of data from all systems

Why Centra?

16+ years of industry experience
Development structure suitable for validation processes
GMP, FDA, ISO and PIC/s compatible system architecture
Modular platform developed specifically for the industry
Fast installation, easy use, sustainable infrastructure

Discover the Konektom Platform!

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