Krezup provides professional Pharma & GxP Automation Solutions services.Automation and monitoring solutions for pharmaceutical environments with data integrity, controlled access, audit trails, GxP standards and validation support.We specialize in Environmental monitoring, Temperature monitoring, Warehouse monitoring for industries including URS, Functional Specification, Design Specification.

Pharma & GxP Automation Solutions

Pharma and GxP automation applies computerized control technologies to regulated environments, strictly adhering to data integrity, electronic records, and validation standards.

Krezup provides automation and monitoring solutions designed for pharmaceutical and other regulated environments where data integrity, traceability, controlled access and documented system lifecycle activities may be required.

Solutions

Environmental monitoring
Temperature monitoring
Warehouse monitoring
SCADA
Equipment monitoring
Utility monitoring
Data logging
Alarm management
Audit-trail-oriented system design
Role-based access
Electronic records
Backup and recovery
Validation documentation support

Applications & Validation Documentation

URSFunctional SpecificationDesign SpecificationRisk AssessmentIQOQPQTraceability MatrixValidation Report

Compliance-Oriented Design

GxP21 CFR Part 11EU GMP Annex 11ALCOA+ data integrity principles

Frequently Asked Questions

GxP automation applies computerized control and monitoring technologies in regulated operations while considering requirements for data integrity, security, traceability and validation.

No. Compliance depends on the complete system configuration, intended use, procedural controls, validation and organizational processes.

Yes, systems used for GxP purposes may require documented qualification or validation based on intended use and risk.

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