Services
We are together with you every step of the way – in ensuring usability and your compliance is always our top priority.
Key Services
GxP Risk Assessment & Benchmarking
Support of inspection readiness and post audit response preparation
Life Science Software Validation & Implementation
Development & Implementation of Quality Systems
Training & Coaching
Support in Remediation plans and CAPAs
Due Diligence in M & A
Performing Internal Inspections to Ensure All Time Readiness and Compliance
Building Culture of Quality
EQMS (EDMS)
Manufacturing Execution System (MES)
Electronic Batch Manufacturing Record(EBMR)
Distributed Control Systems (DCS)
PLCs & SCADA
Environmental Monitoring Systems
Electronic Log Books
Access Control Systems
Learning Management Systems (LMS)
Warehouse Management System
Track and Trace
Barcode Scanners & Barcode Labels
GxP Audit Remediation
CSV & CSA for all GxP Systems
GxP Training
GxP Risk Assessment & Gap Analysis
Version Upgrades and Patch Management
AI Based FDA Observation Management
Data Analytics & Visualisation in line with USFDA Process Metrics Guide
Risk Based User Access Management for GxP Systems
Risk based implementations
We are together with you every step of the way – in ensuring usability and your compliance is always our top priority.
RISK BASED IMPLEMENTATIONS
Our Deployment and Implementation experts can help ensure successful integration of software and models into existing or new workflows.
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