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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

Quality Service

We are together with you every step of the way – in ensuring usability and your compliance is always our top priority.

Consulting-Implementation

Adhering to industry regulations and global standards, we share the best compliance practices while catering to your internal SOPs, delivering a world-class compliant EQMS, EDMS, and LMS solution tailor-made to suit your requirements.

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Quality Strategy

Quality strategy development and organization alignment, Quality maturity model assessment development of key performance indicators for monitoring quality m&a readiness and transaction support.

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Quality Operations

Process evaluation to industry best practices Propose and implement robust and sustainable quality controls to achieve organizational efficiency and compliance Data integrity assessment and issue remediation.

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Quality Management System

QMS Framework Assessment, Design Quality Policy, SOP Development, CAPA, Deviation Management Process, Execution Complaint management, Evaluation & Design and Documentation Controls.

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Computer Systems Validation

Assessment, development and execution of a robust validation strategy focused on current regulatory standards. Evaluating the current tools, defining the future roadmap and potential integrations. Defining validation strategies for new technologies and standards.

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Quality Audit

Health assessment of Quality Management System to applicable regulations. Identification of deficiencies and implementation of quality plan to attain compliance. Mitigations to support Continuous process improvement and Risk Reduction.

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Quality Technology And Digitization

Business process and requirements definition, Technology vendor selection, Solution architecture and design Solution implementation and deployment support, Application rationalization and upgrade support.

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