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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

Audit & Remediation

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

GxP Audit

We have expertise in the complete chain of audit assuring product safety and quality to clients. We provide following Audit and Solutions services. Connexo team will ensure your site is ready for any regulatory inspections.

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GxP Solution Services

You can trust us for USFDA, MHRA, TGA, ANVISA, MCC, EMA and other critical Audit.

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CSV Program Development

Design, develop and successfully implement Computerized System Validation Program. Develop Master Validation Plan and other CSV related Standard Operating Procedures to define the risk based validation methodology (SDLC) as advocated by ISPE’s GAMP5. Define System Security Policies to prevent data integrity and to ensure that the system is compliance with 21 CFR part 11 and Annex 11. Define approach for Data Backup restoration verification of all GxP Computerized Systems to ensure that electronic backed-up data is Complete, Enduring and Available. Design effective Disaster Recovery Plan. To lay down the approach for periodic review of the validated GxP Computerized System to ensure that the system remains compliant with regulation, is fit for its intended use, and satisfies company procedures throughout their life cycle.

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