info@connexo.io

;
thumb

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

Professional Validation

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

Validation As A Service

Validation & Qualification is most important pillar for Digital Transformation.

Read More

V&Q Segments

Validation & Qualification is pivotal for Quality By Design!

Read More

Validation Requirements: Regulatory Perspective

Confirmation by examination and provision of objective evidence that software confirm to user needs and intended uses and that the particular requirements imlplemented through  software can be consistently fulfilled.

Read More

High-Level Validation Service Description

Validation & Qualification is required for entire value chain during product life cycle management!

Read More

Cost Of Poor Validation

Around 200 USFDA warning letters on Validation & Qualification Issues in last three years!

Read More

Life Sciences Projects

Our Coverage: Implementation and Validation Process of complete Range of automation Projects

Read More

System Development Lifecycle Phases

High Level systemic approach that define the System Lifecycle (SLC) phases advocated by ISPE GAMP5, shall be followed during system validation to ensure that system is implemented successfully and all the user requirements are met and tested.

Read More

Validation Methodology

“V Model” of GAMP 5 “A Risk Based Approach to Compliance GxP Computerized System”

Read More

TrackWise Implementation Services

Connexo supports clients from the project planning phase through implementation and post-implementation phases for all.

Read More

ERP Software Validation Services

We continue to help our clients meet regulatory demands from conception to go-live operation of their Automation Project.

Read More

Manufacturing System Validation Services

We provide a scalable and pragmatic lifecycle validation solution to save time and increase productivity with a seamless manufacturing process.

Read More

Laboratory System Validation Services

We ensure regulatory compliance by serving strategic validation services from simple lab systems to complex integrated laboratory system.

Read More
; ;