Xybion Corporation
Computer System Validation, Testing & Compliance Services

End-to-end validation of GLP, GCP & GMP
IT applications

Talk to us to design a CSV workshop that suits your organization’s needs

Overview

Xybion’s Consulting offerings include customizable CSV Services, Auditing Services and Project Quality Management services to suit your needs.

Xybion Compliance Services provides superior service and expertise required to meet all of your Computer System Validation and Software Testing needs.

We have deep domain expertise in validating IT platforms, COTS products (CAT 3/4 systems) and custom-built CAT 5 systems developed using Agile, Waterfall or hybrid SDLC methodologies. Xybion’s Validation Experts have managed and executed validation projects for various computerized systems used in Preclinical, Clinical, Manufacturing and Safety verticals.

Our Process

Our Program

Our support begins with assigning a group of highly-qualified and experienced consultants to your project. We staff projects based on required expertise and scope, providing the most efficient and cost-effective Computer System Validation services possible, including –

Project Initiation & Planning

  • Project Management
  • SDLC – V-model, Agile
  • Gap Assessments
  • Risk Assessments
  • Validation Master Planning

System Requirements & Design

  • User Requirements Specifications
  • Functional Specifications
  • Design Specifications
  • Design Review 

IT System
Validation

  • Validation Planning
  • Integration / System Testing
  • Installation / Operation / Performance Qualification
  • Validation Summary Report

System
Operation

  • Continuity Planning
  • Change & Configuration Mgmt
  • Incident & Problem Mgmt
  • Periodic System Reviews
  • Best Practices Training

Our Services

Xybion offers superior service & expertise required to meet all of your
Computer System Validation & Software Testing
, including but not limited to –

End to end validation of GLP, GCP & GMP IT applications

21 CFR Part 11 / Annexure 11 Assessment & Remediation

Project Quality
Management

Validation Protocol
Design

Validation Team Augmentation

Factory Acceptance &
Site Acceptance Testing

© Xybion Corporation 2020