Xybion Validation Solutions

Xybion offers complete life cycle validation services for computer and laboratory systems; assessment, implementation, integration, maintenance, upgrades and retirement. We have extensive experience with systems for manufacturing, quality assurance, document management, research and design, preclinical trials and others. Validation should be considered and built into system deployment initiatives at the earliest point possible. Validation of COTS systems is not simply IQ/OQ/PQ but requires a clear set of traceable user requirements to ensure that the system performs according to its intended use.

 

The benefits of good software validation are clear:

  • Software Quality Assurance
  • Increased Software Reliability
  • Increased Usability
  • Decreased Software Failure Rates
  • Reduced Regulatory Risk
  • Reduced Long Term Costs
 
Xybion offers a comprehensive portfolio of Validation services in several key industries such as Life Sciences.  
 
Our Validation experts ensure your software solutions and equipment meet the stringent requirements necessary for each specific industry.
 

System Expertise

 
In a compliant environment, it is imperative that all of your systems be verified and validated regularly. Xybion  provides validation services for systems and equipment with minimal impact to your daily activities.  A sample of the systems and equipment our team can work with you to ensure compliance and validation is listed in the table below.
 
Enterprise Systems
  • Electronic Content Management System (ECMS)
  • Enterprise Asset System (EAM)
  • Computer Maintenance Management System (CMMS)
  • Enterprise Resource Planning (ERP)
  • Manufacturing Execution Systems (MES)
  • Quality Management System (QMS)
  • Electronic Comprehensive Technical Document (eCTD)
  • Laboratory Management System (LMS)
  
Laboratory Systems
  • Research & Design
  • Quality Assurance/Quality Control
  • Clinical Development
  • Instruments / Equipment 

 

Automation & Control

  • Programmable Logic Controller (PLC) 
  • Data Control System (DCS)
  • Building Automation System (BAS)
  • Heating Ventilation Air Conditioning (HVAC)
  • Supervisory Control and DATA Acquisition 
  • SCADA)
  • Equipment
  • Packaging Lines
  • Manufacturing equipment (autoclaves, process control skids)
  

 

Product Deliverables

  • Computer Systems
  • Validation Plans
  • Requirement Specifications (URS/FRS)
  • Design Specifications
  • Risk/Compliance Analysis
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Traceability Matrices, SOPs, Work Instructions and User Manuals

 

Infrastructure 

  • Gap Analysis Audit 
  • Infrastructure Compliance remediation
  • Inventory Assessment
  • Network Design
  • Life Cycle Documentation
  • IT Security
  

 

Process Validation & Equipment Qualification

  • Batch Record Review
  • Acceptance Testing Protocols (factory and site)
  • Facility/System Design Review
  • Vendor Acceptance Testing
  • cGXP Support Services

 

Xybion strongly believes that achievement of high levels of compliance can also make good business sense. Validation is an essential quality assurance element and must be approached with proper due diligence to achieve desired results. Validation does not have to be painful. Through careful planning you can establish and maintain your system in a ready state of compliance. Amadeus can help you define and complete your validation projects on time and within budget through our services and technology solutions.  For more information on this valuable service, please contact us for further consultation.

  

 

 

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