Equipment Validation, Laboratory Information Systems and R&D

The variety of our experience and the expertise of our consultants in terms of laboratory activities, allows us to accompany you throughout the execution stages of a validation project, as well as in the elaboration of a system scope statement until its official start-up. CVO-EUROPE has developed a Validation expertise unique in all of Europe, acquired over more than 250 projects. Our experience has  allowed us to elaborate efficient methods and a pragmatic validation process.

 

 Our offer

 

Project Management (Conception and Validation)

  • Project Guidelines and Positioning
  • Project Planning
  • Project Steering

 

Development Documentation

  • Scope Statement, User Requirement Specifications (URS)
  • Functional Specifications (FS)
  • Detailed Specifications System Design Specifications (SDS)
  • Mechanical/ Environmental Specifications
  • System Architecture
  • Flow-based laboratory activity Analysis and Optimization
  • Conception Review (QD, QC, RCE)
  • Evaluation/Categorization of criticality
  • ERES Evaluation (21CFR11, EuGMP Appendix 11, PI011)
  • Preparation of migration and deployment plans
  • Preparation of withdrawal plans

 

System Configuration:

  • System configuration in compliance to user requirements
  • Coding and verification
  • Technical Data Testing
  • Data Conversion, integration and migration

 

Validation Strategy and Policies:

  • Validation Procedures
  • Master Validation Plan
  • Validation Plan
  • Risk Analysis based on GxP regulatory requirements
  • Consideration of equipment categories (specificity, complexity) and  specifications described in(USP 1058 AIQ) Pharmacopoeia
  • Procedures: Change Control, deviation management/ System incidents, installation, administration and exploitation
  • Business continuity planning (BCP) and Recovery Plan

 

Test Pans, execution, verification of executed tests:

  • Integration, acceptance testing
  • Installation qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Traceability Matrix

 

Validation conclusion

  • Management of nonconformity  (CAPA)
  • Execution Report (IQ,OQ,PQ)
  • Final Validation Report

 

Training

  • A1 - Familiarization with validation
  • A10 - Manufacturing Computerized System and Equipment Validation
  • A11 - Information System Validation
  • A50 - Laboratory systems and equipment validation
  • A18 - Automated and computerized systems supplier auditing
  • B30 - Risk Management in the health field (ICH Q9)
  • D15 - LIMS: Functionality, project management and validation
  • A40 - Computer infrastructure Qualification (Q21)

 

Auditing

  • Supplier Auditing: systems,  equipment, hosting, hotline/tele-maintenance, data center, archiving, integrator, developer…)
  • Computerized System Auditing
  • 21CFR11 Compliance