Computer System Validation

Risk-based  Qualification and Validation of Computer Systems

GxP-compliant approach is based on the requirements in EU Annex 11 and the U.S. FDA 21 CFR Part 11
 

We efficiently support you in validating your GxP-relevant computerised systems in accordance with applicable regulations.

Your advantages with Valicare's CSV expertise:

• Over 20 years of experience with CSV projects in the life science industry
• Proven, pragmatic approaches based on GAMP 5 or CSA for cost and time-efficient validation
• Comprehensive consulting for the optimal validation strategy, precisely tailored to your systems and processes
• Complete planning and execution of validation activities, from user requirements specification (URS) to final report
• Qualified team of Validation Experts for PIC/S, EU regulations, such as Annex 11, and US regulations, such as 21 CFR Part 11

Our strengths - your benefits:

• Ready-to-use CSV concepts for fast, efficient validation
• Pre-configured document templates reduce your effort
• Long-standing expertise in the regulated environment minimizes your compliance risk
• Close support by experienced experts ensures on-time, smooth project execution
• Training of your employees ensures knowledge transfer and capabilities for future projects

Our CSV service portfolio:

• Risk assessments, development of tailored validation strategies
• Drafting of specifications of user and system requirements
• Validation plans, SOPs, test cases execution and reports
• Supplier audits and management
• Document reviews 
• CSV training and hands-on workshops
• Periodical Data and Document Reviews during operation of computerised systems
• Software Updates Reviews

Whether it's an ERP system, laboratory software, production control, or document management - we always find a meaningful and compliant way to validate your systems. 

Contact us for an initial consultation and let us convince you of our computer system validation! Together we will develop a tailored CSV solution that ensures your compliance efficiently and sustainably.