Laboratories operating under regulations of the US Food and Drug Administration must ensure that their computerized systems are validated and continue to operate in a validated state. The validation services provided by CSols' Global Solutions Group will ensure that your laboratory is not putting your entire business organization at risk. Validation Services that CSols provides include:

• 21 CFR Part 11 Compliance Assessment
• Quality Plans
• Validation Test Planning
• Supplier Audits
• Creation of SOPs
• User Acceptance Testing Protocols and Execution
• IQ (Installation Qualification) Protocols and Execution
• OQ (Operational Qualification) Protocols and Execution
• PQ (Performance Qualification) Protocols and Execution
• Test Incident Remediation
• Trace Matrix Creation and Compilation
• Validation Reports

If you would like to find out more about our computer systems validation services, please e-mail sandy.ahmed@csolsinc.com, or alternatively, contact your local CSols office.