Computer System Validation
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' Professional Services Division 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
• Validation Planning
• Vendor Audits
• Creation of SOPs
• IQ (Installation Qualification)/ OQ (Operational Qualification)/ PQ (Performance Qualification) Protocols, Scripts and Execution