Member Since 1982
Gene Zamba Consulting Services
Computer System Validation (CSV) is mandatory for industries required to meet FDA regulatory compliance.
We deliver highly successful and cost-effective CSV.
We have experience with designing, implementing, deploying and validating electronic records and signatures – Title 21 CFR Part 11 – for manufacturing automation.
We also, provide services for both CSV and automation system integration; including and not limited to:
• Validation Master Plans
• Test Plans
• URS’s, FRS’s, DDS’s; or a comprehensive DS (Design Specification)
• Descriptions of Operation including Normal, Challenge, Recovery, and Alarm Operations
• Traceability Matrix
• IQ, OQ, PQ
• Deviation Reports during Qualification Execution
• Test Reports
• Validation Summary Reports