VALIDATION SUMMARY REPORT FOR THE EXAMPLE VALIDATION SPREADSHEET SERVING OFNI SYSTEMS RALEIGH, NORTH CAROLINA DOCUMENT NUMBER: VSR-001 DATE ISSUED: 11/12/08 REVISION: 0 PREPARED BY DANIEL W ATERMAN VALIDATION MANAGER OFNI SYSTEMS DISTRIBUTED BY OFNI SYSTEMS, INC.. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech and medical device companies across the globe, while it s products for computer validation, auditing and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures.. : 0 Department: Validation Page 3 of 12 Author: Daniel Waterman, Validation Manager, Ofni Systems SIGNATURES Author: Signature: Date: System Owner: Signature: Date: Quality Assurance: Signature: Date: REVISION HISTORY Rev 0 Description Date Approved Initial Issue.. Volume Chart Test Case 8.2: Accurate Record Generation Test Case 8.3: Program Timeouts Test Case 8.4: Audit Trails Test Case 8.5: Electronic Signature Manifestations Test Case 8.6: GenUsers Test Case 8.7: DataEntry Test Case 8.8: Managers Test Case 8.9: Administrators All sections of the Installation/Operational Protocol for the Example Validation Spreadsheet were executed and successfully completed.. References 21 CFR Part 11, Part 210, Part 211 GAMP 5 Guide for Validation of Automated Systems VCP-001, Validation and Compliance Plan for the Example Validation Spreadsheet FRS-001, Functional Requirements Specification for the Example Validation Spreadsheet SDS-001, Software Design Specification for the Example Validation Spreadsheet IOQ-001, Installation/Operational Protocol for the Example Validation Spreadsheet 4..
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