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It includes document control identifiers, preparation and distribution information, and describes validation support services across the software life cycle with emphasis on risk assessment and compliance. The text outlines sample validation project speed improvements, experience with regulated-company compliance requirements, and introduces FastVal, ExcelSafe, Part 11 Toolkit, advisor, and assessment tools supporting electronic records and signatures. 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AS A SAMPLE VALIDATION DOCUMENT  \n\n| Ofni Systems: Example Validation Spreadsheet\u003Cbr>Functional Requirements Specification |  | Doc. \\# : FRS-001 Rev. \\# : 0 |\n| --- | --- | --- |\n| Department: Validation | Author:\u003Cbr>Daniel Waterman, Validation Manager , Of ni Systems | Page 2 of 14 |\n\nThank you for downloading this sample validation document.  \nOf ni Systems can validate all of your software , databases , spreadsheets and computer systems , and develop the appropriate documentation for all phases of the software life cycle. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package. Of ni Systems will perform risk assessments to focus the validation effort on the most appropriate sections of your system.  \nThese sample validation documents were produced with the FastVal Validation Document generator software, which allows us to complete validation projects in 70% less time than traditional validation methods , with more time spent testing your software and less time preparing documentation. Our goal in all software validation projects is to improve the quality and value of your computer system.  \nOf ni Systems validation specialists have experience working within the compliance requirements of established regulated companies. Our specialists are experts in industry validation standards and will produce validation documents which will meet or exceed your exacting standards.  \nOf ni Systems is a leader in providing regulatory compliance solutions for pharmaceutical, biotech and medical device companies. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal validation software for generating and executing validation documents , and have been providing professional validation services using FastVal since 2006. Their products for Part 11 compliant databases and spreadsheets are used by  \npharmaceutical, 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.  \nHow can we help you? Contact Of ni Systems at by email or by phone (919) 844-2494.  \nTools for Compliance Consulting and Services  \nFastVal  \nProduce validation documents , manage validation projects and execute testing protocols electronically in 70% less time.  \nExcelSafe  \nMakes existing MS Excel spreadsheets compliant with all the technical requirements of 21 CFR Part 11.  \nPart 11 Toolkit  \nTransform MS Access programs into powerful, secure systems that meet all requirements of Part 11.  \nPart 11 Advisor  \nAssess all of your computer systems for compliance, perform gap analysis and create corrective action plans.  \nPart 11 Assessments  \nDetermine the compliance status of your computer systems.  \nComputer Validation  \nValidate new or updated software, database and computer systems.  \nCustom Programs  \nDevelop a compliant computer system specific to your requirements.  \nData Migration  \nConvert existing legacy data to an Access or SQL Server database.  \nCompliance Training  \nLearn to build a fully Part 11 compliant electronic record system.  \nDISTRIBUTED BY OFNI SYSTEMS, INC. AS A SAMPLE VALIDATION DOCUMENT  \n\n| Ofni Systems: Example Validation Spreadsheet\u003Cbr>Functional Requirements Specification |  | Doc. \\# : FRS-001 Rev. \\# : 0 |\n| --- | --- | --- |\n| Department: Validation | Author:\u003Cbr>Daniel Waterman, Validation Manager , Of ni Systems | Page 3 of 14 |\n\nSIGNATURES  \n\n| Author:   Signature:   |  | Date: |  |\n| --- ","cbCaito9ESTbUGaM","https://ap.wps.com/l/cbCaito9ESTbUGaM","pdf",176158,"English","# Introduction\n## Objectives\n## Scope\n## Assumptions\n## Exclusions\n# Acronyms and References\n## Acronyms and Definitions\n## References\n# Spreadsheet Description","[{\"question\":\"What is the purpose of this Functional Requirements Specification document?\",\"answer\":\"It defines functional requirements for an example validation spreadsheet serving OFNI Systems.\"},{\"question\":\"Which validation services and documentation support are described in the document?\",\"answer\":\"It describes performing validation activities across software life-cycle phases, including executing test scripts and writing the validation package, with risk assessments to focus effort.\"},{\"question\":\"What tools are listed for compliance consulting and services?\",\"answer\":\"The document lists FastVal, ExcelSafe, Part 11 Toolkit, Part 11 Advisor, Part 11 Assessments, and other related validation and training offerings.\"}]","FUNCTIONAL REQUIREMENTS SPECIFICATION - FOR EXAMPLE VALIDATION SPREADSHEET OFNI SYSTEMS | PDF",1789153237]