Profile: Ofni Systems Inc. is a computer service and software company. We help companies address the opportunities present in 21 CFR Part 11, electronic records and electronic signatures. We offer proven software and consulting services in compliance with 21 CFR Part 11. Our products include FastVal, ExcelSafe, Part 11 Toolkit, GxP Auditor, Part 11 Advisor and MedWatch Reporter. Our FastVal™ validation document generator creates, manages and executes validation documents. It is a tool that automates the generation and execution of validation documents. It generates any validation document including user requirement specifications, validation master plans, user acceptance testing, risk assessments, software acceptance testing, design specifications, factory acceptance testing, traceability matrices and installation/operational/performance qualifications. It guides through the creation of functional requirements & design specifications, and allow test protocols to be created & executed electronically. It is designed to incorporate all quality guidelines, including ICH & GAMP 4/GAMP 5 and to seamlessly integrate with company's established SOPs & guidelines for computer validation. It quickly and accurately writes review & executes test protocols. It includes templates that are used out of the box/customized to match the existing corporate templates. Our software is designed to integrate with the existing spreadsheets, systems, SOPs and policies for electronic data, complementing the existing workflow. We provide businesses with consulting services to meet all of the compliance and quality needs. Our services include software & database validation, GxP compliance audits & audit preparation, compliance assessments, training, data migration, custom programming, security and program review. We help companies review their quality and compliance systems & prepare appropriate remediation plans. We also help during an audit, tracking auditor requests and observations.