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COMPUTER SYSTEM VALIDATION
The Computer System Validation (CSV) is the first developed and core module of the system. It houses the ability to do end-to-end computer system validation completely electronically including execution, reporting, signature and traceability.
It is the only solution in the industry that has true automation that will take data that you enter in various parts of the application for your project (requirements, roles, summaries, etc.) and automatically pull them into your documents in formatted tables to significantly cut down on administration time. From automated headers, footers, table of contents, page numbering, traceability and much much more, you will experience CSV documentation like you have never imagined. Check out our sample video on requirements, test plan entry and traceability:
The process validation (PV) module is designed to streamline and automate documentation for manufacturing and process validation industry. Build upon new and current quality by design (QBD) principles, this module allows complete flexibility of master data entry and selection such that you will have a vast array of data either interfaced or uploaded at your fingertips to allow for rocket fueled project initiation and delivery. Manage all your batch data, report on out of specification (OOS), trending analysis, validation history, risk management, critical process parameters, critical quality attributes and much more. All this combined with our powerful report building engine allows you to template massive reports such as validation protocols, validation reports, and continuous verification protocols complete with graphs, statistics, and results all brought in by a few simple clicks. Data mining across successful projects can save your organization millions by using risk assessment leveraging that is based on real data analysis. Book a demo with us to learn more.