Validation

Save time, lower costs & improve productivity with DataNet's Software Validation services 21 CFR Part 11, the FDA regulation pertaining to electronic records and electronic signatures requires that your company validate electronic record-keeping systems to ensure the accuracy, reliability, and consistent intended performance of your system, as well as the software's ability to detect invalid or altered records. For many customers, the process of validating the electronic record-keeping system is complex and costly. DataNet's Software Validation services ease your burden of compliance through the following: Software Validation services - Our Solution Delivery professional services team offers years of experience in assisting Life Science customers with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of software systems. Validation Toolkit - If you prefer to validate WinSPC on your own, our Validation ToolKit will save you thousands. It includes detailed, pre-written IQ and OQ validation test protocols and scripts specifically for validating WinSPC within a federally regulated environment. >> Next: Training

 

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WinSPC software meets FDA 21 CFR Part 11 requirements for electronic signatures, traceability and more

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