Automated change detection, risk assessments, and mitigation strategies give you the freedom to focus on business requirements. Classify risks as unscripted or scripted.
A full set of audit-ready software validation documentation gives you confidence during internal and external audits. Documents are fully customizable using drag & drop templates.
Using event logs, process models, and process mining techniques, CSA can compare intended use against actual usage patterns to detect risks, and recommend mitigations and/or process improvements.
Whether you’re an established life sciences firm, rising startup, or inspired entrepreneur, you can be sure you’ll find absolutely everything you need for your computer system validation.
Our goal is to help your team reduce costs and improve customer satisfaction. Our proven, pre-configured process starts with initiating a project, followed by performing a system risk assessment, developing a validation plan, and defining requirements. Formal documentation is automatically generated and routed for approval to support all of these activities.
Following requirements management, the process continues with a functional risk assessment of requirements. Risks are categorized and used as input into the scope of validation testing. Protocols are suggested and generated based on the risk scores. Formal documentation is generated and routed for approval to support all of these activities
Validation testing includes the management of scripted and unscripted tests. Tests can be automated or executed manually. Defects found during testing are routed electronically for review and approval for resolution. Test result status is easily accessible via a dashboard and the application automatically generates a validation summary report.
CSA Chatbot Journey Templatizing chatbots is a thing now with built-in industry best practices and knowledge to support key process decision points. The chatbot adoption
CSAssure helps teams organize, discuss, and execute their computer system validation in one place. Go from requirements to deployment in one system with everything you
CSAssure helps teams organize, discuss, and execute their computer system validation in one place. Go from requirements to deployment in one system with everything you
