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CS Assure - Digital Platform for Computer Software Assurance
Automated Software Assurance for Life Sciences
- Business Need
- Project Management
Digitize and automate your computer system validation efforts. Gives validation engineers the power to Automate: ■ Risk Assessments ■ Mitigation Plans ■ Validation testing ■ Documentation
Highlights
CUSTOMIZABLE DOCUMENTATION TEMPLATES A full set of audit-ready, automated, software validation documentation gives you confidence during internal and external audits. Documents are fully customizable using drag & drop templates.
AUTOMATED RISK DETECTION & ASSESSMENTS Automated change detection, risk assessments, and mitigation strategies give you the freedom to focus on business requirements. Classify risks as unscripted or scripted.
CONTINUOUS PROCESS-DRIVEN TESTING 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.
Provider Details
ROQMetrics is a SaaS company focused on accelerating and improving Computer System Validation in regulated industries. ROQMetrics was founded by cloud software veterans with a track record of delivering cloud solutions to some of the worlds largest Healthcare and Life Science organizations. Based in Southern California, ROQMetrics helps with all aspects of Computer System Validation (CSV) from initial assessment, framework adoption, center of excellence formation, solution delivery, coaching, and change management. Our Lean, Risk-Based, CSV practice brings compliance, collaboration, and continuous feedback and improvement to the application lifecycle, resulting in more responsive and adaptive organizations. Our Services ■ Project Management ■ Business Analysis ■ Task Management ■ Risk Identification and Mitigation ■ Issue Escalation ■ and more… Author Validation Work Stream Deliverables: ■ Validation Plan ■ Design Specifications ■ Report Specifications ■ User Requirement Specifications ■ Functional Requirement Specifications ■ IQ, OQ, PQ Scripts ■ Traceability Matrix ■ Summary Report
Pricing Details
Default Plan
$25 USD/user/month
Free trial available for 30 days