Many critical regulated life sciences processes aren’t supported by traditional GxP applications and are managed in spreadsheets and email. With ProcessX, you can automate any manual GxP process, delivering up to 5x speed and efficiency.
ProcessX is an intelligent, fully validated, GxP process automation application built on the ServiceNow Platform. ProcessX enhances the ServiceNow platform’s eSignature and audit trail capability to achieve Part 11, Annex 11, and other global regulatory requirements. It enables simplified, regulated workflows and processes to be harmonized and optimized while maintaining GxP compliance.
Built on 20+ years of regulatory compliance expertise, ProcessX is designed to decrease the cost of quality, increase productivity, and drive innovation by simplifying validation and accelerating digital transformation.
Use Cases:
ProcessX supports life sciences companies’ regulated IT workflows, paperless initiatives, digitalization of manufacturing, R&D, Lab, and other digital transformation business imperatives. For pharmaceutical, medical device, biotechnology, and other FDA and globally-regulated companies that need a GxP-compliant solution to manage the following events:
- GxP Process Automation (regulated/GxP and non-regulated)
- Regulated IT processes like GxP IT Change Management (ITSM), Cybersecurity Incidents (ITSM), GxP IT Incident Management (ITSM), User Access Provisioning, Periodic Review, and Regulatory Applicability Assessment (CMDB)
- Quality and compliance processes like Deviations, Audit Findings, Regulatory Applicability/Part 11 Assessments, Risk Assessments, and more
- Manufacturing and Lab Logbooks and processes to digitize the plant
- Post Market Surveillance processes, including adverse event case intake and triage, complaint tracking, and recall management
- Standard Change/Pre-approved Change Management processes
- Data driven Application Lifecycle Management (ALM)/ Validation Lifecycle Management (VLM) project in one end-to-end digitized workflow from initiation through completion
ProcessX
- Fully validated, intelligent process automation framework with Part 11 compliant eSignatures and audit trails built-in
- Intelligent Decision Tree enables smart task selection with pre-configured event types, definitions, team assignments, and checklists and includes OOTB automated quality processes based on life sciences best practices
- Task Model Configurator lets you select from existing task design patterns or quickly build new task types; no code changes required
- Native Built on Now application with the highest technical designation and certification for a ServiceNow Technology Partners application
- Leverage your existing ServiceNow investment for GxP and non-GxP use without having to increase your overhead or IT footprint
- Automated testing of infrastructure and workflows, summarized in a validation package, with a USDM Cloud Assurance subscription keeps your ProcessX application continuously compliant during upgrades