Many critical regulated processes in life sciences remain unsupported by out-of-the-box ServiceNow functionality — leaving organizations to rely on disconnected applications, spreadsheets, and email to manage compliance-sensitive workflows. ProcessX – Part 11 bridges that gap, enabling Part 11 compatibility across any ServiceNow flow.
ProcessX – Part 11 is a fully validated application built natively on the ServiceNow platform. It extends ServiceNow's eSignature and audit trail capabilities to meet the requirements of 21 CFR Part 11, EU Annex 11, PMDA ER/ES, and other global regulatory frameworks — without the need for additional infrastructure or custom development.
Built on over 20 years of regulatory compliance expertise, ProcessX – Part 11 is engineered to reduce the cost of quality, increase operational productivity, and accelerate digital transformation by simplifying validation and eliminating compliance bottlenecks.
ProcessX Part11 delivers fully validated, 21 CFR Part 11 compliant eSignatures and audit-ready reporting — all natively built on the ServiceNow platform.
• Compliant eSignatures & Audit-Ready Reports — End-to-end validated eSignature workflows and reports designed to meet Part 11 requirements out of the box.
• eSig Configurator — Easily define which out-of-the-box (OOB) ServiceNow tables and conditions require Part 11 compliant eSignatures, with no custom development needed.
• Detail Report Configuration — Flexibly define report content, layout, and the specific record conditions under which Detail Reports are made available.
• Built on Now — Certified & Designated — A native Built on Now application holding the highest technical designation and certification available for ServiceNow Technology Partner applications.
• Maximize Your ServiceNow Investment — Extend your existing ServiceNow environment to support both GxP and non-GxP use cases without additional infrastructure or IT overhead.
The ProcessX Part11 v0.1 release marks the initial introduction of 21 CFR Part 11 capabilities across all out-of-the-box ServiceNow processes and core system functionality. This release includes the ability to configure audit-ready Detail Reports for standard out-of-the-box workflows.
eSignature with Meaning of Signature
• Enable eSignature with Meaning of Signature for out-of-the-box ServiceNow tables
• Allow administrators to define which tables require eSignature enforcement
• Configure custom Meaning of Signature choices per business process
• Configure eSignature display values for end-user clarity
Detail Reports for ServiceNow Records
• Enable audit-ready Detail Reports for out-of-the-box ServiceNow records
• Allow administrators to configure report layout and control accessibility settings
ServiceNow Platform: Zurich or later
Required Plugins / Dependencies:
• Electronic Signature (Approval with eSignature)
User Roles:
• System Administrator — Required for installation and initial configuration
• ProcessX-Part11 Admin — Assigned post-installation for ongoing administration and end-user management
Browser Support: Latest versions of Chrome, Firefox, and Microsoft Edge, per standard ServiceNow requirements
Additional Notes:
• A USDM Cloud Assurance subscription is recommended to ensure continuous compliance and automated validation coverage during platform upgrades.
• Organizations operating in GxP-regulated environments should complete all required qualification activities before deploying to production.
Other Requirements:N/A