Veeva RTSM is a cloud-based Randomization and Trial Supply Management System (RTSM) developed by Veeva Systems. RTSM is delivered to end users using the Software as a Service (SaaS) model, in a single tenant architecture. Due to the SaaS architecture, all clients use the same core services that are then configured and customized as needed to meet all requirements for the project implementation.

Veeva RTSM will be used by customers to randomize patients to treatments groups defined in a clinical protocol and assign investigational medical product (IMP) or medical devices to patients as part of Life Sciences Industry requirements to support clinical trial activities.

Where to Start: System Overview for Veeva RTSM

RTSM Validation Packages: RTSM Validation Packages


The following tables outline Veeva’s processes specific to the RTSM product and RTSM services:

RTSM Product Processes

Record Type Document
Procedure Disaster Recovery SOP – RTSM (QV-32767)
System Administration SOP - RTMS (QV-34556)
Work Instruction RTSM BRD Development WI (QV-38889)
RTSM Core Validation WI (QV-38843)
RTSM Data Backup WI (QV-33396)
RTSM Disaster Recovery Test WI (QV-32768)
RTSM Product Development Lifecycle Management WI (QV-34120)
RTSM Product Disruption Communication WI (QV-38177)
RTSM Product Risk Calculation WI (QV-38842)
RTSM Production Asset Tracking WI (QV-35542)
RTSM Production Infrastructure Management WI (QV-34798)
RTSM Production System Monitoring WI (QV-34550)
RTSM Project Data Deletion WI (QV-40036)
RTSM Project Environment Provisioning WI (QV-33269)
RTSM Release Process WI (QV-31072)
RTSM Security Patching WI (QV-34890)
RTSM Server Cluster Provisioning WI (QV-35558)
RTSM Test Automation WI (QV-39169)

RTSM Services Processes

For more information on Veeva’s Services, please see Veeva Services

Record Type Document
Procedure RTSM Project Implementation SOP (PS-01054)
Work Instruction RTSM Change Management Work Instruction (PS-01063)
RTSM Kit List Creation Work Instruction (PS-01171)
RTSM Production Access Work Instruction (PS-01142)
RTSM Project Closeout Work Instruction (PS-01064)
RTSM Project Code Management Work Instruction (PS-01293)
RTSM Project Conduct Work Instruction (PS-01060)
RTSM Project Deployment Work Instruction (PS-01065)
RTSM Project Development Work Instruction (PS-01057)
RTSM Project Initiation Work Instruction (PS-01056)
RTSM Project Integration Work Instruction (PS-01058)
RTSM Project Validation Work Instruction (PS-01059)
RTSM Randomization List Generation Work Instruction (PS-01114)
RTSM Site and User Management Work Instruction (PS-01061)
RTSM User Guides Work Instruction (PS-01062)