| Records Management |
Data Governance Policy (QV-23696)
Document Management Policy (QV‑00063)
Record Retention Policy (LV‑00014) |
Document Control SOP (QV‑00084) |
Document Management in VaultQuality WI (QV‑00708)
Paper Record Management WI (QV‑04253)
Veeva Compliance Docs Distribution WI (QV‑05412)
Vault Document Management Administrator WI (QV-38036)
Process Control and Definition Overview (QV-20917) |
| Resource Management |
Resource Management Policy (QV‑00070) |
Training SOP (QV‑00085)
Employee Success SOP (EV‑00006)
Contractor Management SOP (EV‑00018) |
Vault Vlearn WI (QV-15549) |
| Change / Configuration Management |
Change Management Policy (QV‑00059) |
Change Management SOP (QV‑00570) |
IT Operations Change Management WI (QV‑01885)
Product Change Requests WI (QV‑01224)
Business System Change Management WI (QV‑02693)
AMI Configuration Management WI (QV‑09302)
Product Third Party Library Maintenance WI (QV‑10301) |
| Corrective & Preventive Action |
CAPA Policy (QV‑00061) |
CAPA SOP (QV‑00081) |
Vault CAPA User WI (QV‑11761)
Vault CAPA Management WI (QV‑08590)
Compliance Impact Assessment WI (QV‑08911)
Root Cause Analysis WI (QV‑02905) |
| Computer System Validation |
CSV Policy (QV‑00060)
ERES Policy (QV‑00064) |
Computer Systems Validation SOP (QV‑00082) |
Validation Testing WI (QV‑00864)
Validation Impact Assessment WI (QV‑04576)
Business System Impact Assessment WI (QV-16026)
System Periodic Review Work Instruction (QV-27554) |
| Risk Management |
Risk Management Policy (QV‑00071) |
Risk Management SOP (QV‑00595) |
System Risk Assessment WI (QV‑04114)
Product Risk Calculation Vault WI (QV‑03905)
Product Risk Calculation CRM WI (QV‑16742)
QMS Risk Log Work Instruction (QV-39065) |
| Audit and Inspection Management |
Audit Management Policy (QV-00057) |
Audit Management SOP (QV‑00491)
Supplier Management Procedure (QV-01325) |
Audit Management Work Instruction (08174)
Supplier Management Work Instruction (QV-05351) |
| Management Monitoring and Review |
Management Review Policy (QV-00068)
Quality Manual (QV-00055)
Quality Policy (QV-00682) |
Management Review SOP (QV-06632) |
- |
| Security and Privacy Management |
Information Security Policy (QV‑00066)
Application Security Policy (QV‑00056)
Security Incident Management Policy (QV‑00072)
Physical Security Policy (QV‑00143)
Data Privacy Policy (QV‑00062)
HIPAA Policy (QV-18343) |
Information Security & Data Privacy SOP (QV‑00387)
Standards of Acceptable Use SOP (QV‑00720) Security Team SOP (QV‑11872)
Vulnerability Management SOP (QV-29594)
Network Security SOP (QV‑00622)
User Account Management SOP (QV‑00239)
Endpoint Management SOP (QV‑01142)
Security Incident Response SOP (QV‑00578)
Office Security SOP (QV‑00573)
Privacy Incident and Breach Management SOP (QV-19711)
Privacy Operations SOP (QV‑01755) |
Index of Current Security Operations Sub‑Processes (QV‑12196)
Security Patching WI (QV‑00664)
Standards of Job Roles and Accounts WI (QV‑05413)
Operations Periodic Maintenance WI (QV‑00893)
Business System Account Management WI (QV-18341)
VaultQuality Account Management WI (QV‑04350)
CMC Account Management WI (QV‑00868)
Business System Patch Management WI (QV‑18305)
Office Badge Management WI (QV‑00842)
Privacy by Design Principles WI (QV-14322) |
| Continuity, Availability, and Capacity Management |
Capacity and Availability Management Policy (QV‑04099)
Business Continuity Policy (QV‑00058)
IT Asset Management Policy (QV‑00067) |
Technical Operations (TechOPs) SOP (QV‑01055)
Business Continuity SOP (QV‑00750)
Disaster Recovery Procedure - Vault SOP (QV‑00083)
Disaster Recovery Procedure - CRM SOP (QV‑00132)
Disaster Recovery Procedure - Network SOP (QV‑01727)
Disaster Recovery Procedure - MyVeeva for Patients SOP (QV-24439) |
AWS Instance Release - CDB Workbench WI (QV-40402)
AWS Instance Release - MyVeeva WI (QV-35804)
Production Infrastructure Management WI (QV‑00867)
Production System Monitoring (AWS) WI (QV‑09924)
AWS Console Management WI (QV-15074)
Software Escrow Deposit WI (QV‑03188)
Trust Site Update WI (QV‑03187)
SLA Calculation WI (QV‑01964)
Disaster Recovery for 3rd Party Applications WI (QV-31164)
Disaster Recovery for IT Applications WI (QV-31164)
DR Test Vault WI (QV‑01788)
DR Test - Network WI (QV‑04552)
DR Test - MyVeeva for Patients WI (QV-24987)
Vault Data Backup - AWS WI (QV‑09877)
Network Data Backup WI (QV‑05519)
IT Asset Management WI (QV‑00843)
WorkStation Build WI (QV‑00668)
IT System Development Model WI (QV‑06896) |
| Incident and Problem Management |
Incident and Problem Management Policy (QV‑00065) |
Product Support SOP (QV‑00609)
Complaints Management SOP (QV-28812) |
Product Support in Zendesk WI (QV‑05841)
Global Service Center in Zendesk WI (QV-26830)
Incident Management WI (QV-35520)
Incident Report Generation WI (QV‑05438)
Product Notification WI (QV‑04640)
Product Disruption Communication WI (QV‑04993)
SendGrid Email Notification WI (QV-14371)
Egnyte File Request Work Instruction (QV-22314) |
| Product Development |
Product Lifecycle Policy (QV‑00069) |
Requirements Management SOP (QV‑00661)
Software Development SOP (QV‑00628)
Software Quality Assurance SOP (QV‑00634)
Release Management SOP (QV‑00659) |
Vault BRD Development WI (QV‑03341)
CDMS BRD Development WI (QV‑08118)
Vault Product Lifecycle WI (QV‑03314)
CDMS Product Lifecycle WI (QV‑08117)
CRM Product Lifecycle WI (QV‑06933)
Consumer Products Product Lifecycle WI (QV-37193)
Network Product Lifecycle WI (QV‑09921)
Safety Product Lifecycle WI (QV‑19337)
SiteVault PLC WI (QV-34645)
MyVeeva for Patients PLC WI (QV-23133)
Vault Test Automation WI (QV‑03357)
Test Management - Vault WI (QV‑09264)
Vault Product Release Deployment WI (QV‑00869)
CRM Release Process WI (QV‑00879)
Network Release Process WI (QV‑02087)
Vault Maintenance WI (QV‑00693)
Network MDM Maintenance WI (QV‑05391) |
| Service Portfolio Management |
Service Portfolio Management Policy (QV‑02709) |
General Administration of Customer Environments SOP (QV‑06707)
Security Administration of Customer Environments SOP (QV‑05444) |
Services Project Change Management WI (QV‑02784) |
| RTSM Processses (Non-Services) |
- |
Disaster Recovery SOP – RTSM (QV-32767)
System Administration SOP - RTMS (QV-34556) |
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) |
| CDMS Services |
- |
CDMS Project Implementation SOP (PS-00551) |
CDB Implementation and Configuration WI (PS-00723)
CDMS Customer Acceptance WI (PS-00234)
CDMS Periodic Review WI (PS-00228)
CDMS Production Access WI (PS-00508)
CDMS Project Design WI (PS-00571)
CDMS Project Implementation WI (PS-00551)
CDMS Project Initiation WI (PS-00233)
CDMS Project Verification WI (PS-00235)
CDMS Site and User Management WI (PS-00155)
CDMS Study Closeout WI (PS-00227)
CDMS Study Conduct WI (PS-00241)
CDMS Study Data Extract WI (PS-00168)
CDMS Study Deployment WI (PS-00425)
CDMS Training and Curriculum Development WI (PS-00231)
CDMS Utilities Administration WI (PS-00299) |
| SiteVault Services |
- |
- |
SV User Management WI (PS-00735)
SV Configuration Validation WI (PS-00736)
SV Change Management WI (PS-00737) |
| ePRO Services |
- |
ePRO Project Implementation Procedure (PS-01151) |
ePRO Change Management Work Instruction (PS-01158)
ePRO Project Initiation Work Instruction (PS-01155)
ePRO Device Provisioning Work Instruction (PS-01249)
ePRO Manual Data Change Request Work Instruction (PS-01035)
ePRO Project Verification Work Instruction (PS-01154)
ePRO Study Conduct Work Instruction (PS-01156)
ePRO Study Design Work Instruction (PS-01153)
ePRO Translation & Licensing Work Instruction (PS-01157) |
| RTSM Services |
- |
RTSM Project Implementation SOP (PS-01054) |
RTSM Services Process Document Map (PS-01090)
RTSM Change Management Work Instruction (PS-01063)
RTSM Kit List Creation Work Instruction (PS-01171)
RTSM Production Access Work Instruction (PS-01142)
RTSM Project Code Management Work Instruction (PS-01293)
RTSM Project Closeout Work Instruction (PS-01064)
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) |