| Records Management |
Data Governance Policy (QV-23696)
Document Management Policy (QV‑00063)
Record Retention Policy (LV‑00014) |
Document Control SOP (QV‑00084)
Production Data Management SOP (QV-44226) |
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)
Compliance Evaluation Work Instruction (QV-27292) |
| 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 |
ISMS Manual (QV-25261)
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)
Business Continuity Exercise WI (QV-44998)
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)
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 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) Vault Basics Product Lifecycle WI (QV-40521)
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)
Managed Change WI (QV-41399)
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) |
Managed Change Work Instruction (QV‑41399)
Services Project Change Management WI (QV‑02784)
GCP Project Assessment WI (QV-46341)
Project Incident Report Generation WI (QV-44762)
Vault Safety AIM Environment Management WI (PS-01146) |
| 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)
CDMS Vault Training Administration Work Instruction (QV-43779)
Veeva CDB Export Configuration Work Instruction (PS-01379)
Veeva CDB Data Ingestion Work Instruction (PS-01377)
Veeva CDB Custom Listing Programming Work Instruction (PS-01378)
Veeva CDB System Configuration Work Instruction (PS-01376) |
| SiteVault Services |
- |
- |
SV User Management WI (PS-00735)
SV Configuration Validation WI (PS-00736)
SV Change Management WI (PS-00737) |
| eCOA Services |
- |
ePRO Project Implementation Procedure (PS-01151) |
ePRO Change Management Work Instruction (PS-01158)
eCOA 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)
eCOA Study Conduct Work Instruction (PS-01156)
ePRO Study Design Work Instruction (PS-01153)
eCOA 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) |
| Quality Standards |
Audit Management (QV-27452)
Change & Configuration Management (QV-27364)
Computer Systems Validation (QV-27024)
Continuity and Availability Management (QV-28887)
Corrective and Preventive Action (QV-25308)
Incident and Problem Management (QV-28974)
Management Monitoring and Review (QV-27472)
Privacy Management (QV-31763)
Product Development (QV-31969)
Records Management (QV-27103)
Resource Management (QV-27276)
Risk Management (QV-27566)
Security Management (QV-31761)
Service Portfolio Management (QV-31190)
|
- |
- |
| Environmental Management System (EMS) |
Environmental Management Manual (SV-00001)
Emissions Reporting Policy (SV-00021)
EMS Continuous Improvement Policy (SV-00014)
Environmental Policy (SV-00002)
Sustainable Procurement Policy (SV-00020) |
Emissions Report Generation Procedure (SV-00024)
EMS Audit Management Procedure (SV-00004)
EMS Document Control Procedure (SV-00003)
EMS Non-conformance Procedure (SV-00006)
EMS Risk and Opportunity Management Procedure (SV-00007)
Environmental Initiatives Procedure (SV-00023)
Environmental Planning and Review Procedure (SV-00015)
Operations Control and Indicators Procedure (SV-00035)
Office Environmental Management Procedure (SV-00016)
Supplier Environmental Management Procedure (SV-00005) |
Carbon Footprint Calculation Work Instruction (SV-00028)
Environmental Aspects and Impacts Work Instruction (SV-00029)
Environmental Emergency Work Instruction (SV-00040)
Facilities Maintenance Work Instruction (SV-00038) |