Diligent Pharma is an independent and accredited quality and risk management organization that helps Pharma/Biotech and CRO organizations increase quality and mitigate risk in vendor qualification and selection.
Veeva Systems and Diligent Pharma have partnered together to help organizations save time when qualifying and onboarding Veeva as an approved GxP service provider by maintaining an up-to-date Vendor Qualification Audit report (VQA) and Qualification Questionnaire (RFI) documents for purchase on the Diligent Qualification Platform.
What are Diligent Pharma’s Qualification Audit Standards?
A Diligent Qualification Audit is a rigorous assessment that adheres to all Global Regulatory guidance and follows the qualification standards as defined by an advisory board of biopharmaceutical and Contract Research Organizations through the Avoca Quality Consortium. The standards are defined by health regulations or guidance documents, extrapolated based on regulations and guidance, or have become expected requirements based on leading industry practices.
Veeva’s Qualification Audit report enables organizations to confirm Veeva has the capability, infrastructure, and processes to provide its software services to an appropriate standard in line with applicable regulatory requirements and GxP guidance. The audit report is a comprehensive assessment of the Veeva Organization and Veeva Applications, and focuses on Veeva’s Quality Management Framework, software development and testing processes, computer system validation, hosting architecture, information security, and change management practices – applicable to all Veeva Vault applications.
Report Published: January 19th, 2023
The following capabilities are assessed:
- Financial Stability
- Privacy & Personal Data Protection
- Facilities Management
- IT Systems/Architecture
- Electronic/Computer Systems Validation /21 CFR Part 11 compliance
- Computer Systems Validation
- Disaster Recovery
- Disaster Recovery – Vault
- Quality Management System, Quality Control and Quality Assurance
- Risk-Based Quality Management
- Third-Party Quality Management and Oversight
- Document Management and Control
- Information Security
- Staffing and Human Resource Management
- Personnel Training Records
- Project Management
- Change Management
- Product Support
Clinical Monitoring Capabilities
- Organization and Contents (TMO)
- Security and Control (TMC)
- Quality Control (TMQ)
- Access (TMA)
- Verification/Validation (TMV)
- Permissions (TMP)
- Document Management (TMD)
- Archival/Storage/Retention (TMS)
- Indexing and Metadata (TMM)
- Reports (TMR)
- Scanning/Transfers/Integration (TMI)
The Audit Report is an independent and comprehensive assessment that also includes the current status of CAPA commitments (if applicable) and the auditor’s CV.
Organizations can quickly prequalify or requalify Veeva by obtaining the Audit Report and RFI documents (Core & eTMF), which are now available for purchase on the Diligent Qualification Platform.
1. Complete the form below. No payment is needed at this stage.
2. Your request will be approved by Veeva Systems. On approval you will be emailed a secure link to purchase the Qualification Audit report and RFI documents and download a pdf copy of your invoice.
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