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Veeva Systems & Diligent Pharma Partner to Streamline Vendor Qualification and Compliance

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Veeva Systems

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 Vault 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.

Assessment Dates: February 27-28th, 2024

The following capabilities are assessed:

Veeva Vault

  • Company Organization
    • Company History and Background
    • Company Size
    • Scope of Operations
    • Area of Expertise
  • Software as a Service
  • Financial Stability
  • Insurance
  • Ethics/Anti-Bribery/Anti-Corruption
  • Privacy & Personal Data Protection
  • Facilities Management
    • Physical Location and Condition
    • Facility Access & Control
    • Physical Protection Systems
    • Business Continuity
  • Electronic/ CSV / 21 CFR Part 11 Compliance
    • Systems Used
    • Server Location, Configuration, and Access
    • Systems Alarms and Firewall Protection Approach
    • System Backup and Recovery

 

  • QMS, Quality Control, and Quality Assurance
    • QMS Elements
    • Accreditations and Certifications
    • Quality Assurance Responsibilities
    • Regulatory Inspection History
  • Risk-Based Quality Management
  • Third-Party Quality Management and Oversight
  • Document Management and Control
  • Staffing and Human Resource Management
  • Training
  • Operations and Project Management
  • TMF/e-TMF
  • Release Management
  • Change Management

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, eConsent, and IxRS), which are now available for purchase on the Diligent Qualification Platform.

Client request

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.

Veeva Systems

  • Terms of use:

    These terms of use apply to the purchase and download of the Veeva VQA Report, as well as to the access of the RFI. The person checking that they “agree to the terms of use” represents that they have the authority to act on behalf of, and to bind the named Purchasing Organization (“Purchaser”) to these terms of use.

    The Purchaser agrees that they will download and use the VQA Report (and/or RFI) for the Purchaser’s internal business purposes only and will maintain the VQA Report (and/or RFI) as confidential and not disclose them to any third parties.

    The Purchaser may not distribute or permit copies of the VQA Report or RFI to be used for any other purpose.

  • This field is for validation purposes and should be left unchanged.

Questions?

Diligent Client Support:
Peter Haessig
Director, Client Partnerships
Diligent Pharma, Inc.
179 Nassau Street, Suite 3A,
Princeton, NJ 08542
E: peter.haessig@diligentpharma.com
T: +1 973-713-8242