Veeva Qualification Package

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Diligent Pharma is an independent Quality and Compliance organization that qualifies clinical vendors on behalf of its Pharma and Biotech clients. After Diligent audits a vendor, we make their Qualification Package available to our entire client base through our technology platform instead of having to audit the same vendor multiple times per year.

Diligent Pharma has qualified Veeva through a rigorous, multi-day assessment led by expert auditors. The Veeva Qualification Package – the qualification audit report, audit agenda, and auditor’s credentials – is managed on the secure Diligent platform and is available for purchase by any client that needs to qualify the Veeva organization.

Recent Assessment Dates: August 2025

The following capabilities were assessed:

Core Capabilities

Computer Systems / 21 CFR Part 11 Compliance
Ethics/Anti-Bribery/Anti-Corruption
Facilities Management
Financial Stability
Insurance
Organization
Privacy & Personal Data Protection
Quality & Project Management
Risk Management
Staffing & Human Resources Management
Third-Party Quality Management & Oversight
Training

eClinical Technologies

CTMS
eCOA
eConsent
EDC/Clinical Database

eRegulatory Binders
eTMF
Investigator Site Budeting, Contracting & Payments
IRT/IxRS
MY Veeva for Patients
Opendata Clinical
Patient Feasibility, Recruitment & Retention
Site Connect
Sites & Patients
SIteVault
Study Training
Vault CRM
Veeva Commercial Cloud
Veeva Disclosures
Veeva Medical
Veeva Network
Veeva Promomats
Veeva Quality Suite
Veeva Regulatory Information Management
Veeva Safety Suite

Veeva Disclosures
Opendata Clinical
Investigator Site Budeting, Contracting & Payments
eTMF
Patient Feasibility, Recruitment & Retention
EDC/Clinical Database
Sites & Patients
MY Veeva for Patients
SIteVault
eRegulatory Binders
eConsent
eCOA
Veeva Safety Suite
Veeva Quality Suite
Veeva Commercial Cloud
Vault CRM
Veeva Network
Veeva Promomats
Veeva Medical
Veeva Regulatory Information Management

The Audit Report is an independent assessment that also includes the current status of Audit Observations and CAPA commitments (if applicable).

Frequently Asked Questions

1. I’m used to hiring a consultant auditor to conduct qualification audits. What if I want to stick with my process?

Diligent Pharma’s process is the same as hiring an independent consultant auditor. We see no reason to audit Veeva countless times per year on behalf of every client and waste their money.

ICH E6 (R3) leaves the qualification method up to Sponsors. Think of Diligent as an independent auditor that works on behalf of multiple Sponsors, simply allowing them all to use the results of a single audit and saving all parties valuable time and money in the process.

After your review of the audit report, Veeva will still support and answer any follow-up questions you may have to ensure the process is completed to your satisfaction.

2. In order to accept the audit report, I must qualify Diligent Pharma. Can I do that?

Yes. Diligent will provide you with a completed Core Qualification Questionnaire and enable access to any SOPs, Policies, or technical documentation you require immediately.

3. Why should I trust the quality of Diligent Pharma’s work?

The FDA has inspected Diligent Pharma’s clients many times and has reviewed their use of the Diligent Platform, deeming it a compliant way to qualify vendors.

Our company has been in business since 2017, and several of the largest pharmaceutical companies in the world – with some of the most stringent quality standards and expectations – are longtime clients. We are happy to provide client references upon request.

Each auditor has 10+ years of GxP auditing experience and appropriate technical expertise

Have more questions?

If you have any questions about our Veeva audit, please reach out to our team using our contact form:

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