Veeva Qualification Package
Qualify Veeva today, no payment required.
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 can be shared with any Sponsor at no cost.
Accepted globally by Health Authorities, the Diligent model – the secure use of centralized qualification data – allows Sponsors to quickly qualify and onboard Veeva in days instead of having to wait months to secure a place on their audit calendar.
Recent Assessment Dates: February 2024
The following capabilities were 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 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 the details below:
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