Kapadi Qualification Package

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Kapadi
Kapadi

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 Kapadi through a rigorous, multi-day assessment led by expert auditors. The Kapadi 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 Kapadi in days instead of having to wait months to secure a place on their audit calendar.

Primary CRO Package

Recent Assessment Dates: 12-28 May 2025

The following capabilities were assessed:

Core Capabilities

  • Certifications 

  • Computer Systems/21 CFR Part 11 Compliance

  • Data Management & Transfer

  • Ethics/Anti-Bribery/Anti-Corruption

  • Facilities Management

  • Financial Stability

  • Insurance

  • Organization

  • Privacy & Personal Data Protection

  • Quality & Project Management (QMS)

  • Risk Management

  • Staffing and Human Resource Management

  • Third-Party Quality Management and Oversight

  • Training

Clinical Services

  • Biostatistics

  • Centralized Data Management

  • Clinical Monitoring

  • CRO Project Management

  • Data Management

  • Investigator Site Budget Contracts

  • Medical Writing

  • Patient Recruitment & Retention

  • Pharmacovigilance

  • TMF/eTMF

Pop-Up Sites Package

Recent Assessment Dates: 03-04 September, 04 November 2025

The following capabilities were assessed:

Clinical Services

  • Biostatistics

  • Centralized Data Management

  • Clinical Monitoring

  • CRO Project Management

  • Data Management

  • Investigator Site Budget Contracts

  • Medical Writing

  • Patient Recruitment & Retention

  • Pharmacovigilance

  • TMF/eTMF

Pop-Up Clinical Investigator Sites:

  • Essential Records

  • Investigator Privacy and Eligibility Consent Form

  • Participation

  • Patient Matching

  • Preparing a Local Site for Pop-Up Site

  • Supporting Computer Systems

  • Translations

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 Kapadi 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 an d saving all parties valuable time and money in the process.

After your review of the audit report, Kapadi 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 Kapadi audit, please reach out to our team using our contact form:

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