CENTOGENE Qualification Package

Complete the form to request the package today, no payment required.

Rigorous and independent qualification assessment

Aligned with ICH E6(R3) requirements

Delivered to you in days

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Signant Health

CENTOGENE has partnered with Diligent Pharma to undergo a rigorous, independent qualification assessment led by an expert auditor. The resulting Qualification Package— including the audit report, agenda, auditor credentials, and more—is available through Diligent and can be requested via the above form. Upon approval from CENTOGENE, Diligent releases the qualification package to the requesting Sponsor and provides a 15-minute delivery meeting to ensure compliant usage. 

Diligent Pharma is an independent Quality and Compliance organization that qualifies clinical trial of Vendors on behalf of pharma and biotech companies. Through the Diligent qualification model, Vendor audits are performed once annually and produce a comprehensive audit report that Sponsors can use immediately for their qualification procedures in place of scheduling and conducting their own audit. When paired with necessary Sponsor review, this documentation is fully compliant with ICH E6(R3) requirements and allows Sponsors to qualify Vendors in days instead of months. 

Learn more about our model

What's included

Accepted globally by Health Authorities, the Diligent model – the secure use of centralized qualification data – allows Sponsors to quickly qualify and onboard CENTOGENE in days instead of having to wait months to secure a place on their audit calendar.

Recent Assessment Dates: March 2026

The following capabilities were assessed:

Core Capabilities

  • Computer Systems/21 CFR Part 11/Annex 11 Compliance

  • Ethics/Anti-Bribery/Anti-Corruption

  • Facilities Management

  • Financial Stability

  • Insurance

  • Organization

  • Privacy & Personal Data Protection

  • Quality Management System

  • Risk Management

  • Staffing & Human Resources Management

  • Third-Party Quality Management & Oversight

  • Training

Biomarker Lab

  • Cell Isolation

  • Chromatography & Mass Spectrometry

  • DNA Prep and Testing

  • Flow Cytometry

  • In Situ Hybridization Assays

  • Methods, Assay Validations (ELISA)

  • Next Generation Sequencing

  • qPCR Assays

  • Qualification

  • RNA Prep and Testing

  • Technology and Platforms

  • Tissue Biomarker Testing and Sample Capabilities

Core Capabilities

  • Computer Systems/21 CFR Part 11/Annex 11 Compliance

  • Ethics/Anti-Bribery/Anti-Corruption

  • Facilities Management

  • Financial Stability

  • Insurance

  • Organization

  • Privacy & Personal Data Protection

  • Quality Management System

  • Risk Management

  • Staffing & Human Resources Management

  • Third-Party Quality Management & Oversight

  • Training

Biomarker Lab

  • Cell Isolation

  • Chromatography & Mass Spectrometry

  • DNA Prep and Testing

  • Flow Cytometry

  • In Situ Hybridization Assays

  • Methods, Assay Validations (ELISA)

  • Next Generation Sequencing

  • qPCR Assays

  • Qualification

  • RNA Prep and Testing

  • Technology and Platforms

  • Tissue Biomarker Testing and Sample Capabilities

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

The 3-Step Compliance Process for Sponsors: Relying on a Third-Party Vendor Qualification Audit

To withstand a regulatory inspection, a Sponsor cannot simply download a report and check a box. You are outsourcing the data collection, not the decision-making. You must document active oversight through a structured 3-step process that satisfies both internal QMS requirements and external regulatory expectations (e.g., ICH E6(R3)).

01

Qualify the Source

Verify the third-party auditor’s GxP experience and qualifications. Confirm the audit was conducted against the required regulatory guidelines.

02

Gap-Assess the Report

Check recency, scope coverage, and CAPA status against sponsor-specific systems and services. Close any gaps with a supplemental questionnaire or targeted review.

03

Accept & Retain Ownership

Sponsor QA formally documents the review and acceptance (i.e. by creating a cover page to be stored with the report), and confirms the sponsor retains GxP accountability.

Frequently asked questions

If the vendor referred me to Diligent to access this report instead of hosting our own audit, is that compliant?

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

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

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

Do I need a Diligent subscription to access the report?

Have more questions?

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

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