Challenges
- CENTOGENE, a data-driven rare disease company, supports clients globally from its diagnostic laboratory in Rostock, Germany.
- Clients must verify CENTOGENE’s compliance with health regulations and confirm its biomarker laboratory and genetic testing capabilities meet industry expectations. This occurs through an extensive process involving qualification questionnaires (RFIs) and an onsite audit.
- These audits are redundant and costly, requiring numerous interviews with CENTOGENE’s subject matter experts and can cause a complete shutdown of the laboratory for two days. This results in a cost of $35,000 per audit, due to employee time and lost productivity.
- As a result, clients sometimes had to wait over 3 months to secure an audit date due to CENTOGENE’s large client base and limited availability to host these costly audits. This could potentially slow deal closures for clients needing quick qualifications.
Solution: Proactive Qualification with Diligent Pharma
- Through an independent auditor, Diligent Pharma conducted a comprehensive onsite qualification audit of CENTOGENE, thoroughly assessing its complete suite of capabilities and services.
- CENTOGENE’s Qualification Package—comprising of the audit report, observations, CAPA responses, and completed RFIs— was hosted on the Diligent Platform.
- Now, every new client first accesses CENTOGENE’s Qualification Package on the Diligent Platform instead of conducting their own, redundant audit.
- After reviewing the package, clients can still ask CENTOGENE specific follow-up questions and review SOPs to complete the qualification to their specific satisfaction.
Results
- 90% Reduction in Audit Burden: Joining Diligent Pharma has eliminated 90% of the audits CENTOGENE typically hosts in a year.
- Over $300,000 in Cost Avoidance: CENTOGENE has substantially reduced costs associated with employee time and lost productivity for each audit.
- Elimination of 3-Month Delays: Clients can now qualify CENTOGENE within days by accessing its comprehensive Qualification Package on the Diligent Platform, accelerating deal closures and strengthening client relationships.
- Maintaining Flexibility: Despite the streamlined qualification process, CENTOGENE’s approach remains flexible to meet clients’ unique needs. Clients can still ask specific follow-up questions and request tailored information, ensuring the qualification process meets their exact requirements and supports their specific goals.
Give Your Team Back the Time They Deserve. Are You Ready to Reduce Your Audit Burden?
Discover how the Diligent Platform can streamline your qualification process, eliminating the costly and redundant effort involved in every client qualification.