The Scale-up Series: How clinical diagnostic labs can automate regulatory compliance


QIAGEN Digital Insights

The Scale-up Series: How clinical diagnostic labs can automate regulatory compliance

Part 2: Why regulatory compliance is more important than ever for clinical labs 

Clinical labs are under growing pressure to manage increasing test volumes and more complex diagnostic assays, while at the same time facing budget cuts and a continuously evolving regulatory landscape. To thrive in this challenging environment, clinical labs are focusing their efforts in niche areas that give them a competitive edge. For many, this means automating and outsourcing regulatory and compliance management.


Survival of the fittest

Even though the regulations have been in place for many years, the interpretation of those regulations changes over time. Sometimes the changes occur because of technology enhancements in the industry. Other changes can be related to an evolving understanding of the regulatory process. Still others may be related to the clinical utilization of laboratory information.

Bioinformatics platforms with compliance capabilities and features built-in can truly improve lab productivity and better prepare clinical labs to survive and even thrive in an uncertain regulatory future.

Next up in our four-part blog series for clinical diagnostic labs, we discuss how clinical labs can scale security, regulatory, and compliance management.


Challenge #2: The ever-changing regulatory landscape

Every clinical diagnostics company contends with growing—and increasingly complex—regulatory, certification, and security requirements. When a company expands to new countries, the task becomes tougher still, especially if this brings new requirements around data sovereignty and intellectual property (IP) protection. In these conditions, do-it-yourself compliance solutions quickly become too expensive and complex to maintain.


Solution: Mitigate risk by offloading security and compliance processes

In lieu of hiring staff to continually monitor the ever-changing regulatory landscape, work with a vendor that has a proven track record of helping clinical diagnostic labs succeed by building solutions that meet the industry’s most strict compliance regulations, including:

  • 21 CFR § 11
  • GDPR
  • IVDR
  • End-to-end encryption
  • Strict production system access control
  • Audit trail
HIPAA, CLIA and regulatory readiness: How your lab can always be ready

For clinical diagnostic labs, a platform-as-a-service combined with scalable informatics solutions can maximize compliance, increase efficiencies, and decrease risk.

DNAnexus®, developer of the world’s most secure, trusted platform for biomedical data analysis, and QIAGEN Digital Insights, owner of the world’s largest, fastest growing genomic knowledge base, are partnering to provide clinical diagnostic labs an agnostic, end-to-end workflow for oncology and hereditary disease applications that goes from FASTQ to final report in a fraction of the time and cost.

Specifically for regulatory and compliance management, DNAnexus Titan™ removes bottlenecks in development and production with a unified platform that brings all your data and pipelines together in one place to deliver unparalleled efficiencies. The DNAnexus team manages industry and region-specific security and compliance requirements for you, enabling you to meet the growing global demand for NGS testing.

The purpose-built DNAnexus Titan platform complies with current and future security, quality, and compliance requirements as they evolve over time, including ISO27001, NIST 800 framework, HIPAA, GDPR, GxP/ICH regulations, CAP/CLIA, and more. The platform even provides compliance with data transfer requirements as you sample genomes throughout the world, including regions in Europe and Asia.


On-demand webinar with DNAnexus

Want to learn more? Watch our on-demand webinar with DNAnexus, where we present an ultra-fast workflow for comprehensive genomic profiling.

  • Learn how to create, refine, validate, and execute NGS analysis and interpretation pipelines in QCI Secondary Analysis, our cloud-based service for NGS secondary analysis, and QCI Interpret—our clinical decision support software that is preconfigured for the Illumina® TruSight™ Oncology 500 assay.
  • Learn how DNAnexus—the world’s most secure, trusted platform for biomedical data analysis—simplifies compliance management and minimizes the need for expensive hardware, additional IT resources, and advanced bioinformatics skills.
  • Receive a virtual demonstration of how to analyze an entire sequencing run in 5 easy steps using this workflow.

PREVIOUS POST: “Part 1: Overcoming NGS data analysis challenges of high-throughput sequencing”


UP NEXT ⇒ The third blog in our Scale-up Series will discuss how clinical diagnostic labs can reduce operational costs.

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