LIMS – The Regulatory Assistant?

What’s a Biobank?
Easy – a collection of data and samples.

And what is a biobank’s core function?
Managing those samples and compiling that data (depending on the biorepository’s focus, of course).

More Samples…and Data
Over the last decade, biobanks have grown larger and increasingly more complex. Today’s biobank may contain several thousand or even millions of samples.

As an example of the massive increases in samples biobanks face, reported last year that

Biobank Graz of the Medical University of Graz, Austria has over 19 million samples, while the International Agency For Research On Cancer (IARC) Biobank (IBB) contains over 5 million biological samples from over 560,000 individuals.

Biobank services are likewise on the rise. The Shanghai Outdo Biotech biobank offers “high-throughput genomics, transcriptomics, proteomics and other one-stop research platforms on site. The aim is to convert R&D into products quickly.

Increasing Regulatory Pressures on Biobanking
The increasing complexity of biobanking – whether due to the volume of samples or data stored, growing sample requests or other services offered by the biobank – invariably includes regulatory compliance concerns.

In addition to meeting industry standards such as those established by ISBER, biobanks face a dense patchwork of compliance challenges. These include ethics committees, IRBs, scientific boards, the European legal framework, Material Transfer Agreements, HIPAA, GDPR, and numerous other compliance requirements.

Maintaining compliance with complex regulations demands exhaustive data solutions that manage every aspect of the biobanking operation. Some examples include:

  • Study Management: Define and manage studies to ensure compliance with protocols.
  • Requisition & Distribution: Retrieve samples from storage and package them for distribution.
  • Genealogy: Track and maintain genealogy of aliquots, derivative and pooled samples.
  • Inventory Management: Manage sample inventory, and quickly locate samples.
  • Patient Consent Tracking: Track consent restrictions to meet ethical and legal requirements.
  • Chain of Custody: Maintain a complete chain of custody, logging all actions taken on a sample.
  • Biospecimen Annotation: Annotate specimens with clinical and quality information.
  • Collection Kits: Manage the inventory of tools and kits required to collect samples.
  • Data Security and Compliance: Restrict unauthorized access to patient data and comply with the latest regulatory requirements.

Find Samples & Data Quickly – in Full Compliance
Fast sample and data acquisition speeds are vital. As one explorative survey found: “the effective and efficient use of biobank resources depends on their accessibility.” Compliance with the relevant industry regulatory guidance is also critical.

LabVantage LIMSHistorically, acquisition speeds and compliance have been seen as somewhat at odds as adherence to regulatory frameworks has tended to slow down operational processes.

Purpose-Built Biobanking LIMS
The solution – and this isn’t a big secret – is to use task-and industry-specific workflows.

What are the benefits of purpose-built LIMS for industries such as biobanking? Faster, smoother implementations & startups, plug-and-play industry-specific compliance and generally fewer unwanted (by both the client and LabVantage) surprises.

This translates into three key results every LIMS buyer wants to see:

1.       Faster, easier implementations

2.       Better lab productivity and throughput

3.       Improved regulatory compliance

These benefits enable companies to innovate faster in the R&D cycle, run labs more efficiently, improve manufactured product quality, achieve accurate recordkeeping and comply with complex, evolving regulatory requirements.

LIMS Designed With Experience
The ultimate configurability of the LabVantage platform has always made it a top choice. Our experience working with the biobanking industry, performing implementations, and keeping apace of the latest industry guidance enabled us to develop a purpose-built LIMS solution. LabVantage Biobanking is the direct result of that collective knowledge and familiarity with biorepository needs.

Learn more about LabVantage Biobanking.