TEAM
JAPAN
USA
EUROPE
PROBLEM
The deadline for the IVDR transition period (although extended) is approaching fast. To compound the problem notified bodies are moving slowing and have a large backlog. Get in front our your competition with an early submission and approval.
Disruption of the daily routine workload can cripple you lab. Not to mention the deluge of work that came along with covid. How are you going to get the job done with the limited time you have.
Meeting IVDR is easy when you start from zero. However you do not have that luxury. Legacy processes developed over many years cannot be scrapped. Being able to retroactively meet regulation requires a deep understanding and experience of lab processes.
In order to meet regulatory requirements, software development best practices must be implemented. This requires experienced and talented software engineers who are expensive and hard to find.
USERS
SOLUTION
karilian will create process and tooling
changes to process and deployment not to your core algorithms
create documentation to communicate to regulators + team members
use the pipeline you currently have in routine
ensure the lab software can run anywhere + anytime at scale
minimize regulator hindrence on development within the lab
SOLUTION
ensure software issues are reported and fixed
track development of bug fixes or new features
ensure the relevant users are informed and updated
ensure decision makers have insight into software features and design
robust testing of upgrades, bug fixes or feature enhancements
no negative effect on performance results
SOLUTION
removal of manual steps from repetitive processes
the best results for all patients at a high quality level
same results after a bug-fix, enhancement or update
software that can survive supply chain attacks or malicious updates
allow manual changes to be accessed for R&D and debugging.
SOLUTION
creation and execution of test plans
testing and simulation with available datasets, artificial DNA
of assay performance to stakeholders
utilise alternate compute infrastructure
don't perturbe the daily routine of the laboratory
obtain the best results for patients over time
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