Quality, compliance and support

Ensure the quality of your results and your regulatory compliance

We help you with regulatory compliance, offer methodologies to validate changes in your laboratory’s process and provide process quality control tools. Once you are up-and-running, our world-class support staff assists your  team with their day-to-day activities.

Laboratory regulatory compliance

Obtaining regulatory compliance is a necessary but increasingly complex part of any laboratory’s operations. SeqOne provides tools and support that make it easier to obtain and maintain these certifications.

  • By choosing SeqOne, you will leverage a platform that is both CE-IVD and ISO13485 compliant
  • The security of your data will be guaranteed by our platform hosted on ISO 27001 (HDS) compliant infrastructure
  • To keep up with the latest bioinformatic developments, pipelines are regularly updated with the criteria provided to customers in the form of a report
  • The platform logs all actions performed by users to ensure complete traceability, which is an essential requirement for certification
  • Regular training sessions ensure that your team always has the information they need, to get the most out of the platform
  • SeqOne’s team can participate in feedback discussions to address technical questions related to the platform and bioinformatics 

SeqOne can provide documents that outline many of the certification requirements, which simplifies your team’s tasks and accelerates the certification process.

Laboratory process validation

Laboratories often have to alter their processes in order to reflect the changing requirements and new technologies. Each modification requires re-validation of the process to ensure that results continue to meet expectations. SeqOne has a complete laboratory process validation program consisting of four key steps:

  1. Validation planning assistance
  2. Support in wetlab design and specification
  3. Sequencing run data analysis complete with wetlab design-optimisation recommendations 
  4. Final validation report of the new method

Design validation and the wetlab supplier

Laboratory process validation involves a comprehensive evaluation of the analysis and interpretation process. This evaluation encompasses kit design, sample preparation operations (wetlab), sequencing, analysis and interpretation tools. SeqOne routinely provides detailed feedback to our customer’s wetlab supplier so that the panel design is optimized. SeqOne has experience working with most major wetlab providers in this way.

Process and sample quality control

Process quality control involves systematic verification of each sample to ensure that it meets the minimum quality standards. To assist your team with this, we have developed several tools:

  • File integrity checks to ensure that files are not corrupted during the upload.
  • Identity tracking using genotyping, to verify that each sample matches the right patient.
  • Coverage verification by run and by sample, including detailed base-by-base coverage checks.
  • Detailed quality report for each sample.
  • Logging of all user actions related to each sample, to ensure traceability.

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Clinical-grade support

We view support as a key factor in ensuring your patients get the best care. Your team should be able to concentrate on important patient matters, without having to resolve issues related to the tools they use. For this reason, SeqOne has hired support staff consisting of qualified biologists, bioinformaticians and IT specialists who understand your team’s environment and can provide speedy and relevant answers.

GDPR

We take the confidentiality of both your patient’s and your institution’s data very seriously. All data is kept in secure ISO 27001 (HDS) infrastructure within Europe, in compliance with the GDPR requirements. Furthermore, SeqOne provides contractual guarantees that we will comply with your requirements with regards to data confidentiality.

They trust us

  • It’s very nice to work with SeqOne, I’d never go back to the way I was working before. I have more confidence in the accuracy of my diagnoses and can deliver them much faster.

    Anne-Sophie Lebre

    CHU Reims, France

  • SeqOne is always available to listen and help solve my issues, collaborating with us to deliver practical solutions. This makes SeqOne, in my experience, the best bioinformatic solution on the market.

    Jean-Marc Rey

    CHU Montpellier, France

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