Validation Services
NGS Validation Package
– Expert Support for Your Lab
Get your lab NGS-ready with our comprehensive Validation Package, designed for labs with limited experience, staff, or analytical expertise. Our modular approach ensures tailored support for your lab’s needs.
1. Accreditation Will Expose Weak Assumptions
Assessors don’t care that your assay “works in practice.” They care about documented evidence, traceability, and defensible decisions. Validation gaps get found fast and fixing them after assessment is expensive.
2. NGS Failure Modes Are Not Obvious
NGS doesn’t fail loudly. It fails silently coverage bias, pipeline misconfiguration, poor QC thresholds, or incorrect variant filtering. Without structured validation, you won’t know what you’re missing until it’s too late.
3. Internal Teams Are Already Stretched
Most labs underestimate the time, expertise, and coordination required for end-to-end validation. This package prevents validation from becoming a six-month distraction that stalls go-live timelines.
4. You Need Evidence You Can Defend
Validation isn’t about generating data. It’s about generating defensible conclusions. We help you prove performance, define limitations, and document decisions in a way that stands up to scrutiny.
Module 1 - Consultancy Support
- Accreditation consultancy
- Guidance on NATA requirements, bioinformatic pipelines, project management, and planning
- Estimated Time: From 6 hours of face-to-face consultation (including documentation & evaluation)
- Deliverables: Comprehensive Accreditation Plan
Module 2 - Wet Lab Validation Support
- Preparation of samples (from extracted DNA), libraries, QC, sequencing
- Full report for up to 96 samples
- Options for automated or manual preparation
- Training session for your team to run samples and generate additional validation data
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Estimated Time: From 2 weeks (including documentation & evaluation)
Breaks into phases requiring initial input from your team
Module 3 - Dry Lab Validation Support
- Process raw sequencing data or VCF/BAM files
- Establish secondary analysis pipeline if needed (in collaboration with Franklin)
- Initial high-level analysis to check concordance and troubleshoot issues
- Team training session to run cases and generate additional validation data
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Estimated Time: From 2 weeks (including documentation & evaluation)
Phased approach requiring starting data from your team
Proud Partnerships
How does it work?
Initiation
You reach out to Decode Science with your preferred module selection
Assessment Phase
Decode team assess your clinical needs
Support Plan Prep
Decode team builds a validation support plan
We Work Together
We work with you to implement the plan. Work with you to prepare for validation.
we’re here to all your questions
How much internal time will our team need to commit?
More than zero — less than doing it alone. Expect defined input points (samples, data, decisions), but not weeks of unfocused effort. If your team can’t commit any time, validation will fail regardless of vendor.
Will this satisfy accreditation requirements?
We align validation activities to accreditation expectations (e.g. NATA), but we don’t “guarantee” accreditation. Anyone who does is lying. What we do guarantee is that your validation is structured, documented, and assessor-ready.
Can this be used for new assays or platform upgrades?
Yes. The framework applies to new panels, new instruments, chemistry changes, pipeline updates, and assay expansions. If performance characteristics change, validation is not optional.
Will our staff actually learn or just watch?
They will learn. Each module includes hands-on training so your team can independently generate additional validation data after we step away. If knowledge transfer doesn’t happen, the engagement has failed.
What happens after validation is complete?
You retain all documentation, workflows, and training outputs. No vendor lock-in. If assessors raise questions later, you’ll have the evidence to respond — without scrambling.
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