Unclear validation plans
Validation requirements are complex, and mistakes can lead to delays, rework, and uncertainty about launch readiness .
Laboratory Readiness & Enablement
Launch and expand testing capabilities with confidence.
Scientific, regulatory, and operational expertise to help laboratories validate, implement, and operationalize new or expanded testing capabilities .
Where readiness breaks down
Three gaps that hold a new test back.
Many testing programs stall well before go-live. Validation, documentation and integration are usually the biggest barriers .
Missing SOPs
Without documented procedures, laboratories struggle to train staff, maintain consistency, and prepare for inspections .
Integration work no one owns
LIS and EHR interfaces stall between lab, IT and vendor. The test can't go live without them .
The outcome
What success looks like.
Readiness is achieved when the laboratory can move testing into routine operations with the documentation, workflows, and systems to support it.
- Validate new assays with confidence
- Launch new testing programs and move them into routine operations
- Establish inspection-ready documentation and regulatory readiness
- Connect laboratory systems and reporting workflows
- Build repeatable workflows your team can sustain
How we get you there
Building Blocks of Laboratory Readiness.
From planning and validation through go-live support, engagements can be tailored to where your laboratory is today .
01
Plan & Prepare
- On-site laboratory gap assessment
- Equipment, consumables & workflow guidance
- Validation planning
- SOP development
- Regulatory readiness
02
Build & Validate
- Validation execution support
- Verification support
- Report template design
- Validation documentation
- CAP / MolDX / NYS accreditation mapping
03
Connect & Go Live
- LIS / EHR integration
- HL7 / API connectivity
- Staff training
- Go-live support
- End-to-end testing & cutover support
The work in detail
Validation, documentation and integration.
Validation
- Study design & validation planning. Define study requirements, sample strategy, acceptance criteria, and the evidence needed to support clinical use.
- Reference standards & sample strategy. Identify appropriate controls, truth sets, clinical samples, replicates, and variant coverage.
- Run QC & analytical review. Review run quality, analytical performance, comparative results, and study evidence.
- CGW case review & reporting. Use validation cases to establish the interpretation and reporting workflow that will carry into clinical operations.
- Validation report & accreditation mapping. Document study results and supporting evidence, with mapping to relevant CAP, MolDX, or New York State requirements where applicable .
Validation studySample strategy by variant type
Documentation
- Procedural SOPs. Document laboratory workflows from sample handling through reporting.
- Workflow documentation. Translate testing processes, handoffs, responsibilities, and system touchpoints into usable operational documentation.
- Report templates. Establish reporting structures appropriate to the laboratory’s testing workflow.
- Training materials. Provide materials that support staff readiness and consistent routine operations.
- Readiness & gap documentation. Capture identified gaps, recommendations, and actions needed to support launch and inspection preparation.
Your documentation setOwned by your laboratory
Integration
- Interface planning & specifications. Define how clinical orders and results move between CGW and the laboratory’s systems.
- HL7 integration. Support interfaces connecting CGW with LIS and EHR systems .
- API integration. Support integration requirements where API-based connectivity is appropriate.
- Single sign-on. Support SAML-based authentication where scoped.
- Testing & cutover support. Support end-to-end interface testing and transition into routine operations.
Interface trafficOrders out, results back
Runs on PierianDx · Clinical Genomics Workspace
The workflow you validate is the one you run.
Validation and verification cases can be reviewed in CGW as laboratories establish the interpretation and reporting workflows they will use in clinical operations .
- Validation and verification in CGW. Use cases in the same environment that will support routine clinical interpretation and reporting.
- Carry the workflow into clinical operations. The interpretation and reporting workflow established during readiness becomes the foundation for routine use.
- Connect results to your systems. Integration Services can connect CGW with LIS or EHR workflows through approved interfaces .
| Gene | Variant | VAF | Tier |
|---|---|---|---|
| BRAF | p.V600E | 31% | I |
| TP53 | p.R273H | 44% | II |
| PIK3CA | p.E545K | 12% | II |
| ATM | p.L1420F | 48% | III |
Evidence changed since last review: 1Knowledgebase release 2026.10
What you receive
More than recommendations.
Depending on scope, engagements produce practical deliverables your laboratory can use through validation, launch, and routine operations.
Gap assessment report
Equipment, consumables & reagent list
Validation plan
Sample strategy
Validation report
Accreditation checklist mapping
SOP package
Report template
Workflow documentation
Integration specification
Training materials
Go-live plan
Planning a new or expanded testing program?
Whether you’re preparing for validation, addressing readiness gaps, or connecting laboratory systems, let’s talk about what it will take to move your program forward.
FAQ
Questions about laboratory readiness
What is included in laboratory readiness support?
Depending on scope, Laboratory Readiness & Enablement can include on-site gap assessments, equipment and workflow guidance, validation or verification support, SOP development, regulatory readiness, LIS/EHR integration, staff training, and go-live support. Services can support both new testing programs and laboratories expanding existing capabilities.
What’s the difference between validation and verification support?
Validation establishes the performance of a laboratory-developed or modified test for its intended clinical use. Verification confirms that an unmodified FDA-cleared or approved test performs as expected in your laboratory. Revalidation may be needed when changes to an existing test or workflow require the laboratory to demonstrate continued performance.
PierianDx can support the planning, execution, analysis, and documentation required for validation, verification, and revalidation projects.
Can PierianDx support LIS/EHR integration?
Yes. Integration Services can support connections between CGW and laboratory or clinical systems through HL7 interfaces, APIs, and SAML single sign-on where applicable . Support can also include interface specifications, end-to-end testing, and cutover support.
Can services support an existing lab adding a new assay?
Yes. Laboratory Readiness & Enablement supports both laboratories launching new testing programs and established laboratories adding assays, expanding test menus, or introducing new workflows. Depending on the need, support may include validation or verification, documentation, integration, training, and operational readiness.
Can we validate on the workflow we’ll run in production?
Yes. Laboratory Readiness & Enablement is offered alongside Clinical Genomics Workspace (CGW), so the cases you validate on are reviewed and reported in the same workflow you will use in routine operations . Our existing SOPs cover TSO500, TSO500 HT, TSO Comprehensive and TruSight Hereditary Cancer ; for other assays, we build the documentation with you .
What assays can you support us adding?
We are compatible with dozens of assays and pipelines and our team regularly onboards new ones . To see the full list and discuss onboarding your assay, contact us.