TemplateUpdated Jan 2026
LIMS Requirements Template
100+ functional and technical requirements. Get clarity on what matters before you talk to vendors.
How to Use This Template
1
Gather Stakeholders
Include lab ops, IT, quality, billing, and end users
2
Rate Each Requirement
M = Must Have, S = Should Have, C = Could Have, W = Won't Have
3
Add Your Specifics
Template gives categories; you add details for your lab
4
Validate Before Sending
Review with stakeholders before sending to vendors
Section 1: Functional Requirements
Sample Management
Unique accession numbersM/S/C/W
Barcode/RFID labelingM/S/C/W
Sample status trackingM/S/C/W
Aliquoting supportM/S/C/W
Storage location trackingM/S/C/W
Chain of custodyM/S/C/W
Retention/disposal rulesM/S/C/W
Test Management
Custom test panelsM/S/C/W
Reflex testing rulesM/S/C/W
Test-specific TAT targetsM/S/C/W
Calculated results/formulasM/S/C/W
Reference ranges by demographicsM/S/C/W
Critical value flaggingM/S/C/W
Results & Reporting
Customizable report templatesM/S/C/W
Auto-verification rulesM/S/C/W
Multi-channel delivery (fax, HL7, portal)M/S/C/W
Electronic signaturesM/S/C/W
PDF archivingM/S/C/W
Critical value notificationM/S/C/W
Section 2: Integration Requirements
Instrument Integration
Bidirectional interfaces
Existing drivers for your instruments
ASTM protocol support
Worklist queuing to instruments
Healthcare Systems
HL7 v2.x messaging
FHIR APIs
EHR integration (specify your EHR)
Reference lab connections
Section 3: Compliance & Quality
Regulatory Compliance
21 CFR Part 11 compliant
CLIA requirements
CAP inspection ready
HIPAA-compliant data handling
Validation documentation package
Complete audit trail
Tamper-proof timestamps
QC with Westgard rules
Levey-Jennings charts
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