Writing LIMS requirements is where successful implementations begin—and where troubled ones get their first cracks. We've reviewed hundreds of requirements documents, and the difference between projects that sail through and those that struggle almost always traces back to how well requirements were defined upfront.
Key Finding: Labs that invest 4-6 weeks in thorough requirements gathering typically save months during implementation. The ROI on this upfront work is enormous.
Why Bad Requirements Lead to Bad Outcomes
- Vague requirements let vendors say "yes, we do that" to everything, then deliver something that technically meets the requirement but not your actual need.
- Missing requirements become surprise scope additions mid-project—expensive, disruptive, and avoidable.
- Over-specified requirements eliminate good solutions and lock you into approaches that become obsolete.
- Untestable requirements can't be verified during acceptance testing, leading to disputes.
The Requirements Framework
1. Business Requirements
Describe what your lab needs to accomplish at a high level—the "why" behind everything else:
- • The lab must process 2,000 samples per day with current staffing
- • Results must be delivered to physicians within 24 hours of sample receipt
- • The system must support CAP and CLIA compliance
- • Billing must achieve clean claim rates above 95%
2. Functional Requirements
Describe what the system must do—specific capabilities and behaviors. Good functional requirements are:
- Specific: Not "handle samples efficiently" but "assign unique accession numbers automatically upon sample receipt"
- Measurable: Include quantities, timeframes, or thresholds
- Testable: You can verify whether the system does this or not
- Necessary: Connected to a real business need
Example:
REQ-F-042: The system shall allow users to create custom report templates using a drag-and-drop interface without requiring programming knowledge.
3. Technical Requirements
Infrastructure
- • Deployment model (cloud, on-premise, hybrid)
- • Database platform preferences
- • Hosting and redundancy
- • Backup and disaster recovery
4. Compliance Requirements
For regulated labs, compliance requirements deserve special attention:
- • CLIA (if applicable)
- • CAP (if accredited)
- • State regulations
- • 21 CFR Part 11 (if FDA-regulated)
- • HIPAA
- • ISO 15189 (if certified)
Important: Compliance requirements should reference specific regulations, not just say "must be compliant." Vendors interpret "HIPAA compliant" very differently.
The Requirements Writing Process
Step 1: Gather Input Broadly
Talk to everyone who will use or be affected by the LIMS:
Lab Staff
Daily users
Supervisors
Workflow managers
Quality Team
Compliance
IT
Infrastructure
Client Services
Customer interaction
Finance
Billing
Step 2: Prioritize Ruthlessly
| Priority | Definition |
|---|---|
| Must Have | Non-negotiable. Without this, the system fails to meet fundamental needs. |
| Should Have | Important but not absolute. You'd make significant tradeoffs. |
| Could Have | Valuable additions if they don't compromise more important requirements. |
| Won't Have | Explicitly out of scope for this project. Prevents scope creep. |
Reality Check: If more than 30% of your requirements are "Must Have," you haven't prioritized hard enough. Be ruthless.