Validation Evidence Readiness
Score your lab in ten questions.
The maturity model has four levels. Most analytical labs land at Level 2: a system tracks tasks and approvals, but the numbers are still keyed by hand. Answer honestly and you get a level, a breakdown across five dimensions, and a scorecard you can share with QA and IT.
- About five minutes. No right answers, only accurate ones.
- Scored in your browser. Nothing is sent until you ask for the scorecard.
Level 4: Continuously submission-ready
- Report cycle
- Hours
- Rework
- Under 5% (right-first-time above 95%)
- Data capture
- Evidence assembled at point of capture
- Audit readiness
- Zero preparation
Level 3: Data integrated
- Report cycle
- 3 to 10 days
- Rework
- Under 15% of reports
- Data capture
- Instrument data flows in, worksheets pre-populate
- Audit readiness
- Days of preparation
Level 2: Workflow digitised
- Report cycle
- 10 to 20 days
- Rework
- 15 to 30% of reports
- Data capture
- System for tasks and approvals, numbers keyed by hand
- Audit readiness
- Weeks of preparation
Level 1: Paper dependent
- Report cycle
- More than 20 days
- Rework
- More than 30% of reports
- Data capture
- Fully manual
- Audit readiness
- Assembled when an audit is announced
The standard
What readiness means
Level 4 is defined by four criteria. They describe an outcome, not a product.
- 01
No manual transcription
Instrument results reach worksheets and reports without a person retyping them.
- 02
Evidence assembled at point of capture
Each result is filed against its parameter and protocol the moment it is generated.
- 03
ICH Q2(R2) traceability by default
Every acceptance criterion links back to the protocol, and forward to the result, without manual cross-referencing.
- 04
Audit-ready without preparation
The complete evidence set can be presented on demand, with a full audit trail and e-signatures.