Method Dev Sprint
A technical problem in your method? Solved in 3 to 6 weeks — with audit-ready documentation.
What Method Dev Sprint is
Method Dev Sprint is a surgical technical intervention: we diagnose the root cause of the analytical problem, run up to three tuning rounds against a success criterion agreed in advance, document the complete Standard Operating Procedure and deliver a technical report ready for an ISO 15189 audit or for answering an ANVISA deficiency letter. No padding — a working, documented method.
Audits
Inter-assay CV is above 10% and the ISO 15189 auditor has already flagged it as a non-conformity.
Deadlines
You received a formal ANVISA deficiency letter asking for LoD or cross-reactivity data. The response clock is already running.
Process
The protocol exists — but it lives in your senior scientist’s head. If they leave, the method goes with them.
Optimisation
You are about to start formal validation, but the method is not optimised yet. Redoing the validation later costs far more.
Do any of these sound familiar?
“Every week with a high CV is a week of questionable results for your customers. And a week closer to a serious non-conformity.“
What We Do
| ✓ Technical kickoff: review of the current method, historical data and root-cause hypotheses ✓ Experimentation plan with the success criterion defined before any assay is run ✓ Round 1: baseline and test of the main hypothesis ✓ Analysis and decision after each round: adjust, or lock the final protocol ✓ Tuning rounds 2 and 3 where needed, until the criterion is met ✓ Complete SOP written up: 14 sections, including quality controls and run validity criteria ✓ Handoff meeting with basic team training on the new protocol |
What you receive
| ✓ Approved experimentation plan, with the success criterion set in advance ✓ Run sheets for every run, with full traceability ✓ Standard Operating Procedure — signed PDF plus editable Word file ✓ Sprint technical report with the history of each round and the final protocol ✓ Baseline performance data (CV, estimated LoD) ready for Scientific Readiness or for audit ✓ Ongoing QC criteria — a one-page document for daily use |
A badly written or missing SOP is a time bomb in any audit. A good one is the proof that the laboratory controls what it does.
