Method validation planning, analysis and reporting.
I help laboratories plan the required studies, assess their data and prepare a traceable validation report. Your team performs the bench work and retains responsibility for review and approval.
Remote support in English or Swedish. Fixed-scope packages from €900 per method, excluding VAT, quoted in writing after a free thirty-minute call.
- From €900 per method, ex VAT
- Remote · English or Swedish
- ISO 15189 · CLSI · ICH M10
- Scope and price in writing before it starts
4 causes
Where validations lose time
Most method validations take longer than they need to, and the delay rarely comes from the instrument. It comes from four places, and all four are decided before the first injection.
- Studies run one at a time
Precision, trueness and linearity run as separate experiments when one well-designed set of runs would have covered all three.
- Gaps found late
A stability or carry-over study nobody planned surfaces at review, or at the assessment, and the work goes back to the bench.
- Statistics nobody can walk through
The calculations live in an inherited workbook that nobody can explain line by line when asked.
- One busy person
The person who knows the statistics is also the busiest person in the laboratory, so the validation waits.
All four are cheaper to fix in the plan than on the bench, which is why the plan is the first deliverable in every package that starts from scratch.
5 documents
What you get
Documents written in your templates and your version scheme, that your laboratory can defend at assessment without me in the room.
- Validation plan
The studies the method needs for its intended use under the guideline you follow, which runs can be combined, how many samples, and the acceptance criteria, written and approved by you before anything is run.
- Gap check
Your existing data read against that plan, with a list of exactly what is missing before anyone goes back to the bench.
- Statistical analysis
Precision, trueness, linearity, limits of detection and quantification, method comparison, matrix effects, carry-over and stability, each with its graphs and a pass or fail against your own criteria.
- Validation report
Traceable from the raw data to the conclusion, prepared for review and sign-off by your laboratory director.
- Workbooks
The calculation workbooks behind the report, delivered for your continued use, so the next verification starts from a working base.
If the method is going into routine, the risk assessment that takes it there is written alongside the report: included in the full-support package, and added to the others on request. Say so on the call and it goes into the quote.
4 packages
Packages and prices
Fixed price per method, in euros and excluding VAT, confirmed in writing after a free thirty-minute call.
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€900
Plan and gap check
5 working days
A validation plan for one method under the guideline you follow: the studies the method needs for its intended use, how runs can be combined, how many samples, and the acceptance criteria. Plus a gap check of any data you already have, read against that plan. One round of revisions after your review is included.
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€2,800
Analysis and report
10 working days
Statistics, graphs and a traceable validation report from your raw data, against an approved validation plan: your own, or one written under the package above. One round of revisions after your review is included.
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€4,500
Full validation support
Project-based
Plan, gap check, analysis and report run as one project, with questions answered while your team runs the experiments, one round of revisions after your review and another after the assessor’s, and the risk assessment that takes the method into routine, included rather than quoted.
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€900 / month
Ongoing verifications
Monthly
Recurring lot-to-lot, instrument-comparison and annual verifications, run on the same workbooks as the validation. What a month covers is agreed in writing before the retainer starts.
Delivery periods start on the agreed date, once I have the method description, the plan where there is one, and the complete data for the package. Your quotation confirms the scope, the inputs I need from you and the revisions included. A method of unusual complexity, a multi-analyte LC-MS/MS panel for instance, is quoted individually. A laboratory with data already in hand usually needs the analysis; a laboratory about to start needs the plan first.
6 steps
How it works
- CallThirty minutes, free: the method, the guideline you follow, what data exists, and the deadline.
- QuoteScope, inputs, revisions and a fixed price in writing, within two working days.
- PlanThe validation plan and gap check delivered; your laboratory reviews and approves them before anything is run.
- BenchYour team runs the experiments. I answer questions as they come up.
- ReportYou send the raw data; I return the statistics and the draft report within the agreed period.
- ReviewOne round of revisions after your review is included in every package; the full-support package also covers one round after the assessor’s review.
Calls Monday to Friday, 09:00 to 11:00 Stockholm time, with 08:00 slots on request. I work from Japan, which is why the slots are in the Swedish morning.
12 kinds of study
Relevant experience
Fifteen years inside clinical laboratories, 2009 to 2024. At ABC Labs I wrote the guideline the laboratory’s method validations are run against, twelve kinds of study and a map of which kind of method has to pass which, and ran the technical side of taking a covid testing operation to an accredited toxicology scope, ISO 15189 and EWDTS. Before that, eleven years in clinical pharmacology at Karolinska University Hospital, where the drugs-of-abuse laboratory was accredited by the College of American Pathologists as well as by Swedac, so the validations written there had to satisfy the US checklist and the ISO standards at once.
- 12Kinds of study in the validation framework I wrote
- 3 papersPeer reviewed, each one a validated method
- 22 monthsFirst day to an accredited toxicology scope, with QA alongside
Three of the methods are published and peer reviewed, one with me as first author, which is the closest a validation gets to being checked by strangers. The framework, the commissioning evidence and the quality system around them are on the selected work page; the license, the dated roles and the papers are on the about page.
Yours to sign
Responsibilities and ownership
The method is yours, the data are yours and the approval is yours. I design the plan, read the data and write the report; your laboratory director decides whether the method is fit for its purpose and signs the validation off, as the standard requires. The plan and the report are written for you, in your templates, and belong to you. The workbooks are delivered for your continued use; the methods and templates behind them stay mine, so I can keep offering the same work to other laboratories. I work under your document control, and I will sign your NDA before I see a number.
Everything on this page is remote. If the work needs me at the bench, for a method transfer, a commissioning or a laboratory being stood up, that is a different engagement, priced as one, and the commercial answers apply. If what you need is an independent body to assess the validation rather than somebody to prepare it with you, I am not the right call and will say so on the first conversation.
Six services
First step
Discuss your method
The method, the matrix, the guideline you work under and the date you need it by. If you already have data, say so; a gap check is often the cheapest first step. Within two working days I will tell you which studies I would plan and what the package costs. The terms, travel and the other commercial answers are on the contact page. If you would rather not use a form, write to [email protected].
Contracting
- Consulting delivered through Ebihara Solutions (Sweden), a sole trader approved for F-skatt; organization and VAT numbers on every invoice.
- Your NDA signed and your document control followed; no professional indemnity insurance; laboratories in Sweden, Europe and the Asia-Pacific.