Analytical method validation · GMP · ICH Q2(R2)
Validation protocols without hours of retyping, with errors caught before review.
Ekvo is a working prototype for writing validation protocols for analytical methods. We are looking for laboratories to help shape it.
An online meeting: we show you what we have, and we would like to hear how you do it.
The problem
A validation protocol takes hours to write. Errors only show up at review.
Most of the work on a protocol is not science. It is retyping the same data, adjusting tables and hunting for inconsistencies between chapters.
Is it the same for you? We would like to hear where it hurts most.
The same data, again and again
The product name, the method number and the batch numbers are retyped in every chapter. One typo is enough.
Tables adjusted by hand
Every batch, impurity and sample needs its own rows and columns, and someone has to check that they match everywhere.
Criteria from the last protocol
Limits are copied from older documents and are easily mixed up between methods or purposes.
Errors are found late
Inconsistencies between chapters are only caught by QA at review, and the protocol goes back for rework.
What already works
From the method to a finished protocol
The method and its parameters
Validation or verification, the method (GC, HPLC, LC, UV-VIS, titrimetric or another), the validation parameters, the product and its substances, and the purpose of the test.
Acceptance criteria suggested from your values
Ekvo suggests criteria from your company’s in-house values for the method and the purpose of the test. You can edit every one.
A consistency check of the protocol
You enter the substances and their limits, the batches, the product and the method number once, and every chapter takes them over. Fixed rules then point out what does not match: a QL above the specification limit, a DL not below the QL, a range that does not cover the limit, a chosen parameter without a criterion.
A finished protocol on your template
The protocol is written in the structure your company uses, with your own document and form numbers, ready for review.
This is how the current version works. How it should work in your laboratory is what we want to find out with you.
Control and trust
The analyst brings scientific judgement. Ekvo does the retyping, the calculations and the cross-checks, and for every result shows what it is based on, so they can check it.
Your template and your criteria
The protocol is written on your own template, not a generic one. Suggested acceptance criteria come from your company’s in-house values for the method and the purpose of the test (assay, purity, related substances, residual solvents and more).
The analyst decides
Every criterion is editable. What Ekvo suggests is only a suggestion: the analyst accepts or rewrites it, and the analyst signs the protocol.
Exact checks
The consistency check uses exact rules, not estimates. An AI assistant adds a second, advisory check and never decides.
- Warning: QL above half the specification limitImpurity C: QL 0.09% · limit NMT 0.15%
- Error: DL is not below QLImpurity A: DL 0.05% · QL 0.05%
- Warning: Range does not cover the specification limitUpper end 80% · usually at least 100%
- Passed: Every chosen section has a criterion
What Ekvo does not do
Ekvo writes the protocol. It does not perform the validation, does not record results and is not an electronic signature system under 21 CFR Part 11.
What we want to learn
What we would like to find out
Every laboratory writes protocols differently. Before we develop further, we want to learn how you do it.
Let’s talk- How are protocols written today, and in which system do you write and approve them?
- How many validations and verifications do you run a year, and how long does one protocol take?
- Where do the errors that come back from review arise?
- Where do your acceptance criteria come from?
- What would a tool have to meet for you to use it in a GMP environment?
Who it is for
We are looking for QC and QA laboratories that validate analytical methods
- Manufacturers of human medicines
- Manufacturers of veterinary medicines
- API manufacturers
- Contract QC laboratories and CDMOs
- Biotech QC
Analytical chemists, QC managers and QA approvers. In Slovakia and Czechia.
Do you validate methods under other rules (ISO 17025, food, cosmetics)? Let’s talk about whether Ekvo would work for you too.
Write to usPilot partners
From a first conversation to a pilot on your methods
One hour online
We show you the prototype and listen to how you work. No commitment.
On your methods
Selected laboratories try Ekvo on their own methods and decide with us what it should do.
Annual licence
Pricing is individual, set to your company’s needs.
Questions
Frequently asked questions
Does Ekvo have to be validated as a computerised system (CSV)?
Today Ekvo prepares the protocol, which the analyst checks and signs outside the application, following your company’s procedure. Ekvo does not manage electronic signatures, perform the validation or record results. Electronic signatures and validation documentation are planned for later. What your QA needs for them is what we want to find out with you.
We write protocols differently from what you describe here. Is it worth meeting?
Yes, that is exactly what we want to find out. Tell us how you work, and we will judge together whether and how Ekvo would fit.
What if our protocol form changes?
Ekvo supports updating the form. Your company’s administrator uploads the new version to the app.
What stage is Ekvo at?
A working prototype. We are looking for our first pilot partners and want to build further development on the experience of several laboratories.
What does it cost?
An annual licence, individually priced to your company’s needs.
Who is behind it
Who develops Ekvo
We built and tested the application on real, approved validation protocols.
Andrej Bíro
BSc in Computer Science from the Faculty of Informatics and Information Technologies, Slovak University of Technology in Bratislava. More than 10 years building native Android applications for health insurers, retail execution, fiscalisation and consumers. Experienced in shipping reliable software in healthcare, retail and fintech.
Meeting
Let’s talk
We show you what we have and listen to how you work. The meeting is online and without obligation.
What happens next
Once you send the request, we will get back to you and arrange a time for an online meeting.