All validation projects of a company can be planned, processed and managed centrally, independent of the different methods. By means of report templates, all validation reports are automatically generated uniformly and stored centrally in the DMS. Thanks to well-structured workflows and flexibly adaptable templates, the laboratory software VALIDAT organises your validation processes more easily and efficiently.
A typical workflow is listed below:. Planning of a validation: Planning can be carried out on the basis of an assistant and various templates. When opening a new project, information from an external system, such as a LIMS, can also be included. A revision of the project and also the electronic release with the corresponding audit trail are supported. Carrying out the studies: After the electronic release — as a starting point for processing — sequences can be transferred to a CDS chromatography data system , to other measuring systems or to a LIMS, for example.
In this way, the measurements required on the most varied samples are reduced to a minimum. Recording of the measurement data: In addition to the manual acquisition of the measurement data, they can also be automatically imported into VALIDAT.
Evaluation and reporting: After all measurement data have been stored in VALIDAT, the statistical evaluation and the assessment of the results are carried out. A report can be generated at any time. The scope of the report e. Every report and every change is documented in the integrated DMS. Proven laboratory software for method validation The laboratory software VALIDAT supports the laboratory staff in all phases of the process of method validation, from planning and execution to evaluation and reporting.
Various interfaces facilitate these activities. All the features from the Analyse-it Standard Edition are included so you can improve processes and products by identifying solutions using hypothesis tests and model fitting techniques. That's right. Analyse-it integrates into Microsoft Excel , , , , and Office for Microsoft Windows. All your data and results are kept in Excel workbooks, making it easy to collaborate and share them with colleagues, and meaning there's no locked-in file format.
We've developed software for method validation for more than 25 years, and popularized statistical procedures that have since been adopted into method validation standards and guidelines.
But it's our customers that matter - the independent laboratories, regulatory agencies, and many of the world's top ten IVD companies. Check out the latest reviews on Capterra , in the meantime here are a few of our customers With Analyse-it, I pull in the data and quickly analyse it, and then prepare figures for manuscripts right there. From the beginning of the project to completion, using one application saves me probably a day's worth of time.
Analyse-it has a tremendous advantage in its ease of use. With other programs, you really have to study how to use them, but Analyse-it makes it so easy, and at the same time offers the advanced procedures we need like Weighted Deming regression.
You might have heard Microsoft Excel isn't up to the job of statistical analysis. It isn't. The built-in functions just aren't built for accuracy. So we don't use a single one. Instead, Analyse-it handles all of the calculations internally, using reliable algorithms and IEEE double floating point precision. And the results to prove it? We've conducted thousands of tests to put Analyse-it through its paces. They cover all releases and service packs of Microsoft Excel , , , , and Office What's more, validation tests are run automatically after every change to the software so you can be confident the statistics are correct.
And stay correct. No need to resort to old textbooks. Method Validation Edition Validate and verify your analytical and diagnostic methods to meet the demands of regulatory compliance. The leading software package for method validation for over years. We use Analyse-it frequently for our verification and pre-verification work, in accordance with CLSI guidelines for in-vitro diagnostics. We use Analyse-it for the analysis of data necessary to file k. I used Analyse-It for many product development, product troubleshooting, and technology evaluation activities Analyse-it has been a tremendous help.
I've published and presented at national cardiology meetings and couldn't have accomplished most of my research without it. Using Analyse-it, I even found errors or omissions in the work of our statistician!
Compare methods and evaluate the impact of making changes When introducing a new measurement procedure you want to see how it stacks-up against your existing procedure or evaluate its performance against the gold-standard.
Establish reference intervals to make clinical diagnoses Reference intervals are essential for clinicians to interpret results and make a diagnosis. Read about the Standard Edition Plus it includes the Standard Edition Integrated into Microsoft Excel, so it's easy to use Software you can trust We've developed software for method validation for more than 25 years, and popularized statistical procedures that have since been adopted into method validation standards and guidelines. Accurate and reliable You might have heard Microsoft Excel isn't up to the job of statistical analysis.
Validated, tested at every stage We've conducted thousands of tests to put Analyse-it through its paces. Dependable support No need to resort to old textbooks. Take a look for yourself.
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