Method Validation

What is Method Validation?

Method Validation Editing

With Method Validation v, you can check your analytical and diagnostic methods to meet the demands of regulatory compliance.

The leading software package for method validation for over 20 years.

Analyze-it was developed for and is being used in thousands of laboratories accredited by ISO/IEC 17025, medical laboratories accredited at ISO 15189, medical laboratories regulated by CLIA '88 and IVD manufacturers for development, support, product labeling and FDA 510 (k) submissions.

Validate and verify the performance characteristics of the measurement system with Method Validation

It is essential to ensure that the performance characteristics (accuracy, accuracy, linearity, interference, detection capability) of a measurement procedure meet the requirements for intended use. Manufacturers (IVD companies) must establish performance during product development to get feedback on the development process, for FDA 510k shipments and product marketing, and to support customers in the field. Laboratories should verify that they can achieve the performance claimed by the manufacturer during the implementation of a new measurement system, during regulatory inspections (in accordance with CLIA '88) and as part of proficiency testing schemes (PT). Measurement systems analysis (MSA) allows you to determine all these important performance characteristics in one analysis.

Examine diagnostic test performance to find the most effective solution

Best ROC curve software rated in Clinical Chemistry March 2003 vol. 49 no. 3 p. 433-439, Analyze-it allows to establish and compare the ability of a diagnostic test to correctly diagnose patients. Explore how the test differentiates positive and negative cases and explores optimal decision thresholds, considering the costs of diagnostic errors.

Compare methods and evaluate the impact of making changes with Method Validation

When introducing a new measurement procedure, you want to see how it compared to your existing procedure or evaluate its performance against the gold standard. Bland-Altman allows you to see the agreement between the methods and what effect the differences between the methods can have on clinical interpretation. More advanced procedures, such as Deming regression and Passing-Bablok, inform bias between methods, how medical decision points can be affected, and allow testing whether bias meets performance requirements.

Establish reference intervals for clinical diagnostics with Method Validation

Reference intervals are essential for physicians to interpret the results and make a diagnosis. As a lab, it is your job to provide normal reference intervals that they can rely on. With the widest variety of methods available in any software package, the ability to partition intervals by factors such as gender, age, ethnicity, Analyze - makes it easy to establish reference intervals or transfer to a new measurement procedure.

Integrated with Microsoft Excel, it is easy to use ...

You're right, i'm not going to Analyse-it integrates with Microsoft Excel 2007, 2010, 2013, 2016, 2019, and Office 365 for Microsoft Windows. There's virtually no learning curve, and the intuitive user interface and task-based logical workflow make sense for those who aren't programmers or full-time statisticians.

All your data and results are kept in Excel workbooks, making it easy to collaborate and share with colleagues, which means there is no locked file format.

System requirements:

CPU: 1.8 GHz dual core processor

RAM: 2 GB

HDD / SSD: 50 GB of free space on the main drive

Operating system: Microsoft Windows 8 32-bit, Microsoft Windows 7 32-bit and Microsoft Windows Vista 32-bit

Resolution: 1024×768