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Take part in NeoLiCy® project

When operating according to quality management systems (e.g. according to GxP or ISO guidelines), statistical assessment of the analytical procedures used is of the utmost importance.

 

This includes for instance analytical methods validation, analytical stability studies, robustness, uncertainty of measurement estimation, method transfer and many others assessment steps during the analytical method whole life cycle.

 

NeoLiCy® software project is designed to fulfill all these steps requirements according to proven and established recommendations and regulations. Each new release of NeoLiCy® shall address one or several more aspects of analytical method’s life cycle statistical assessment.

 

 

  • Universally accepted

 

NeoLiCy® is developed with regard to international recommendations and regulations on analytical methods assessment. It is based on the ICH recommendations (ICH Q2(R1) on method validation, ICH Q8 on Quality by Design…), EMA, FDA, USP, EP guidelines and ISO standards related to the subject.

 

A constant technological survey of these guidelines and recommendations is the core of NeoLiCy® development specifications.

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  • Versatile configuration

 

NeoLiCy® is a configurable software designed for statistical assessment of any kind of analytical method. It contains ready to use templates related to the configuration of the statistical tests and associated calculations. These templates comply with the guidelines and recommendations for pharmaceutical, cosmetic, agro-foodstuff, environmental and chemical industry. For ease of use these templates are pre-configured and additionally the user may create and save new templates.

 

This high degree of versatility enables release 1 of NeoLiCy® to be used for the validation of all analytical procedures in any kind of industrial activity.

 

 

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  • Powerful project management

NeoLiCy® database management allows creation of up to five classification levels. The project level is the main classification level; it contains all the data and revisions of the different files, documents and chapters related to the products or compounds in the products contained in the project. The characteristic level is t he final statistical assessment level, dedicated to evaluation of a single characteristic (e.g. method validation characteristic).

 

As some of these classification levels are optional, NeoLiCy® provides a high level of flexibility in the projects content management, allowing study of several compounds in a single product or several products, study of analytical methods related to several matrices and so on.

Even the list of characteristic to be assessed for a specific analytical method may be user defined, manually or by use of chapter or document templates.

Of course NeoLiCy® user management provides tools to adapt the rights given to each user in project management tasks.​

 

 

  • Easy projects and documents creation

Once a project has been created, the user may apply ready to use document templates containing a set of characteristics to be assessed.

 

Wizards are provided to help the user in building his project and tables of content may be adapted or modified in order to comply with specific regulations or to your own company statistical assessment procedures and design of experiments.

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  • Easy data input

 

Data input in NeoLiCy® may of course be done manually, for security purpose this right is part of the user administration configuration.

 

Moreover, any data can be copied from Microsoft® Excel™ tables. Chromatographic data from Agilent OpenLAB or Hitachi data acquisition software shall be directly imported using dedicated interfaces specifically developed for these software.

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  •  Automatic calculation

 

After method characteristics assessment configuration, the user has simply to set up his specifications on results, according to the company procedure or any regulation to be applied. Calculations are carried out by a simple click and statistically checked with regards to the applied procedure. The final conclusion on each of the assessed characteristic is proposed to the user by NeoLiCy®, providing large spaces for any comment or decision depending on the calculated results. According to the user rights, the final conclusion on each characteristic can be modified and justified separately.

 

  • Automatic report compilation

 

After input of the comments and decision, the statistical assessment report is created with only a mouse click. The report may content from a single characteristic data and results up to a full project results, including or not a detailed description of the statistical procedures used.

 

 

NeoLiCy® provides the user with four different ways to create the report :

 

- As a write protected standard NeoLiCy® report

 

- As a rtf format file, compatible with Microsoft Word

 

- As a protected Adobe® Acrobat™ pdf file

 

- As an Adobe® Acrobat™ pdf file.

 

 

 

 

 

 

 

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  • Compliant with international standards

 

Whatever is the characteristic to be assessed, NeoLiCy® has been designed for full compliance with international standards and industry recommendations and regulations. 

 

Release 1 of NeoLiCy® provides statistical assessment of the following characteristics :

 

  • Specificity, according to ICH Q2(R1)  recommendations by means of analytical recordings comparison.
  • Precision (ICH Q2(R1) and ISO 5725 compliant), including repeatability, intermediate precision and/or reproducibility.
  • LOD and LOQ estimation (ICH Q2(R1) and ISO 11843 compliant), by means of the S/N ratio or calibration curve data.
  • Response function assessment: linear, linear thru zero, weighted linear, linearized, quadratic or Michaelis-Menten models, by means of back calculated concentrations residuals and/or ANOVA (ISO 11843 and NF T90-210 compliant)
 
  • Linearity (ICH Q2(R1) and ISO 11095 or ISO 8466-1 compliant), including linear thru zero model and relative residuals assessment.
  • Accuracy over a concentration range (ICH Q2(R1) compliant) by means of trueness and precision assessment or use of the total error concept (beta expectation tolerance interval and/or ISO 16269-6 compliant).
  • Accuracy at a target concentration (ICH Q2(R1) compliant) by means of trueness and precision assessment or use of the total error concept (ISO 16269-6 compliant).
  • Multi-series accuracy or interlaboratories trials (ICH Q2(R1) and ISO 5725 compliant) by means of trueness and precision assessment.

 

  • Validated and fully FDA 21CFR part 11 or EU GMP Annex 11 compliant

 

NeoLiCy® is validated and the validation certificate is included in the software package. In addition to the operating system security layer, NeoLiCy® provides all functions necessary for full FDA 21CFR part 11 or EU GMP Annex 11 compliance :

  • IQ and OQ procedures, installed together with the software.
  • User administration, based on defined user profiles (user rights).
  • Audit trails.
  • Projects management by revision.
 

 

  • Electronic signature.
  • Archiving.
  • Write protection of the software functions and calculations algorithms.
  • Write protection of the validation report.

 

  • Flexible installation

 

NeoLiCy® has been designed to operate in standalone or network environment. It supports single desktop/laptop installations, network installations with a data server or full network installation using a terminal server or a Citrix XenApp server.

 

  • Substantially time saving

 

As a comprehensive tool for analytical methods’ life cycle statistical assessment, NeoLiCy® supports the user in the different steps of the statistical assessment procedure. Substantial time savings can be realized during calculations and compilation of the report.

 

 

NeoLiCy® - the time and cost saving tool for statistical assessment of analytical methods

can save days of work.

 

NeoLiCy®  is a registered trademark. Copyright Prof. M. Righezza and Dr. J.M. Roussel

 

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