Your focus: Validation of physico-chemical methods
Your objectives:
- Generate reports for the qualification or validation of your analytical method both relative (LC, GC, EC, AAS,…) and absolute (titration, UV,…)
- Assess the trueness, the precision and the accuracy of your analytical method and generate accuracy profiles to support the selection of the best calibration model
- Evaluate the potential matrix effect in the calibration
- Evaluate your risk in future routine analysis
- Demonstrate that the method is able to perform accurate results in routine (reconstituted samples) but also on real samples (tablets)
- Define the optimal experimental design
Our solution: E-Noval
- ☑Use of Total Error concept
- ☑Analysis of the matrix effect
- ☑Use of β-expectation Tolerance Interval to manage the risk in routine analysis
- ☑Generate an e-CTD compliant report within minutes, in full compliance with authority expectations (ICH Q2, FDA, ISO, EMA, MHLW, USP 1210, USP 1225 and EDQM)
- ☑Decision-making tool: one graph = one decision
- ☑ Suitable for GxP use: fully validated according to the GAMP5 guidelines and 21 CFR part 11 compliant
- ☑Software as a Service (SaaS) application:
- -no installation required: no need to validate the system on site
- -no maintenance costs
- -can be accessed from any location
- -always the latest version available, free of charge
- ☑10 different statistical models proposed, easy selection thanks to the Accuracy Index:
- -Linear Regression
- -Weighted (1/X) Linear Regression
- -Weighted (1/X²) Linear Regression
- -Linear Regression Through 0. Fitted using the level X only
- -Linear Regression Through 0. Using the Highest Level only
- -Linear Regression after LOGARITHM transformation
- -Linear Regression after SQUARE ROOT transformation
- -Quadratic Regression
- -Weighted (1/X) Quadratic Regression
- -Weighted (1/X²) Quadratic Regression
Link to E-Noval documents
(Brochure, Quality documents, Quick-start Guide, Excel Template, Sample Datasets)
Choose one or both of the following to be convinced:
A real demonstration with one of our statisticians
(Conference Call)
A FREE 15 day, hands-on trial
(Live, Working Demo Version)
Statistical Software and Consulting experts for the statistical management of the development and manufacturing of your products.
Arlenda is a member of the international group PharmaLex, supporting our rapid expansion.
CONTACT INFO
Arlenda Head Office (Belgium)
Rue Edouard Belin, 5
1435 Mont-St-Guibert
Belgium
Phone: +32 10 46 10 10
Arlenda Liège Office (Belgium)
Avenue du Parc Industriel, 89
4041 Milmort
Belgium
Phone: +32 10 46 10 10
Arlenda, Inc. (U.S.)
128 Orchard Way,
Berwyn, PA 19312
USA
Phone: +1 (908) 3462181
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