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
INTRODUCING ENOVAL
- ☑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
- ☑Our statisticians provide a support (hotline) for any questions concerning the use of the software and the processing of your data
- ☑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
Our experts are at your disposal to help create your SOPs, protocols and experimental plans
Link to Enoval documents
(Brochure, Quality documents, Quick-start Guide, Excel Template, Sample Datasets)
WHO USES OUR SOFTWARE
BUY TODAY, USE TODAY, JUST CONNECT AND GO
Choose one or both of the following to be convinced:
A real demonstration with one of our statisticians
(Conference Call)
A FREE 10 business days, 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
RECENT NEWS & EVENTS
Analytical Procedures & Methods Validation
December 4-6, 2017 The laboratory landscape continues to face an influx of regulations surrounding the reliability, consistency and accuracy of analytical methods and data. From FDA’s final guidance on analytical procedures to USP chapter updates to FDA and MHRA’s...