Software solutions

OUR SOFTWARE SOLUTIONS

Qualilab markets and supports the following software, all offered as Software as a Service (SaaS): internet access, a web browser, and an annual subscription are all you need—no installation, no maintenance required.

e.noval is a software solution dedicated to the validation of physicochemical analysis methods, whether relative (LC, GC, EC, AAS…) or absolute (titration, UV…). With a wide range of statistical models (linear or quadratic regressions, weighted or not, forced through zero or not, with or without data transformation), it allows you to easily determine the response function that best fits your calibration standards. After adjustment, models are ranked according to the quality of the accuracy profile obtained. e.noval lets you enter data for calibration standards prepared with and without matrix to evaluate matrix effects by observing their impact on the accuracy profile.

e.noval implements ICH, FDA, Washington Conference, and ISO recommendations for analytical validation. It incorporates the most recent scientific concepts such as the accuracy profile based on total error, risk management related to routine use of your method, the risk profile in case of exceeding acceptance limits, and uncertainty estimation. 

It follows the methodology “VALIDATION OF QUANTITATIVE ANALYTICAL PROCEDURE: HARMONIZATION OF APPROACHES - REPORT OF AN SFSTP COMMISSION (STP PharmaPratiques Volume 13(3), 101–138, 2003)”.

Stab.e.lity allows you to determine the validity periods and expiry criteria for stability studies (whether long-term or accelerated). It generates reports in accordance with current regulatory guidelines (ICH Q1E, etc.).

Transval is a software solution dedicated to evaluating the transfer of an analytical method from a sending laboratory to one to five receiving laboratories. It uses the concept of total error and equivalence testing to let you graphically assess whether the receiving laboratory’s results are sufficiently close to the average result from the sending laboratory.

Thanks to the reports generated by Transval, you know—and therefore control—the risk associated with transferring your analytical method.

Seelva is a software solution dedicated to validating analytical methods for immunoassays, such as ELISA, RIA, and similar techniques. It offers several statistical models (4PL, 5PL, quadratic, log-log, power, with or without weighting) to help determine the response function that best fits your calibration standards. After adjustment, models are ranked according to the quality of the accuracy profile obtained.

Seelva implements the recommendations of AAPS, ICH, FDA, Washington Conference, and ISO for analytical validation. It integrates the most recent scientific concepts including the accuracy profile based on total error, risk management for routine use of your method, the risk profile in case of exceeding acceptance limits, and uncertainty estimation. 

It follows the methodology “VALIDATION OF QUANTITATIVE ANALYTICAL PROCEDURE: HARMONIZATION OF APPROACHES - REPORT OF AN SFSTP COMMISSION (STP Pharma Pratiques Volume 13(3), 101–138, 2003)”.

Our training courses

As a certified training organization, Qualilab offers training modules related to these software solutions:

• 3M1: Applied statistics in analytical development and quality control
• 3M2: Analytical validation and transfer
• 3M3: VAnalytical validation with e.noval
• 3M5: Analytical validation with Seelva