EffiValidation 4.0
+ Method Validation, Uncertainties & Control charts
+ Meeting ISO 17025 and ICH Q2(R2)
+ Fast installation, go-live and use
Characteristics a functions
Statistical data evaluation, validation of test methods, estimation of uncertainties, development and use of control charts and calibration models, evaluation of inter-laboratory studies.
General
- MS SQL or FireBird database
- Filtering and searching
Security, data integrity and traceability
- In compliance with GAMP 5, 21 CFR Part 11, Annex 11 to EU GMP
- In compliance with ISO 17025
- Functionalities: Audit trail and record history
Statistical Data Evaluation – Method validation, uncertainties, control charts, calibrations, inter-laboratory comparison
- Method validation
- Estimation of uncertainties
- Control charts
- Calibrations
- Interlaboratory comparison
LIMS: Laboratory Information and Management System
- Samples, specification, and results
- Out of Specification (OOS)
- Methods
- Equipment and calibrations
- Reference standards
QMS: Quality Management System
- Deviations
- Change control
- Audits
- CAPA management
- Risk management
DMS: Document Management Systém
- Controlled dokuments
Case Studies
VUOS has implemented EffiChem LIMS, DMS and QMS, covering all company quality needs in one system, available any time to all employees.
PVK has used EffiChem since 2000 growing from a single license to multiple labs, allowing seamless alignment and data sharing while improving data integrity and analysis for hundreds of different methods.
ImunaPharm reduced the method validation timelines by 50% and improved the way it reports to regulatory agencies, incl.
View all case studies.
Examples EffiValidation 4.0
Samples and Results
The Samples and Results module allow you to record the measured results, compare them with the specification and make the user evaluation (complies/not complies).
Methods: selection of the validation parameter to be evaluated
Selection of the validation Parameter from the Methods module – choose Full validation and then Repeatability, Accuracy, Linearity, Reproducibility, Selectivity, Limit of detection, Limit of quantitation, Robustness, Sensitivity or Blank;, and then one of the algorithms, if existing.
Linearity evaluation
An example of graphical evaluation of Linearity in the method validation module, showing the relationship between the concentration and the measured values on the Graph tab. For a more detailed evaluation, a Residual plot or supporting statistics can be used.
Linearity report
An example reporting of Linearity in the method validation module. The Report is presented on the Report tab.
Robustness evaluation
An example of graphical evaluation of Robustness in the method validation module, showing the Effects of the tested parameters on the measured characteristics.
Control chart
An example control chart in the method module – X diagram. The Control, Warning and 1 s limits are show in red, yellow and green respectively.
Products
Solutions offered
Important links
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In accordance with the regulations