Now online estimate
Repeatability - Level by level !
Your laboratory can have the repeatability determined in just a few seconds.
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GMP requirements
GMP quality control (GxP) laboratories
According US 21 CFR, Parts 210 and 211, Sec. 211.165:
(e) The accuracy, sensitivity, specificity, and reproducibility of test methods (HPLC, GC, titration, dissolution) employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with §211.194(a)(2).
and according EU The Rules Governing Medicinal Products in the European Union, Vol. 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice, Part I, Chapter 6 Quality Control:
6.2 The QC department as a whole will also have duties, such as to establish, validate and implement QC procedures.
This shall be done in line with the Method validation Published guidelines.
EffiValidation enables to deal with the requirements specified in these guidelines.
In addition the Control charts/trend analysis and Software validation requirements are covered.
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Main Features and Improvements
- Software validation requirements met
- Emphasis on statistical methods to validate testing/calibration methods, estimate uncertainties, develop control charts and calibration models, and to enable inter-laboratory comparison
- Database of samples, equipment calibrations, standards, chemicals, documents and complaints included
- Automated data evaluation and hypothesis testing
- Automated generation of test reports in numerical and graphical form
- Easy-to-use, intuitive handling based on Microsoft standards, feasible for all laboratory personnel
- And much more...
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