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Compliance software improving laboratory effectiveness
Date Added: July 17, 2011 01:31:31 PM
Author: Antorr
Category: Health

If a pharmaceutical company wants to be successful on the market over a long term, it must continuously deliver high-quality products and supporting services. Quality improvement has become a key national and international business strategy. Most companies are using quality management systems as a method of assuring consistency and conformity of products to a defined set of standards or customer's expectations. Nevertheless, finally the pharmaceutical products have to be tested in specialized pharmaceutical laboratories to show compliance with the specified chemical, microbiological and physical requirements ensuring that the products are harmless, deliver the desired effects and do not cause any unexpected side-effects. Since the Quality Control laboratories are responsible for quality testing, they have to employ highly qualified personnel, check the performance of the equipment, validate test methods to show their fitness for the intended purpose, keep laboratory records, and much more. All those procedures are standardized. Therefore, any laboratory conducting testing has to obtain GMP (Good Manufacturing Practice) and/or ISO 17025 certificate. The certificate guarantees that the laboratory is meeting the global requirements to ensure validity and global comparability of the test and calibration results. EffiValidation - compliance tool for testing and calibration laboratories The global quality standard for testing and calibration laboratories is ISO/IEC 17025. Fulfilling its requirements is a basis for achieving laboratory accreditation awarded by a local accreditation body in the given country. ISO 17025 represents a compact quality system aiming at assuring the ability to consistently produce accurate, reliable and well documented results. Anything that is not documented and traceable in primary records is considered to be a rumor and is regarded by the assessors as „not being done“. Consequently, most laboratories use proven and certified software that gathers all the relevant information. Many of them make use of the EffiValidation software. This application has been designed by an international company called EffiChem. It does not work only as a “logbook”. EffiValidation is a complex tool applicable for the analytical method validation, estimation of uncertainties, calibration, creation of control charts and interlaboratory comparison. This software enables to statistically evaluate any kind of analytical data, including HPLC, GC, UV/VIS, AAS, AES, ICP, titration, dissolution, determination of a particle size, etc. The method validation criteria that can be evaluated by the software are: • Repeatability • Accuracy • Linearity • Reproducibility • Selectivity/Spe¬cificity • Limit of Detection/Quan¬titation • Robustness/Rug¬gedness • Sensitivity • Range and • Intermediate precision EffiChem designed this program in modules which means that the EffiValidation software can be easily modified or customized according to the user requirement specification. This makes this software a multi-purpose and very flexible tool. With respect to the software compliance and validation, it also has to meet the global ISO standard and health care requirements. EffiValidation was developed to be fully compliant with ISO 17025 and GxP guidelines. It conforms to the FDA 21 CFR Part 11 guideline for electronic records and signatures. These features are being appreciated by laboratory specialists all over the world and they help EffiChem to make this software even better, more effective and easy to use. About EffiChem EffiChem is an international company aiming at providing analytical laboratories with compliance support. It was established in 1999 by an analytical chemist and a computer engineer. They together started to offer the first laboratory application to small local laboratories conducting testing, method validation and calibrations and helped them to achieve the ISO 17025 certification. In few years, EffiChem became a well known globally operating company, with installations employed by hundreds of laboratories over the world. Homepage: http://www.effichem.com
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