ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.
The International Conference on Harmonisation brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
ICH guidelines: Validation of Analytical Procedures: Text and Methodology (http://www.ich.org/LOB/media/MEDIA417.pdf) The document presents a discussion of the characteristics and for consideration during the validation of analytical procedures. The objective of validation is to demonstrate that the method is suitable for the intended purpose. Four most common types of analytical procedures are discussed: Identification tests Quantitative tests for impurities Limit test for the control of impurities Quantitative tests of the active moiety in samples of drug substance or drug products
LabWare LIMS is a full-featured, configurable, enterprise Laboratory Information Management System (LIMS). The architecture combines the power and security of an enterprise server with the ease of use provided by a dynamic graphical user interface. LabWare LIMS is designed to be completely customer configurable, providing an unparalleled degree of client involvement in adapting the software to their specific needs.
The 100% Web based architecture increases efficiency and lowers the cost of deployment. Broad, deep functionality enables commercial out-of the box configuration. Validation scripts save you time and make your validation a lot easier. SQL*LIMS Professional Services provide highly successful LIMS projects. Certified integration with ERP/MRP systems
STARLIMS is a web-based off-the-shelf LIMS designed for a wide variety of laboratory environments operating in many scientific and industrial disciplines. STARLIMS consolidates disparate business processes into a single, compliant platform with comprehensive reporting, surveillance and networking capabilities. The result is vastly enhanced data management and sharing-within the laboratory and across the enterprise.
Method Validation Software - EffiValidation laboratory software for validation of analytical methods according ISO 17025 for accredited laboratories and GMP quality control regulations (Method Validation, Method Uncertainty, Calibration, Control Charts, Inter-laboratory Comparison, Electronic Record Books, Software Validation, 21 CFR Part 11)
Method validation consists of documenting the quality of an analytical procedure, by establishing adequate requirements for performance criteria, such as accuracy, precision, limit of detection, etc. and by measuring the values of these criteria. The goal of method validation is to prove that the method is suitable for the intended purpose. When this is achieved, the validation of analytical method is completed.
Arlenda develops, validates and commercializes an integrated suite of statistical solutions dedicated to the life cycle of analytical methods, from the optimisation to the routine analysis while being compliant with regulatory documents.
Validation Manager (http://www.chromatographyonline.com/lcgc/data/articlestandard/lcgc/482001/2985/article.pdf) Is best combined with Hitachi’s HPLC and covers the USP requirements
Is best combined with the Waters hardware and enables to evaluate the evaluate the validation parameters in line with the USP requirements.
Method validation software for IVDs, Clinical Laboratories and Researchers to validate, verify, and demonstrate analytical and diagnostic method performance.