- Technical assistance and studies
Development
and validation of analytical methods
Development, optimisation, validation and transfer of customised analytical methods
Need for reliable and validated analytical methods
The introduction of new methods, the adaptation of procedures to new matrices or analytes, the development of rapid methods and sensor-based technologies, as well as regulatory and technological changes, make it essential to ensure that methods are fit for their intended use, particularly in environments subject to ISO/IEC 17025 accreditation.
Our solution
AINIA offers a comprehensive service for the development, validation, verification and transfer of analytical methods, based on the extensive technical experience of its laboratories and work under recognised quality systems.
The studies are tailored, taking into account the matrix, the analyte and the analytical objective.
The necessary parameters (accuracy, precision, specificity, linearity, detection/quantification limits or robustness, as applicable) are assessed to demonstrate the performance of the method.
AINIA has numerous techniques accredited in accordance with UNE-EN ISO/IEC 17025, ensuring rigorous, traceable and defensible validation.
Expert interpretation of the results makes it possible to establish the scope and limitations of the method in a clear, documented and defensible manner for audits or accreditation processes.
This experience applies both to official or standardised methods (ISO methods, molecular biology, pharmacopoeia…) and to the validation of new rapid methods developed using sensors or digital solutions, comparing their performance against reference methods.
Applications
- Development and optimisation of new analytical methods using different techniques, including spectrophotometry, colorimetry, ELISA, LC-MS/MS, CG-MS/MS, ICP-OES, ICP-MS, molecular biology techniques (PCR-rt…), plate culture, among others.
- Validation and revalidation of methods for quality and safety control and R&D.
- Adaptation of existing methods to new matrices or conditions of use.
- Validation of rapid methods (e.g. molecular biology) and sensor-based technologies against official or standardised methods.
- Technical support (in situ or at the client’s own facilities) for the implementation and transfer of methods in laboratory or industrial environments.
- Preparation of documented validation and analysis procedures for the client.
Impact and benefits
- Analytical methods suitable for their intended use.
- Robust, reproducible and traceable results.
- Reduction of technical and regulatory risk.
- Solid technical basis for audits, inspections and ISO/IEC 17025 accreditation processes.
- Reliable validation of rapid methods, facilitating their use in in-process control and agile decision-making.
Would you like to know more?
Leave us your details and we will contact you to answer your questions or continue the conversation.
