"Methodenmanagement" refers to the management and organization of various analysis or examination methods in a laboratory or scientific facility.
Typical functions of software in the "Methodenmanagement" domain include:
Method development: Support for the development of new analysis methods or adaptation of existing methods to specific requirements.
Method documentation: Capture and documentation of information about each analysis method, including procedure steps, requirements, and reference materials.
Validation and qualification: Conducting validation and qualification processes for analysis methods to ensure they deliver reliable and reproducible results.
Calibration and control: Monitoring calibration and control processes for devices and instruments used in the analysis methods, as well as logging calibration and control results.
Update and revision: Management of updates and revisions to analysis methods according to new findings, technologies, or regulatory requirements.
Training and qualification: Providing training materials and programs for staff to qualify them in handling new or updated analysis methods.
Compliance and audit: Supporting compliance with quality standards and regulatory requirements by documenting method validation, qualification, and revision.
Reporting and analysis: Generating reports and analyses on the effectiveness, reliability, and performance of the analysis methods used.
