After the detection method is adjusted, old tasks still need to indicate the version used. Only the latest files are saved in the database, making it difficult to trace historical results. LIMS method management should establish a traceable relationship between method versions, task configurations and original records to avoid current definitions changing past records.
How to arrange records and operations
The method file contains applicable projects, versions and effective ranges, and the relevant parameter templates will be released after confirmation. Record the selected version when assigning tasks, and retain the reasons and confirmation steps if there are changes during execution. Disable version restrictions for new task references, and historical queries and attachments are still provided under authorization.
Method files, parameter templates and calculation rules can be revised independently, but the compatibility of the three needs to be confirmed when publishing. Task binding determines the version combination and cannot just record the method name. When the method is suspended, list the tasks that have not yet been executed and those that are being executed, and the business positions will confirm and arrange them respectively. Auditors can check the validity basis and version differences. Maintain a stable reference after the storage location of historical attachments is changed to avoid that the task record still has a version number but the actual file has been overwritten, making it impossible to review the content of the method used at that time.
Specific scenarios that need to be checked
For example, when a method is updated and calculation parameters are adjusted at the same time, the basis for testing new and old tasks should be found separately. The original data cannot be automatically recalculated and overwrite historical results due to template changes. When recalculation is required, a new result record is generated and the rules used are explained alongside the original results.
