VALIDAT Method Validation Lab Software
Method validation is essential: The simple and efficient solution for validation processes
If a new analytical method has been developed or modified, it is essential to validate this method. Systematically verifying the suitability of a method often requires a great deal of time and money, especially if the right tools are lacking and the planning, verification and execution of all the necessary steps is carried out using different tools. This in turn requires elaborate review processes for validation.
The planning of the examinations, while avoiding duplicate examinations, is time-consuming. The distribution of tasks to the laboratories, persons and measuring instruments is time-consuming, and the manual subsequent consolidation of the measurement results is error-prone. The statistical and graphical evaluations that are then necessary, as well as the preparation of reports, also require a great deal of effort.
For all these questions and activities of method validation, iCD offers a convincing software: VALIDAT. The market-leading method validation laboratory software VALIDAT supports with its mature and comprehensive functionality the tasks of method validation, from the planning of the project, to the automatic evaluation and reporting. All validation projects of a company can be planned, processed and managed centrally, independent of the different methods. Using report templates, all validation reports are created automatically in a uniform manner and stored centrally in the DMS.
This is how our method validation laboratory software VALIDAT can support you
For the successful execution of your method validation projects, VALIDAT offers all mathematical and statistical procedures as well as full 21 CFR Part 11 compliance. Thanks to well-structured workflows and flexibly customizable templates, VALIDAT laboratory software organizes your validation processes more easily and efficiently. Below is a typical workflow:
Planning of a validation:
Planning can be done on the basis of a wizard as well as various templates. When opening a new project, information from an external system, such as a LIMS, can also be included. A revision of the project and also the electronic release with the corresponding audit trail are supported.
Carrying out the examinations:
After electronic release - as the starting point for processing - sequences, for example, can be transferred to a CDS (chromatography data system), to other measuring systems or even to a LIMS. In this way, the measurements required on a wide variety of samples are reduced to a minimum.
Acquisition of measurement data:
In addition to the manual acquisition of measurement data, these can also be automatically imported into VALIDAT. Various measuring device interfaces or LIMS interfaces as well as an Excel interface are supported (see Interfaces to VALIDAT).
Evaluation and report generation:
After all measurement data have been stored in VALIDAT, the statistical evaluation as well as the assessment of the results takes place. At any time a report can be created. The scope of the report (e.g. with the entire collection of formulas, images, measurement data, etc.) as well as the appearance of the report is controlled by the report template. Every report and every change is documented in the integrated DMS. The report can also be exported as a Word document and edited - independent of VALIDAT.
Your advantages at a glance
Proven and mature laboratory software for method validation
The VALIDAT laboratory software supports the laboratory staff in all phases of the method validation process, from planning and execution to evaluation and reporting. Various interfaces facilitate these activities. Transmission errors as well as unnecessary work are avoided. The past and future further development of VALIDAT assures you the fulfillment of current and future requirements.
Significantly save time and costs
In manual method validation, up to 70% of the time is required for planning, calculation, evaluation and reporting. This does not yet take into account that, especially in the regulated area, validation and qualification of the calculation and statistical evaluation as well as reporting are also necessary. This time-consuming work is not necessary when using VALIDAT.
Reduce risks through automated method validation.
The entire workflow is supported by VALIDAT Laboratory Software through automated processes as well as the avoidance of manual data entry errors. Every change and every status change is logged in the audit trail and are thus traceable. Already during the planning phase, care is taken to ensure that the necessary information for statistical calculation is available. Transmission errors are avoided by automatically providing the information for validation and by automatically transferring the measurement data. All calculations are validated. Deviations are immediately displayed throughout the method validation process.
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