VALIDAT Method Validation Laboratory Software
Method validation is essential: The simple and efficient solution for validation processes
Once a new analytical method has been developed or modified, it is essential to validate that method. Systematically verifying a method’s suitability often involves significant time and cost, especially when the right tools are lacking and the planning, verification, and execution of all necessary steps are carried out using different tools. This, in turn, requires time-consuming review processes for validation.
Planning the tests—while avoiding duplicate testing—is a complex process. Assigning tasks to laboratories, personnel, and measuring instruments is time-consuming, and manually compiling the measurement results afterward is prone to errors. The statistical and graphical analyses required thereafter, as well as the preparation of reports, also involve a significant amount of work.
For all these questions and tasks related to method validation, iCD offers a compelling software solution: VALIDAT. As the market-leading method validation laboratory software, VALIDAT supports method validation tasks with its sophisticated and comprehensive functionality, from project planning to automatic evaluation and report generation. All of a company’s validation projects can be centrally planned, executed, and managed regardless of the different methods used. Using report templates, all validation reports are automatically generated in a uniform format and stored centrally in the DMS.
Here’s how our method validation lab software, VALIDAT, can help you
To ensure the successful completion of your method validation projects, VALIDAT provides all necessary mathematical and statistical methods, as well as full 21 CFR Part 11 compliance. Thanks to well-structured workflows and flexible, customizable templates, the VALIDAT laboratory software helps you organize your validation processes more easily and efficiently. A typical workflow is outlined below:
Planning a validation:
Planning can be carried out using a wizard and a wide variety of templates. When creating a new project, information from an external system, such as a LIMS, can also be integrated. The system supports project revisions as well as electronic approval with the corresponding audit trail.
Conducting the analyses:
Once electronic approval has been granted—marking the start of the analysis process—data can be transferred, for example, to a CDS (chromatography data system), to other measurement systems, or to a LIMS. In this process, the measurements required for a wide variety of samples are kept to a minimum.
Data Entry:
In addition to manual dataentry, measurement datacan also be imported automatically into VALIDAT. The system supports a wide variety of instrument interfaces and LIMS interfaces, as well as an Excel interface (see VALIDAT Interfaces).
Analysis and Reporting:
Once all measurement data has been entered into VALIDAT, statistical analysis and evaluation of the results are performed. A report can be generated at any time. The scope of the report (e.g., including the entire formula collection, images, measurement data, etc.) as well as its appearance 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 independently of VALIDAT.
Your benefits at a glance
Proven and mature laboratory software for method validation
The VALIDAT laboratory software supports laboratory staff through every phase of the method validation process, from planning and execution to evaluation and reporting. Various interfaces facilitate these tasks. Data transfer errors and unnecessary work are avoided. The ongoing and future development of VALIDAT ensures that current and future requirements are met.
Significantly save time and money
Up to 70% of the time spent on manual method validation is required for planning, calculation, evaluation, and reporting. This does not even take into account the fact that, particularly in regulated sectors, validation and qualification of the calculation, statistical evaluation, and reporting are also necessary. These time-consuming tasks are eliminated when using VALIDAT.
Reduce risks through automated method validation
The entire workflow is supported by VALIDAT laboratory software through automated processes and the elimination of manual data entry errors. Every change and every status update is logged in the audit trail and is therefore traceable. Even during the planning phase, care is taken to ensure that the necessary information for statistical calculations is available. Transmission errors are avoided through the automatic provision of validation information and the automatic transfer of measurement data. All calculations are validated. Deviations are immediately displayed throughout the entire method validation process.
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