VALIDAT Laboratory Software for Method Validation
The simple and efficient solution for the validation process
Method validation is essential
When a new analytical method has been developed or modified, it is essential that this method is validated. The systematic verification of the suitability of a method often requires a lot of time and money – especially when the right tools are not available and the planning, investigation and performance of all necessary steps are carried out with the help of various aids, which in turn must be secured by means of complex review processes.
The planning of the investigations – while avoiding duplication – is a cumbersome business. The distribution of the tasks among the laboratories, people and measuring instruments involved is time-consuming, and the subsequent manual amalgamation of the measurements is prone to errors. The statistical and graphical evaluation, as well as report preparation which are subsequently required involve substantial effort.
iCD. offers impressive software for all of these method validation considerations and activities: VALIDAT. With its sophisticated, extensive functionality, the leading VALIDAT laboratory software for method validation supports method validation activities from planning a project to automatic evaluation and reporting. All of a company’s validation projects can be planned, implemented and managed centrally, regardless of the different methods used. Report templates allow all validation results to be created uniformly and automatically and stored centrally in the DMS.
How VALIDAT, our laboratory software for method validation, will support you
VALIDAT offers all the mathematical and statistical processes you need for the successful completion of your method validation projects – as well as full 21 CFR Part 11 compliance. Thanks to its well-structured work processes and flexible, customisable templates, VALIDAT laboratory software will organise your validation processes in a simpler, more efficient manner. Here is an example of a typical workflow:
- Planning a validation:
Planning can be performed with the aid of an assistant and a wide range of templates. When a new project is created, information from an external system (e.g. LIMS) can be integrated. Revision of the project and electronic approval, with corresponding audit trail, are also supported.
- Performance of examinations:
After electronic approval – as the starting point for processing – sequences can be transmitted to a CDS (chromatography data system), for example, or to other measuring systems or a LIMS. As part of this process, the measurements that need to be taken for the wide range of samples are reduced to a minimum.
- Recording measurements:
Measurements can be recorded manually, or can also be automatically imported into VALIDAT. As part of this process, a wide range of measuring instruments and LIMS interfaces are supported, in addition to an Excel interface (see Interfaces to VALIDAT).
- Evaluation and reporting:
Once all measurements have been stored in VALIDAT, the statistical evaluation and the assessment of the results is performed. A report can be created at any time. The report template can be used to determine the scope of the report (e.g. with the entire collection of forms, images, measurements, etc.) and its appearance. 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, sophisticated laboratory software for method validation
VALIDAT laboratory software supports laboratory workers in all phases of the method validation process, from planning and implementation to evaluation and reporting. These activities are made easier because of various interfaces. Transmission errors and unnecessary work are eliminated. The development of VALIDAT to date and its future development will ensure that you can fulfil current and future requirements.
Save considerable time and costs
Up to 70% of the time spent on manual method validation is required for planning, calculations and evaluation, and reporting. This does not take into account the fact that, particularly in regulated environments, it is also necessary to validate and qualify the calculations and statistical evaluation as well as the reporting. With VALIDAT, these time-consuming tasks are no longer necessary.
Reduce risks through automated method validation
VALIDAT laboratory software supports the entire workflow using automated processes and preventing manual data entry errors. Every amendment and status change is logged as part of the audit trail and can therefore be traced. Even during planning, it is ensured that the necessary information for the statistical calculations has been provided. Transmission errors are prevented through the automatic provision of the information for validation and the automatic transfer of measurements. All calculations are validated. Any discrepancies throughout the method validation process are immediately flagged.