Throughout more than twenty years, VALIDAT established itself as the leading software solution for efficient method validation. Today VALIDAT supports validation documentation according to regulations for our customers in pharmaceutical, chemical, or biotechnical industries, in petrochemistry, materials test, or in car industries: reliable, professional and secure.
Gain more profit for your work from our competence. VALIDAT helps you in saving up to 70% of time and costs in method validation.
Better Overview, Less Costs
From more than 20 years of practical experience we know: method validation is an essential task in every analytical laboratory. The systematic verification of a measurement method’s suitability often leads to high expenditures of time and costs — especially where the appropriate analytical tools are missing and the planning, testing and execution of all necessary steps are carried out with standard office applications that must be assured by the use of expensive review processes.
Which parameters of a method must be considered?
Which statistics are relevant?
Do the calculations comply with the regulations and guidelines?
Operation procedures must be reviewed and approved.
Measurement values must be transferred via cross-check procedures.
We offer a convincing solution for all these questions: VALIDAT, the leading solution providing certified quality for all types of method validation.
Secure Method Validation Solution in Certified Quality
VALIDAT has been designed according to the strict regulations of DIN EN ISO 9001: 2008 and GAMP. In this, two principles have been given priority:
High user-orientation that consequently represents the needs of daily laboratory practice.
Smartly organized and automated workflows, supporting and considerably simplifying each type of method validation.
Using VALIDAT, your method validation projects will be securely stored in local files or on Oracle/Microsoft SQL servers. Due to the various interfaces to results files, data systems and our LIMS LABS/Q®, VALIDAT can be integrated effortlessly in your laboratory infrastructure.
Increased Efficiency in Method Validation Processes
To carry out your validation projects successfully, VALIDAT provides all mathematical and statistical procedures and full 21 CFR Part 11 compliance. Due to well structured workflows and versatile adjustable templates, VALIDAT organizes your validation processes more easily and efficiently:
You can release validation plans electronically and use them as a starting point for sequences in CDS or as inspection orders within LIMS.
VALIDAT imports measurement data with a click and a complete validation report is created within minutes.
You simply use successfully completed validation projects to create a template that will serve as a starting point for further projects.
Alternatively you use the template assistant and merely add the required components to your project.
Using VALIDAT, your method validation reports are created using pre-defined layouts. Furthermore, VALIDAT provides a lot of options to arrange comments and graphics in your report individually. Using text variables and acceptance definitions will assist you with creating result summaries and acceptance tables effortlessly and quickly. You will get a convincing and clearly arranged method validation report. The integrated text processor component offers a powerful environment for editing your texts:
Compatibility with Excel and Word (clipboard)
Formatting of paragraphs and characters
Whether you are handling title pages, data system report, list of materials, chromatograms or company logo — by using VALIDAT you can arrange your report according to your corporate design.
Easy Integration in Your Infrastructure
It is quite easy and effortless to adjust VALIDAT to the infrastructure of your company and to your workflows. The following three examples illustrate implementation and configuration for various company sizes of our customers.
Contract laboratory (3 users)
Installation on single desktop with three users
Validation planning and data is kept in files on local file system
Full audit trail and document management system (DMS)
Medium-sized biotechnology company (20 users)
Installation on desktops using installation packages
Validation projects are stored on Oracle database server
Central user management and system audit trail
Central document management system
Pharmaceutical or chemical company (150 users, 5 departments, worldwide)
Installation on Citrix XenApp server
No need to install clients
Validation projects are stored on Oracle database server organized in five separated groups
Central user management for each group and system audit trail
Your Advantages with VALIDAT for method validation
iCD. offers assistance and support at each stage of the project. Beginning with DQ up to the final system qualification we help you on-site with our experienced employees in establishing the very best solution for method validation in your company.
VALIDAT supports you in considerably saving time and costs for method validation:
Saving time during planning and performing method validation projects
No validation of calculations is required
Templates for recurring tasks
Reduce risks by the use of an automated software solution for method validation: