Save up to 70 Percent of Time and Costs in Method Validation

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 percent of time and costs in method validation.

Additional Modules

Besides method validation acc. to DIN/ISO/EP/USP/JP/ICH/FDA there are numerous additional modules for the following applications

• Error of Uncertainty acc. ISO 17025
• Bio-assays acc. EP4, 5.3
• Round-Robin-Tests
• Dissolution

Dissolution

The Dissoluton module is a comprehensive extension to plan, calculate and report dissolution experiments.
VALIDAT supports data import from measurement systems as well as calculation of all relevant parameters incl. f1-/f2-values for profile comparison.
All dissolution runs are available in a comparison database that allows fast and flexible retrieval and combination of runs.

Lab Integration

VALIDAT seamlessly integrates into your lab environment and allows - besides LIMS, CDS and SAP integration - transfer of existing dissolution and method validation data.
Powerful interfaces support easy and compliant legacy data transfer.

Integrated Qualification

The fully automated Installation Qualification (IQ) and Operation Qualification (OQ) check installation files (version, size, checksum) and reporting (calculation, report creation) within a few minutes.
IQ and OQ reports are saved within the document management system and, thus, are available for documentation purposes.

VALIDAT’s benefits

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

Summary

• Fully validated easy-to-use software developed in compliance with FDA 21 CFR Part 11 and GAMP 5 regulations
• Easy validation setup using templates
• Validated statistical functions in compliance to DIN/ISO/EP/USP/JP/ICH/FDA
• Use interfaces to leading chromatography data systems
• Create reports with a single click
• Establish workflows fully supported by our software
• Powerful additional modules

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