S!MPATI 4.90 Pharma: Optimized Batch Evaluation and Data Management

Certified safe: With S!MPATI 4.90 from Weiss Technik, companies can meet all regulatory requirements for electronic systems – compliant with FDA 21 CFR Part 11 and EU-GMP Annex 11. Traceable. Secure. Documented. ((Image: Weiss Technik GmbH, own image)

FDA Approved: The US Food and Drug Administration (FDA) regulates the safety of pharmaceuticals and medical devices. S!MPATI 4.90 by Weiss Technik supports pharmaceutical companies in complying with FDA 21 CFR Part 11 and EU-GMP Annex 11. (Image: Weiss Technik GmbH, own image)

From Spring 2026, Weiss Technik will deliver powerful data analysis and simplified reporting with the updated software version. The improved display offers more clarity and comfort for the user. The update is compatible with current Windows operating systems and complies with all industry-specific safety regulations.

With the upcoming adaptation of S!MPATI 4.90 Pharma to Windows 11 and Windows Server 2022, Weiss Technik is expanding the software with additional innovative features.

Simplified Batch Evaluation

The assessment of stability test samples is significantly facilitated by new evaluation tools. These features allow precise evaluation of batch storage conditions, including the assessment of activation energy of chemical reactions during pharmaceutical storage. This also greatly simplifies reporting. Supported by an optimized graphical display for more intuitive navigation, the software update improves overall quality assurance.

Seamless System Integration

Additionally, S!MPATI 4.90 Pharma supports integration into existing laboratory and data management systems. Optional interfaces to modern communication protocols such as OPC-UA, Interbus, and Profibus enable smooth transfer of central data from isolated systems into a networked environment. The software is also compatible with the Active Directory directory service, allowing easy and secure network access. Even during communication network interruptions, the recorded data is not lost thanks to an optional, integrated storage function.

Enhanced Data Security

A key feature of the S!MPATI software is advanced data encryption. Tamper-proof storage and automatic verification ensure that unauthorized changes are immediately detected or made impossible in the first place. The program also ensures traceability (audit trail) of data and processes. Laboratories can document their measurement analyses according to the highest regulatory standards and provide the required evidence at any time. S!MPATI 4.90 Pharma complies with all regulatory requirements, such as FDA 21 CFR Part 11 and EU GMP Annex 11 Next Level Compliance.

Global Availability

The new version of S!MPATI Pharma will be available worldwide from the second half of the year. It offers laboratories a future-proof solution for optimizing reporting, batch evaluation, and compliance.