Stegmann Systems - Biostatistical Software Solutions

Stegmann Systems provides biostatistical software solutions for the biotechnology and pharmaceutical industries. Our strategic focus is the development of high quality products that meet the current needs for efficient data analysis according to international guidelines. Our software products focus the whole life cycle of assay development (immunoassays and biological assays) and fulfill all regulatory requirements (e.g. 21 CFR Part 11, GAMP). With this concept you achieve maximum flexibility during development stage and maximum security when your assay reaches the production state.

PLA 2.0 - SOFTWARE FOR ANALYZING PARALLEL-LINE AND PARALLEL-LOGISTIC ASSAYS

Immunoassays and biological assays (potency assays) are frequently analyzed with the help of the parallel-line and four or five parameter logistic methods. The complex statistical analysis of these methods requires an advanced software solution which should be easy to learn, flexible and efficient. This is the mission of our software package PLA 2.0.

In contrast to other statistical solutions PLA 2.0 is the only software package that supports all international requirements for assay analysis (e.g. European Pharmacopoeia and US Pharmacopoeia). The application of PLA prevents from using multiple solutions and makes assay development more flexible, faster and cost-effective.

ANALYTICAL FEATURES

Proven statistics for the easy execution of parallel-line and parallel-logistic analytics: PLA implements both parallel-line assays and parallel-logistic assays (4PL and 5PL functions). While the 4PL and 5PL functions describe the whole dose-response curve, parallel-line assays focus the significant part of the dose-response relationship. PLA is able to locate the significant parts of the dose-response curve automatically. There is a full featured range of control options to determine the optimal assay configuration.

Studentized residuals method, Dixon test, Grubb's test and a test based on the standard deviation are available to exclude outliers from the analysis. An optional equivalence test based on the ratio or difference of slopes is available as an alternative approach for parallelism testing. PLA is able to calculate weighted and un-weighted combinations of independent assay results.

DATA EXPLORATION AND MANAGEMENT

Explore your assay data directly on the screen and apply different analytical methods on-the-fly. Assay data are organized in databases for fast and secure access. Set up any number of databases and share your data across the network.

You can benefit from perfect and secure reporting including high quality graphics. The analysis reports are created as secured Adobe PDF™ files. Report templates for Microsoft Word™ and Excel™ are also available.

FIT FOR THE ENTERPRISE

In accordance with the FDA 21 CFR part 11, PLA has its own security infrastructure that requires users to log into the system. User accounts and their roles are defined with an easy-to-use interface and are database specific.

Electronic signatures can be applied to PLA's records. With PLA advanced data storage technology electronic signatures can even be moved between different installations of PLA (e.g. to/from your CRO). PLA has its own audit trail that covers all changes of data and properties of your assay and of all security features inside PLA.

INTEGRATION FEATURES

PLA has a full set of interfaces for the import of raw data from data acquisition systems, for the export of assay data to e.g. documentation systems and for reporting into many target systems (e.g. Adobe PDF™, Microsoft Excel™, Microsoft Word™, OpenDocument).

The optional validation package helps you to manage the tasks of installation qualification, operational qualification and performance qualification (IQ, OQ, PQ) fast and efficiently.

Free technical and scientific support is available from Stegmann Systems.