PLA 3.0

Current Status: On sale, Supported
Latest Version: PLA 3.0.4 SR6 (build 762) 2018/09/28 / Biological Assay Package 26 SR1 (build 1043) 2019/05/17

Lifecycle
End of Life (Support) 15 March 2024
End of Sales 15 March 2021
Release Date 15 March 2014
Free Trial of PLA 3.0 available

You can download a fully functional version of PLA 3.0 and try it out free of charge for 14 days.

Note

If you purchased PLA 2.1 or any earlier version of PLA and your PLA Support Contract is still active, you may upgrade to PLA 3.0 for free. Your license keys have already been generated. Simply download PLA 3.0, install it and download your license keys.

Feature Overview

PLA 3.0 Feature Overview

Download

Product Overview  Data Sheet

 

About PLA 3.0

Discover the Next Generation of Bioassay Analysis

PLA 3.0 has been released 2014 as a successor of the PLA 2.x platform. PLA is now an extensible platform for any biostatistical analysis method fit for R&D and regulated environments.

All Assay Types Described in Ph. Eur. and USP in One Single Software

PLA 3.0 supports all types of biological assays according to European Pharmacopoeia Chapter 5.3 and US Pharmacopeia <111> ,<1032>, <1033>, <1034>: Quantitative Response Assays (Parallel-Line, Parallel-Logistics, Slope-Ratio) and Dichotomous Assays (Quantal Response, Binary Assays). PLA 3.0 also supports all different weighting methods for combination calculations and the automatic data aggregation of independent assay data. Additional document types are available for Equivalence Margin Development, Control Charts and a Basic Bioassay Protocol.

Building an Assay Archive for Later Review

Over the months and years, you will spend considerable amounts of time and money on your assays. With PLA 3.0, you make sure that all your assays remain accessible for later review. PLA 3.0 keeps them in a database, ready to be retrieved with just a few clicks.

FDA Compliant, User-friendly Platform

Compliance with FDA 21 CFR Part 11 is one of the most important requirements for  software meant for regulated environments. The challenge is to make the software  fully compliant at the core and user-friendly on the surface. With PLA 3.0, we managed to achieve exactly that.

Ready to Integrate With What You Already Use

PLA 3.0 is a highly versatile platform, ready to be extended to suit your particular needs. We developed a number of modules that allow you to connect PLA 3.0 to other programs or equipment, such as plate readers. In effect, your bioassay analysis will be independent of the device you are using to acquire the measurement values.

Covering the entire lifecycle

In order to use software in companies or teams of different sizes, it should be easily extensible and scaleable. We therefore built several features into PLA 3.0 that make it not just suitable but in fact ideal for projects and teams of virtually any size.

Templates

PLA 3.0 comes with a new template engine. Templates can be defined by authorized users. They decide about the visibility, access level and default values in a document. Templates can be signed electronically and the administrator can define the mandatory use of specific templates in the database or in database sections. The template engine was designed to support the easy implementation of standard operating procedures (SOPs) within PLA.

Validation and GxP Compliance

According to GAMP software has to be validated on the customer’s computer system. The software vendor is only able to verify the software in his labs. The optional Validation Package helps you to manage the tasks of installation qualification, operational qualification and performance qualification (IQ, OQ, PQ) fast and efficiently.

Integration

PLA has a full set of interfaces for the import of raw data from data acquisition systems, for the export of data to e.g. documentation systems  and for the reporting into many target systems. Individual modules can be created at low cost.
Import Modules are now distinguished into Document Import Modules creating a complete document with all settings and Data Acquisition Modules. Data Acquisition Modules are able to import data into the data table of any document type. (Note: They replace the former PLA 2.x Import Modules.)

Document Import Modules generate fully specified documents of a specific type. They are useful when an external format contains every information required to create a specific document. E.g. if a third party program deals with biological assays a Document Import Module can be set up in a way where a completely specified quantitative response assay is delivered. In this case the Document Import Module converts all settings and creates the appropriate PLA 3.0 document. Read more ...

Data Acquisition Modules are used to connect external systems directly to the data tables of a PLA 3.0 document. Typical examples are Data Acquisition Modules for plate readers. A plate reader delivers a stream of measurement values that need to be imported to the data table of a specific document in a GLP/GMP compliant way. Data Acquisition Modules are the most common import modules used by PLA. Currently, we have more than 40 different Data Acquisition modules available.Data Acquisition Modules are licensed by the supported external format. They are not specific to the target document type. Read more ...

Export Modules are available to export PLA 3.0 Document to a specific External Format. They export the PLA 3.0 Document and transform them into the target format. They can be used to connect PLA to other external systems (e.g. LIMS systems). Read more ...

Transfer of Data and Templates

PLA allows to transfer data and templates between projects, sites and companies in a secure manner. The trustability and integrity of the data is assured by a combination of electronic signatures, that are preserved in the transfer,  and cryptographically secured data transfers. PLA secures the information with the help of its own integrated PKI (Public Key Infrastructure).  This operation is completely transparent for the user. It assures the secure communication of data and templates to different projects, sites or CROs.

Roles and Permissions

PLA 3.0 comes with an updated sophisticated permission system scalable from single seat to global installations. Typical roles are predefined in the system but can be altered to match your companies needs. All the settings are combined together in named security contexts that can easily be applied to new folders.