Pharmaceutical Manufacturing

The STATISTICA Enterprise software is the global standard GxP analytics platform for empowering engineers, analysts, operators, scientists, managers, and customers with role-based access to data, standard analyses, and reports in order to support process understanding, process monitoring, and regulatory compliance. STATISTICA Enterprise is configured as a key component for pharmaceutical/biopharmaceutical research & development and manufacturing companies’ activities so that knowledge workers have immediate and proactive access to the data and reports about the manufacturing and quality of their respective products.

STATISTICA Solution

User Interface: Engineers and analysts at each site are presented with a user interface that matches what they know: the processes! On the STATISTICA Enterprise screen, they see and interact with the respective unit operations and parameters from the processes.

User/Group Security: Personnel at the sites have different roles and responsibilities: Operators enter data. Managers review summary reports. Engineers monitor real-time auto-updating trends of the current batches. In STATISTICA Enterprise, roles and responsibilities are easily managed using the existing infrastructure of domain and directory accounts so that users log on and electronically sign in using their standard network account username and password.

Data Connections: A primary benefit of the STATISTICA Enterprise server platform is its configured connections to data repositories. In pharmaceutical/biopharmaceutical manufacturing, there are many systems and sources of data, but engineers need the relevant data to investigate an issue immediately. STATISTICA Enterprise empowers users by managing the connections to relevant data sources centrally on the server so that engineers and analysts have point-and-click access to the data they need when they need it.

Analysis Templates: In STATISTICA Enterprise, standard analyses are defined and configured as analysis templates and are made available to the large numbers of other personnel who have responsibility for monitoring and decision making for the respective products and processes.

Report Templates: Organized, formatted report summaries (PDF, MS Word, HTML) are integral to keeping people informed. Key stakeholders are empowered with self-service report summaries about respective products and processes via a Web-based portal configured in STATISTICA Enterprise.

Central Configuration and Management across a Site or Site(s): Configurations of the queries, analyses, reports, and dashboards are managed via the STATISTICA Enterprise Manager administration software and are stored in a central STATISTICA database deployed on a standard relational database management system.

Computer Systems Validation: STATISTICA Enterprise software is easy to validate, with built-in features such as user access control and security, audit trails, and PDF reports to streamline validation. StatSoft’s stature has grown dramatically as a major global provider of analytics software: 1) because STATISTICA is COTS software that requires little if any custom coding or scripts, and 2) due to the ease of validation and deployment as well as the restriction of validation tasks to the intended uses of the system.

User Experience and Ease of Use: STATISTICA Enterprise provides personalized portals to the relevant information, making it easy to use and navigate, so knowledge workers focus on making informed decisions based on alerts and exceptions versus a tedious manual review of each and every report generated, resulting in dramatically reduced manpower and advanced early detection of new trends or shifts.

Automated Alerts: Proactive, automated alerts enable knowledge workers to become aware of shifts, trends, and patterns immediately so they can take action and drill down into the details directly from the report or dashboard.

Report Templates and Report Generation: Many stakeholders need to be provided with self-service options for maintaining awareness of the status of processes, such as standard formatted reports. The STATISTICA Enterprise system automates this process.

Customer Portals: For contract manufacturing, STATISTICA Enterprise provides a secure, standard approach for configuring the different views of data required by each customer. Customers can have access to self-service portals and obtain standard reports to minimize the resources and costs involved in supporting customers’ requests for data and status updates.

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About statsoftsa

StatSoft, Inc. was founded in 1984 and is now one of the largest global providers of analytic software worldwide. StatSoft is also the largest manufacturer of enterprise-wide quality control and improvement software systems in the world, and the only company capable of supporting its QC products worldwide, with wholly owned subsidiaries in all major markets (StatSoft has 23 full-service offices, on all continents), and its software is available in more than 10 languages.

Posted on August 14, 2013, in Uncategorized. Bookmark the permalink. Leave a comment.

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