Process Understanding and Optimization
Video: Multivariate Analysis
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.
How it works
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.
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.
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.
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.
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 theSTATISTICA Enterprise Manager administration software and are stored in a centralSTATISTICA 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) becauseSTATISTICA 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.
GMP Analytic Solutions
Multivariate Analysis, DOE, Simulation, and Data Mining
Manufacturing Intelligence and Customer Portal for Pharmaceutical/BioPharmaceutical Contract Manufacturer
StatSoft’s client is a global leader in the contract manufacturing of active pharmaceutical ingredients, intermediates, and biopharmaceuticals. With sites all around the world, multiple processes running at each site, and many customers—each with its own commitments to regulatory agencies and manufacturing specs for specific products—this complex manufacturer has a uniquely complex set of challenges.
"We found STATISTICA a powerful tool for our needs within our clinical research activities. We chose STATISTICA to perform the critical statistical analysis as it provides a simplistic user interface, high quality graphics and [is] easy to use.
"We highly appreciate the hands on training program provided along with purchase by a representative from StatSoft India which helped us to quickly start using the software and identify the possibilities for our future uses and needs."
— Dr. Sanjay Maroo
Sr. GM of Medico-Marketing
Troikaa Pharmaceuticals Limited
November 20, 2012
"STATISTICA provides a powerful tool...for our QbD approaches and associated cGMP practices. In our opinion STATISTICA is the best software for scientists that are looking for statistical analysis as an essential part of their research...The strong points of STATISTICA are clearly the graphics, vast range of ready to use analysis tab and ease of use.
"Additionally, we want to thank the team StatSoft India as they truly follow through on their commitment to assist the customer's request from the beginning to the end."
— Sarabjit Singh
Vice President - Pharma Research
Panacea Biotec Limited
December 17, 2012
This client relies on the STATISTICA Enterprise software as its global, standard GMP analytics platform to empower its engineers and analysts with role-based access to data, standard analyses, and reports to support process understanding, process monitoring, and regulatory compliance. STATISTICA Enterprise is a key component for this contract manufacturer’s customers to self-service the data and reports about the manufacturing and quality of their respective products.
BioPharmaceutical Manufacturing Process Understanding and Optimization
BioPharmaceutical Manufacturing company was scrapping about 30% of batches, which is incredibly expensive in terms of materials, resources, time, and opportunity costs (for not meeting market demand). The company's engineers tried to solve the problem with various techniques. But it was not until they started using STATISTICA for root cause analysis and predictive analytics (also known as data mining) that they uncovered actionable process improvements. These improvements are predicted to lower the rate of bad batches from 30% to 5%.
StatSoft Makes Computer Systems Validation Easier