Biopharmaceutical Manufacturing Data Sheet
The Pharmaceutical Manufacturing industry aims to ensure that the medications they create not only meet the intended use of that medication, but also that it is safe for those taking the medication. GxP quality guidelines were developed so that manufacturers in this regulated industry achieve this aim. GxP requirements mandate that pharmaceutical companies utilize software that meets specific industry requirements. By law, the software must have secure logging for users and activities, keep archives of relevant information for a specified time frame, provide for accountability of tracked data, insure that audited information is genuine, document the decisions that lead from product requirements to business decisions and be able to provide subpoenaed documentation. With this list of critical needs, a software package is needed that is comprehensive and easy to validate in any environment.
The Statistica Pharmaceutical Solution for the Manufacturing industry provides a platform that will provide 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. The solution is configured as a key component for pharmaceutical and/or biopharmaceutical research and development, and manufacturing activities so that industry experts will have immediate access to the data and reports about the manufacturing and quality of the products under their responsibility. The 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 because Statistica is COTS software that requires little if any custom coding or scripts, provides ease of validation and deployment, and restriction of validation tasks to the intended uses of the system.
- Batch or Real-Time Processing: Use the models you have built to make predictions, either by batch or in real-time.
- Cutting-edge Predictive Analytics: Statistica provides a wide variety of high-performance, award-winning, sophisticated algorithms to build models which provide the most lift and highest accuracy.
- Innovative Data Pre-processing Tools: Statistica provides a very comprehensive list of data management and data visualization tools.
- Integrated Workflow: Statistica Decisioning Platform provides a streamlined workflow for powerful, rules-based, predictive analytics where business rules and industry regulations are used in conjunction with advanced analytics to build the best models.
- Optimized Results: Compare the latest data mining algorithms side-by-side to determine which models provide the most gain.
- Role-Based, Enterprise-Wide Scope: In a multi-user collaborative environment, you can use Statistica Enterprise to share data, improve models, and benefit from a collaborative work group.
- Roles and responsibilities are easily managed using the existing infrastructure of domain and directory accounts so that users electronically sign in using their standard network account username and password.
- The platform includes configured connections to data repositories, empowering 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.
- 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.
- Key stakeholders are empowered with self-service report summaries about respective products and processes via a Web-based portal configured in Statistica Enterprise.
- Configuration of the queries, analyses, reports, and dashboards are managed in Statistica Enterprise and are stored in a central Statistica database deployed on a standard relational database management system.
- Text Mining of Unstructured Data: Improve models by leveraging your unstructured data through powerful text mining algorithms.
- Stability and Shelf Life Analysis: A validated solution which has been installed and successfully utilized at some of the largest manufacturing facilities in the world. This solution successfully integrates enterprise-wide role-based security, predefined data configurations and analysis configurations, customizable reporting and flexible analytical tools to handle any analysis requirement. All analyses follow ICH and U.S. FDA guidelines, meeting the stringent requirements established by these organizations.
"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