AT A GLANCE

Ensure product safety, quality, and regulatory compliance for pharmaceutical, medical device, food, and regulated manufacturing environments. With TIBCO Statistica™, you can easily combine and analyze the most up-todate data from disparate systems and associated data sources. This powerful analytics solution minimizes risk by making it simple to rapidly detect emerging issues and take corrective actions. Plus, it satisfies the most stringent regulations by providing a secure and validated analytics environment, while delivering auditable workflows and reports for regulated manufacturing.
With Statistica, you can feel confident that you’re meeting the highest standards for product safety, quality, and regulatory compliance.

#thedatashack

TIBCO Statistica can help you

COMPLY WITH FDA AND ICH GUIDELINES Minimize the amount of time and paperwork required to demonstrate regulatory compliance for your analytics and reporting platform.
RAPIDLY DETECT MANUFACTURING ISSUES Reduce scrap, rework, and quality issues with advanced quality-control analytics, root-cause analysis, and validated reports.
DELIVER ACCURATE DATA TO CUSTOMERS AND SUPPLIERS Access the latest information to better understand product manufacturing via secure web portals.
EMPOWER ENGINEERS AND PROCESS EXPERTS Provide teams with flexible tools to proactively identify and resolve emerging issues
MANAGE MATERIALS SOURCING VARIABILITY Increase supply chain visibility, both upstream and downstream, to better track the sourcing of ingredients
OPTIMIZE PROCESSES Identify and resolve bottlenecks, improve supply chain processes, and more

Features

ACHIEVE REGULATORY COMPLIANCE Gain a fully configurable, secure, and auditable analytics platform that’s compliant with major regulations, including FDA 21 CFR Part 11, Sarbanes-Oxley, and ISO 9000, 9001, and 14001.
PRODUCT TRACEABILITY Easily review the movement of materials and batches through complex sequences of unit operations—including interactions between upstream and downstream processing, raw materials, media, and instrumentation—so you can perform meaningful qc-charting, reporting, root-cause analysis, and more.
STABILITY AND SHELF-LIFE ANALYSIS Ensure toxicological, microbiological, physical, and chemical stability, and shelf-life analytics methodologies meet technical requirements and regulations set forth by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) and the US Food and Drug Administration.
STANDARDIZED COMPLIANT DELIVERABLES Document and validate user requirements, functional specifications, validation plans, test plans, and other processes.
BUILT-IN AUDIT TRAIL WITH ROLLBACK Maintain a record of all changes; gain the ability to quickly revert to the previous state if something was overlooked.
QUALITY CONTROL, SPC, AND SIX SIGMA Use a comprehensive toolset for statistical process control (SPC), process optimization, and quality imperatives, including design of experiments to improve production quality for complex manufacturing processes.
MONITORING AND ALERTING Centralize and automate the continuous monitoring of processes and product parameters. SELF-SERVICE CUSTOMER PORTAL Monitor manufacturing parameters through a secure and configurable web portal.
VALIDATED WEB DATA ENTRY Easily configure data entry scenarios with double-blind validation for field personnel who need to manually input data. Setup workflows to automatically integrate with your enterprise systems.
REAL-TIME SCORING Implement real-time predictive analytics within your manufacturing environment to proactively detect issues before they become problematic.