The regulation of the pharmaceutical industry imposes strict standards and guidelines for daily operations in an effort to protect the health and safety of those for whom the products are intended. Regulatory groups including the Food and Drug Administration (FDA) dictate protocol, procedures, reporting and more. Adhering to these protocols, while necessary, can be complex and time consuming. So an enterprise wide implementation that embraces these regulations can make compliance with them more bearable. What if a system was in place to continually monitor all stages of the product life cycle, automatically alerting the appropriate personnel when compliance indices fall short? Maintaining compliance is simplified and more successful.
compliance data sheet
- Standard Data and Analysis Templates: Statistica Enterprise provides a platform for data retrieval and analysis templates, ensuring tasks are done timely and consistently.
- Dashboards: Statistica Monitoring and Alerting Server (MAS) provides dashboards to monitor your processes in real time, generate email or other alarm notifications, and generate reports with root-cause analysis results. This allows timely implementation of corrective actions.
- Validated Reporting: Utilizing StatSoft’s Validation Services, the task of validating your analysis tool is greatly simplified.
- Storage, Approval and Archiving of Statistica Documents: The Statistica Document Management System (SDMS) provides an integrated document management system for storage, approval and archiving of data, results, reports, and any documents related to Statistica applications. SDMS is 21 CFR Part 11 compliant. Alternatively, Statistica offers SharePoint integration and also integrates with other document management systems for storage and retrieval of documents.
- Product Traceability: Monitor how materials move through the sequence of steps of a manufacturing process. Easily back in the manufacturing process to view data from each prior step relevant only to the selected product or batch.