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Pharmaceutical Compliance with TIBCO Statistica®

Last updated:
12:33pm Apr 03, 2020

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?  

  • Companies need the latest information about the manufacture of their products.
  • Data is in disparate databases requiring data connections, aggregation, and alignment across data historians, LIMS, SAP, etc. Data integrity is critical for the validation process. Data lineage needs to be transparent and watermarked / protected.  
  • At each manufacturing site, a complex assortment of products are being manufactured for a wide variety of markets.
  • The yields and quality are examined with a high degree of scrutiny. Optimization is a challenge.
  • Engineers need access to the latest continuous and discrete data to identify and troubleshoot any issues.
  • Variability in the sourcing of ingredients and media impact the processes
  • Compliance with ICH guidelines and reporting standards are universal requirements requiring validated tools and processes

Statistica products for this solution include the following. 

Statistica Server is an analytic job server with a metadata store that centrally manages database connections, queries, analysis templates, report templates, workspaces. Items can be versioned, approved and shared via roles-based security.

Data can be cleaned and via an approval process, audit trial and annotations the data can be watermarked / approved for use.

Statistica Data Entry Server enables pharmaceutical companies to configure data entry scenarios for each unit operation of their processes, with integrated workflow/approvals and analytics. 

Multivariate statistical process control 

(MSPC)  analytics, designed for process monitoring and predicting quality outcomes.

Statistica PI Connector allows for direct integration with data stored in the PI data historian, used for streamlined and automated analyses for applications such as Process Analytical Technology (PAT).

Product traceability is a solution for mapping complex (batch) processes to meaningful analytic reporting and drill-down. Integrate with virtually all LIMS and similar systems to enable meaningful reporting and root-cause analyses over selected process steps, providing a flexible, high-dimensional view into the automated manufacturing process.

Statistica stability and shelf life analysis is a complete solution for validated shelf life analysis and reporting. The solution implements accepted standard approaches for single and multiple batch studies, pooled and separated per-batch esitimation (separate intercept, separate/common slope, poolability tests), and all common procedures for shelf life estimation.