Pharmaceuticals

Solution overview

• Stability and Shelf Life Analysis
• Root Cause Analysis
• SPC and Quality Control – statistical process control and quality control methods
• Process Optimization
• Statistical analysis – univariate and multivariate methods
• Machine Learning Algorithms
• Product traceability – see the video
• Including tools for building automated, fully configurable reports

The solution is ready for the validation process and includes governance tools such as:

• Role Based Security – managing individual users' access permissions
• Metadata Management
• Versioning/Approving
• Model Management
• Audit Trail
• Electronic Signature Capture

The software's individual features are developed in line with GxP principles, in compliance with international standards and following the recommendations of the FDA (Food and Drug Administration) and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)

Monitoring processes are critical in this industry, which is why the solution also includes the TIBCO Statistica™ Monitoring & Alerting Server, a powerful tool for continuous process monitoring and alarm management.

To address the challenges of manual data entry, the solution also comes with a fully configurable platform for data entry and validation – the TIBCO Statistica™ Data Entry Server.

We are ready to be your reliable partner in implementing the solution and achieving the benefits listed under the “Solution benefits” tab.
You can get in touch with us using the form below.

Solution benefits

• Meeting the requirements of regulatory authorities – FDA, EMA
• Ensuring compliance with international standards – ICH, FDA (FDA 21 CFR Part 11)
• Improving process efficiency

  • –The ability to redefine acceptance criteria for each parameter based on long-term data collection from the manufacturing process, ensuring a robust production process
  • –The ability to acquire and filter data from routine production to estimate the process capability index for each parameter and to document process robustness
• Reduced effort and significant time savings

  • –Automated generation of PQR and CPV reports
  • –Automated generation of user-defined reports
  • –Automated entry and evaluation of manufacturing data
• Lower costs

  • –Timely product recalls
  • –Prevention of future product recalls
  • –Rapid preventive action
  • –Early detection of compliance shortcomings
  • –Avoiding regulatory authority findings
• Reduced risk

  • –Instantly available information on stability trends
  • –Continuous statistical evaluation of trends
  • –Evaluation of correlations between the parameters that affect final product quality
• Faster time to market for products

We are ready to be your reliable partner in implementing the solution and achieving the benefits described above.
You can get in touch with us using the form below.