Pharmaceutical Information System/Technology(PIS)

Each stage of IT implementation in the pharmaceutical area is driving toward enhancing processing efficiency, improving results, adding more values, adding more validations, ease of systems adoption and much more. At every stage of drug discovery, development and delivery are innovative technologies key to assisting regulatory compliance issues and organization optimization.

The next generation Pharmaceutical IS is designed to aid the following:

  • Compliance and Regulatory issues (FDA / GAMP)
  • Standardization
  • Manufacturing Execution Systems
  • Process Control and Automation
  • IT Platform Integration
  • Content and Document Management
  • Grid Computing

  • Role of IS/IT in Biopharmaceutical Process Development:

    • Bioprocess is a very complex operation that demands many significant information measurements. Information technology solutions such as laboratory information management systems (LIMS) programs have been adapted to capture real time data, as in Process Analytical Technology (PAT) applications. It now appears that information technology solutions will play a major part in confirming—by experimental and statistical validation—that bioprocesses may be interchangeable and therefore generic.

  • What IS/IT can do for Biopharmaceutical:

    • Bluetooth in sterile suites
    • Electronic logging devices
    • Electronic data capture in bio processing’s tight current good manufacturing practice (CGMP) spaces
    • Ensuring a generic product
    • Computerized maintenance management systems (CMMS) can integrate process management with equipment control

    Sakthi can build any software applications for pharmaceutical and its related industries which will be easy to use using latest technologies and methodologies. Sakthi is also helps clients ease of data capture electronically, real time report generation, and third party system support. Sakthi can help in the above areas as well as following general software services for the pharmaceutical area:

    • Signature authentication
    • Business Case Assessment
    • System integration
    • Software development and test support for new innovative pharmaceutical products
    • Wireless software customization and hardware setup and maintenance
    • Third party software maintenance and support
    • Software testing and performance analysis
    • IT staffing including temporary and/or permanent resources placements
    • Project Management
    • Training
    • Support and Maintenance

    • At the end, Sakthi customers gain the following values:

    • Optimize your IT spending
    • Eliminate, reduce or simplify unnecessary IT/IS complexity
    • Organizing IT function to keep pace with business change
    • Managing and simplifying security, risk and compliance issues
    • Applying best practices specific problem
    • Improve performance