Pharma 4.0 has been called a new industrial revolution as its implementation will more likely resemble an evolution in which digitization and automation meet a very complex product portfolio with long life-cycles.
We at Faststream achieve a common understanding of readiness and maturity, starting with enablers and components defined in the International Conference on Harmonization(ICH) Q10.The Pharmaceutical Quality System along the product life cycle. We have developed business cases to showcase industry 4.0 automation and digitalization technologies can be applied to pharma and implications we are facing due to the current regulatory challenges we have in the pharma industry.
Digitization, an important component of Faststream, will connect everything, creating new levels of transparency and speed for a digitalized plant floor. This will enable faster decision-making, and provide in-line and in-time control over business, operations, and quality. It will also require higher levels of security, since connected systems heighten vulnerability.
Perks of our Solutions
Innovation technology – upfront & visible.
Getting the data and controlling the process under its command, is only one side of the coin. Integrating with Manufacturing Execution & Business Systems through efficient interfaces continues the ergonomic nature of Faststream.
Command & Control with ERP & MES interfaces
Integrate production and critical process information into the business layer.
Ergonomics drives performance
Communication drivers allow integration to many different systems without the need for any changes or additions to the 3rd party system.
Vertical integration to higher level systems bridge control structures into senior operations and business IT, e.g. through native SAP interface.
Compliance to international regulations such as the FDA 21 CFR Part 11 with electronic records and signatures.
Full documentation and versioning of Batch recipes and RGM (Recipe Group Manager) recipes.
Full production documentation, recording events, critical process values, RBE, and regulatory compliance.
Parameterization brings flexible integral functionality to life in a regulated GMP environment, making validation as efficient as possible.
Project history, project comparison and automated documentation, highlight the changes, risk and quality implications with project evolution and development.
Linking business and production with live, real-time and accurate results, benefits decision making with accurate data. Closed-loop application of initiatives which enhance quality, performance and energy efficiency.
Create individual and ergonomic production control environments, in the local language and measurement units. Through transparency the operator can view machine status and alarms across the production line or facility, without the need to visit each machine.
Intuitive interfaces provide intelligent user interaction and optimized presentation of processes. The use of Multi-Touch applications will increase usability and operating safety.
Cross-system dashboards and reporting visualizes your enterprise, enabling you to see optimization potential.
Lift machines into processes, with process-wide analysis, audit-trail, and alarm management. Analyze, compare and report across all systems. Focus the data to individual needs, and get information in real time. Implement ISO 50001 compliance to reduce energy consumption.