PQE Group can support your business, focusing on your product's quality.
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2 - Real-Time Context: from Life to Business and Vice-versa
We live in a real-time era. The ability to be connected anytime, anywhere, by sharing activities and receiving immediate notification, has provided the opportunity to access information in real-time.
Whether this innovation in personal spheres can decrease life balance by affecting critical privacy management, pharmaceutical companies can significantly increase process efficiency and product quality, optimize and accelerate responses, speed to market and patient safety and life quality expectations.
AVEVA PI is a real-time milestone within the context of data management solutions. Moreover, the implementation and maintenance of its validated status as a computerized system ensures compliance with GxP requirements in a continuous manner.
PI modules have been designed to collect and store data in real-time from different systems generating time-based data as Process Control Systems (PCS), Program Logic Control (PLC), Supervisory Control and Data Acquisition (SCADA), Building Automation Systems (BAS) and Distributed Control Systems (DCS). Data scientists, IT departments and the operations companies involved in the different steps of drug or product life cycles can take advantage of AVEVA PI in terms of faster and more reliable achievements of critical technical operations.
3 - Prediction as Cost and Time Consumption Solutions
Knowing the critical points of an event allows users to limit their occurrences
AVEVA PI components allow users to collect and contextualize each framework of a defined process event (e.g., the temperature parameter of equipment during the operation phase); therefore the build of the process allows users to identify and predict the flow of a specific event by reducing the cost and time required for the problem solving. The prediction feature of AVEVA PI is a major challenge for the business process.
In particular, the monitoring of process variations and the related statistical analysis are provided to create modelling methods. These models can be used to estimate future event trajectories in terms of parameters or final conditions of batch type processes.
4 - Business and Quality Benefits of a Validated AVEVA PI System
We consider Quality in terms of data trustworthiness and reliability, Business as process monitoring to increase efficiencies, and Future as advanced planning of events as the three major Values of AVEVA PI.
Companies operating in a regulated environment such as pharmaceuticals are appropriate users of AVEVA PI benefits. In particular, the state of control of a validated computer system ensures the proper management and security of data as well as drug and patient safety during the entire software life cycle.
The FDA defines process validation as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes."
Validation is a process that requires time and effort in order to ensure compliance as a GxP computerized system.
PQE Group’s combined knowledge has enabled us to design accurate and lean Validation approaches, following customer needs with respect to the applicable regulations.
PQE Group has worked in the following areas around the world, managing projects at a global level: Belgio (Lessines), Spagna (Tres Cantos), Italia (Pisa, Rieti), Austria (Linz, Orth), Irlanda (Bray, Grange Castle), Germania, Norvegia (Asker), Singapore, Stati Uniti (Brooklyn Park, Lexington), Inghilterra (Cambridge).
References
- ISPE Forum GAMP5: A Risk-Based Approach to Compliant GxP Computerized System
- www.osisoft.com
- EudraLex, Annex 11: Computerised System
- US FDA 21 CFR Part 11 and Guidance for Industry - Part 11, Electronic Records; Electronic Signatures - Scope and Application
