BRAINE-L'ALLEUD
À propos de pi ≥ excellence
pi ≥ excellence
pi is a global integrator of excellence to some of the world’s leading life science companies. From our origins as a trusted supplier of regulatory and technical support we’ve grown to become their strategic partner of choice.
We’ve grown to be bigger by learning how to be better. Better resourced to focus our faculty of practitioners’ singular experience and knowledge. And better managed to share their depth of understanding. Better prepared to challenge orthodox thinking. And better able to redefine accepted best practice.
To accept no other standard than excellence.
OUR CORE BUSINESS
Six Sigma and Lean Manufacturing
In recent years leading pharmaceutical manufacturers began to adopt proven best practice methodologies such as Six Sigma and Lean Manufacturing. Six Sigma provides a disciplined method and tools (including statistical) for eliminating errors in a process. The most widely recognized Six Sigma tool is DMAIC.
Lean Manufacturing focuses on eliminating waste and developing better work management methods which are a cornerstone to an efficient business. Lean defines seven types of waste: overproduction, inventory, rework/rejects, motion, processing, waiting and transport.
Process Analytical Technology
The above mentioned quality management techniques are nowadays being combined with new Process Analytical Technology (PAT) to improve quality on the factory floor. pi has developed its own strategy to integrate Process Analytical Technology with the more commonly known quality management techniques like Six Sigma and Lean Manufacturing.From the beginning on pi has strived to become a PAT-integration specialist with a variety of projects at several customers. As an integrated solution provider pi is very strong in building relationships with other PAT-partners to find the right custom-build solution for your processes. This approach gives you the flexibility to build customized solutions without being dependant on one or more PAT-application vendors. This gives your company the benefit of being able to choose from a wide range of PAT-applications. Our specialized consultants will help you to integrate these applications into your company. To achieve this pi has developed its own roadmap towards PAT-deployment that can easily be applied to your company. Together with this roadmap we have developed several tools to help you with PAT-integration or to assess the qualified state of your PAT-applications.
Process Validation
Support in the development of processes using an integrated approach
Identification of the Critical Control Parameters
Execution of Risk and Criticality Analysis
Process optimization
Development and execution of Process Validation Protocols
Development of Validation Summary Reports
Impact Analysis on existing processes to support Change Control
Support in Technology Transfer
Process Equipment and Laboratory Instrument Qualification
Development of your Validation Master Plans
Risk Management to define the extent of qualification and identify potential gaps
Development of procedural controls to mitigate identified gaps
Development of User Requirement Specifications
Support with Commissioning and Risk-based commissioning
Development and execution of Qualification Plans and Protocols (DQ/IQ/OQ/PQ)
Development of Validation Summary Reports
Support in setting up maintenance and calibration programs
Support in Periodic maintenance and Re-qualification schedules
Support in the Change control process
Support in Decommissioning and Retirement
Computerized System Validation
Validation of Computerized Systems, including hardware and software (see process equipment and laboratory instruments)
Conduction of supplier audits
Software compliance assessments (21 CFR Part 11 and EU Annex 11)
Compliance impact assessments of software upgrades
Development of electronic data back-up strategies
For further information, please visit the website:Array
