pi technology can assist your company with the integration of quality into your processes, products and people. To achieve this we provide the following services:
The mission of our specialized validation consultants is to assist you with the validation of processes, qualification of process equipment and laboratory instruments, and validation of computerized systems. Our specialists combine their extensive knowledge of pharmaceutical production processes and their supporting equipment and instruments with an up-to-date knowledge of the current regulations and guidelines. They have extensive validation and qualification experience with all major manufacturing and analytical techniques as well as emerging techniques.
IT application solutions
pi technology delivers solutions customized to your application requirements. Our range of application services includes consultancy, development and implementation. Our consultants bring extensive process design, project management, application and technical experience to every assignment. We can help you assess your challenges and define the best strategies for implementation.
Compared with other industrial sectors such as petrochemicals, there has been a very slow rate of introduction into pharmaceutical industry of modern process design principles, measurement and control technologies, and knowledge management systems. 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. Lean Manufacturing focuses on elimination 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.
The above mentioned quality management techniques are nowadays being combined with Process Analytical Technology (PAT) and Quality by Design (QbD) to improve quality on the shop floor.
Ensuring the highest standards for regulatory compliance and quality systems is essential for any pharmaceutical company today. Increasing competition and potentially decreasing profit margins require the determination of adoption of the correct level of response to regulatory mandates.
This requires a risk-based approach. Our quality minded consultants could either guide you through this process or perform the required activities. Our specific services include a.o.
- the implementation of quality systems
- internal audits
- drafting and submitting of submission files
Companies in the life sciences sector are more and more in need of strategic managements help. Our consultants assist the biggest players in the life sciences industries in all strategic matters; whether that is the construction of a new plant or an upcoming merger. Our consultants determine all the factors involved in these decisions and present the client with an all-encompassing report.
Academy & training
pi technology places a strong emphasis on knowledge transfer. Our specialists are committed to sharing their expertise and best practices with you, not only during their daily work at your site, but also during our high value standard and customized training courses.