Planning, Design, Documentation and Maintenance of Pharmaceutical and Life Sciences Plants.
In the pharmaceutical and bio-technological industries, the regulatory requirements for plant documents are particularly high. The time and personnel efforts required for creating these documents are equally intensive. In order to minimize the project duration and effectively adapt to project modifications, CADISON is an efficient tool not only for design and engineering but also for creating qualification and plant documentation as per their customer standards.
More and more customers are using fast-track-projects in the pharmaceutical and biopharmaceutical industries, where tight schedule must be adhered to with pressing deadlines. In order to meet complex requirements in less time and without errors, one needs a reliable database and an integrated data system. Thus, CADISON is the platform for creating and managing documents (concept creation, development, design, procurement, assembly, start-up documentation, qualification, validation documentation and transmission of documents to the customers) which entirely enables all aspects of project management with higher quality.
The designer saves resources, time, and cost and improves the quality..
Even after delivery, the documentation is required for maintenance service and expansions and needs to be maintained. With CADISON all the documents remains up-to-date over the entire life-cycle.. The regulatory requirements for quality and documentation management in the pharmaceutical Industry are increasingly harmonized at international level (for e.g. FDA, EMEA, etc.) and with that converted to national guidelines. Important regulations are for e.g.
- ISPE guidelines for Good Engineering Practice (GEP) as well as commissioning & qualification
- STM E2500 (Standard guide for specifications, design and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipments
- ICH-Q10 for GMP compliance
- ASME BPE-2009 Bioprocess Equipment
Our solutions offer you design and installation of clean-in-place (CIP) systems often in constrained locations of facilities to help achieve effective and easily validated cleaning methods thereby assisting FDA inspections of cleaning processes.