With more than 20 years of experience of regulated industries, Elan Software has developed a deep and robust expertise in understanding, analyzing and optimizing manufacturing processes, including the complex processes demanded by personalized medicine. . By embedding GAMP methodologies from the ground-up and providing value-added services, Elan Software offers robust, pre-validated, Life Science-specific solutions and services to translate manufacturing processes into operational excellence effectively and efficiently.
Expertise: our philosophy
The right people to help our customers achieve manufacturing intelligence are people who are used to manufacturing environments - people who have worked in and fully grasp the specifics of Life Science manufacturing and regulation compliance. At Elan Software, all of our consultants and a number of our programming engineers have worked in Life Science industries and know your type of environment well. Twenty years of designing MES systems across all types of regulated industries in many countries has given Elan a wealth of solid experience, which is highly beneficial to all of our customers.
Quality: our culture
It would be nearly impossible to achieve this level of quality for our clients if we were not used to applying the rules to ourselves - to our procedures, software design, development and integration, to our cooperation with our customers, and to all of the work we undertake. Elan Software sells more than products and services. It sells the means to achieve optimal manufacturing quality, every time.
As for Software Development, Elan Software works to GAMP’s V-model Life Cycle (SDLC) Methodology to ensure heightened quality from user requirements to specifications through developments, tests and IQ/OQ qualification.
This methodology is applied to both the development of the XFP software solutions as well as to any customized developments.
Compliance: our watchword
At Elan Software, we offer our customers in-depth specialized knowledge of pharmaceutical manufacturing because over half of our staff is recruited from the pharmaceutical sector. We only build systems for FDA-regulated industry customers, which means that we work to uphold some of the business world’s most closely scrutinized standards. Elan Software is an active member of ISPE and MESA organizations and plays a key role in participating in new GAMP (Good Automated Manufacturing Practice) definitions.