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Sigma in Ukraine provided FormPipe Software with consulting services in creation and establishment of GAMP-compliant Quality Management System, thus ensuring FormPipe Platina increased value for end users in pharm industry.
FormPipe Software is a software company that offers a range of ECM products, including the proficient and highly adaptable platform FormPipe Platina. A track record of several successful projects in pharmaceutical industry and long-term cooperation with FormPipe helped Sigma in Ukraine to win this aspiring assignment. In the end of 2009 FormPipe Software decided to transfer part of works related to QMS creation to Sigma in Ukraine quality managers aiming to prepare for external GAMP certification.
“The Quality Management System was created and established by the joint team of FormPipe Software and Sigma in Ukraine specialists. Three rounds of audits were performed by the auditors from vast pharmaceutical company,” says Vlad Turevsky, Sigma in Ukraine Head or Testing Department and GAMP quality expert. “We are very pleased that our work highly contributed FormPipe to enter pharmaceutical market applying joint efforts of our team and Sigma expertise.”
In October 2010 the Quality Management System for FormPipe Platina successfully passed the final audit, which meant it is compliant to international GAMP 5 standard and FormPipe Software is now able to extend their target audience with pharmaceutical companies. Sigma in Ukraine team is currently involved in further QMS-related works.
“We see Sigma in Ukraine as a strong and competent supplier who has succeeded in delivering solutions for one of our important products. Together with Sigma in Ukraine, we are also developing new markets and new offers to the market,” says Rasmus Staberg, FormPipe Software CTO.
“The fact that Sigma specialists in Ukraine are skilled in GAMP standards is very valuable for us, as pharmaceutical companies are our target customers now. The team with Sigma in Ukraine manages perfectly to work in geographically distributed teams,” continued Rasmus Staberg.
“We are honored to assist our old-standing partner and customer FormPipe Software in such an interesting assignment and are very happy to add value to our services by utilizing our expertise in pharmaceutical standards area,” says Valery Krasovsky, Sigma in Ukraine COO.