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Documentation A full engineering turn-over package (ETOP) is supplied with every Pod. Modules are manufactured and delivered with full documentation and an FAT can be performed prior to delivery. IQ/OQ of major capital equipment can be provided in most cases to the customer before delivery saving months of commissioning time over conventional modular installation. IT and Management Services G-Con Pods are equipped with management systems that provide a constant data flow of environment performance, a requisite for cGMP compliance. Temperatures, pressures, HVAC rotation, etc. are all monitored and reported to the data management system. Pods are IP addressable with their own hub and switch and can be monitored from an internet connection over a secure interface. Pods are pre-wired for any custom need. Design, Engineering and Validation Services G-Con also provides design services for companies and institutions building biotherapeutic manufacturing facilities. G-Con's staff has designed and supervised construction, as well as commissioned cGMP compliant facilities and can assist companies whether it is their first or tenth facility. G-Con's QA staff can design quality assurance systems, facility validation master plans and process validation master plans. |
 G-Con's team members have worked with large pharma and biotech companies to design, build and bring facilities into compliance. G-Con's team has also successfully designed systems for manufacture of patient specific medicines and cancer vaccines. |
