Regulatory Open Forum

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  • 1.  LIMS vendor suggestion

    Posted 16-Apr-2018 11:28
    Hi all,

    We're a start up for stem cell manufacturing. We are currently looking for a LIMS vendor, any suggestion? Thank you!

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    An Dao
    Regulatory Affairs Manager
    Houston, TX
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  • 2.  RE: LIMS vendor suggestion

    Posted 18-Apr-2018 00:37
    Hi An,

    STEMSOFT provides data management for cellular therapy manufacturing, apheresis collection and clinical patient administration. I am currently working as a consultant for STEMSOFT and helping them to translate clients' SOPs into workflows and configurations that match the practice. Data entry is in real time and the system tracks manufacturing, consumables and equipment as well as places and institutions and can alos generate label (ISBT 128 compliant or custom). The software can interface with other devices and EHR systems and there is also an option to link into systems such as an eQMS and document management software. My particular interests are quality and regulatory so I am also ensuring that the system allows for compliance to GMP, GTP, FACT and/or AABB regs and standards as applicable to the business as well as the creation of quality reports, validation and compliance documents. I'd be happy to chat with you or introduce you to Nicole Waidman, who would be able to give you a demo and tell you about the Jump Start program that I initiated.

    Feel free to connect with me on LinkedIn where there's a little bit about my lab background.

    Thanks so much,
    Debe


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    Deborah Griffin MSc, ASQ CPGP
    Consultant, Quality Management and Regulatory Affairs for Cellular Therapy
    Seattle, Washington
    United States
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