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Hi all, We're a start up for stem cell manufacturing. We are currently looking for a LIMS vendor, any suggestion? Thank you! ------------------------------ An Dao Regulatory Affairs Manager Houston, TX ------------------------------

Thank you Victor and Michael for the advice. Sorry that I was not able to reply earlier due to the flooding. All is good now, the water receded and then I have a clear plan for validation of the aliquot and qualification of the vendor once I'm back in office :). ------------------------------ An ...

Hello all, I have a question regarding aliquot validation (not sure if it is needed) for the raw materials. We purchased raw materials from qualified vendors such as sterile water, media, PBS.... and obtained certificate of analysis with endotoxin, sterility and sometimes mycoplasma. Since we need ...

Hi all, We are a small company located in Houston, Texas with a GMP suite. We're looking for a vendor ( will be a great bonus if the vendor is local) to do facility qualification. Any recommendations? Thanks a lot! ------------------------------ An Dao Regulatory Affairs Manager Houston, TX ...

Thank you all very much for your feedbacks :). Y'all are awesome. You guys have been so instrumental throughout my regulatory career since the first day I joined and took the first lesson of the RAPS certificate. I don't post a lot but I do follow all the discussions and these posts have been very helpful. ...