RE: software validation Contribution from JD MALLET (continued) written on 9/22/2008 at 18:07
Original contribution: software validation written by Tareq Taha on 9/20/2008 at 23:19) Dear Tareq,
Any software used in production, storage, QC, QA and any activity linked with pharmaceuticals should be validated. However the "GAMP" approach is generally accepted meaning that in-house software are to be considered more in depth than COTS. Concerning your HPLC software you have to ask the vendor for available bibliography on validation of his products and then, develop your protocol on your own parameters.
Answering this Contribution:
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