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  • Dear Colleague, Personally, I would describe the management of clinical evaluation report (CER) in an SOP. Not all reviews mean update. I might be concluded, that no information is available, that would prompt update. But I would document clearly the fact, that CER has been reviewed or updated, when and why. What ...

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    RE: Cleaning agent

    Brenda, Cleaning and sterilization (killing bacteria, fungi or spores) should be distinguished for validation purposes. As for cleaning validation, it is worth reading FDA info on the issue at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124777.htm Thank you. ...

  • Try to get in touch with sales person from Steris. https://www.steris.com/ They will advise you the best disinfectant based on your needs either bactericidal, fungicidal, sporocidal, etc. The products are labelled with the usage direction. ------------------------------ Gaurang Bhavsar Edison NJ United States -----------------------------

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