{"id":62,"date":"2017-08-25T18:18:22","date_gmt":"2017-08-25T18:18:22","guid":{"rendered":"http:\/\/csg.tommymccullough.com\/?page_id=62"},"modified":"2017-08-25T21:24:31","modified_gmt":"2017-08-25T21:24:31","slug":"verification-validation","status":"publish","type":"page","link":"http:\/\/csg.tommymccullough.com\/?page_id=62","title":{"rendered":"Verification & Validation"},"content":{"rendered":"
\t\t\t
    \n
  • Philosophy\n
      \n
    • Represent the best interest of our clients<\/li>\n
    • Involve QA Early<\/li>\n
    • Work as if we are our client’s employees<\/li>\n<\/ul>\n<\/li>\n
    • Approach\n
        \n
      • Establish consensus of requirements early, repeat them<\/li>\n
      • Communicate, small issues will grow<\/li>\n
      • Define roles and responsibilities early, repeat them<\/li>\n
      • Realize that ownership during project lifecycle will change, global engineering to plant engineering to operations. Understand the transition and respond to their needs.<\/li>\n
      • Minimize reviewers and approvers<\/li>\n
      • Who can authorize changes?<\/li>\n<\/ul>\n<\/li>\n
      • Services\n
          \n
        • ASTM E2500 Implementation<\/li>\n
        • Master Planning<\/li>\n
        • Project Management<\/li>\n
        • SOP Preparation<\/li>\n
        • Project Staff Augmentation<\/li>\n
        • Boundary Drawing Preparation<\/li>\n
        • Change Control<\/li>\n
        • Protocol Preparation, Execution and Summary Reporting\n
            \n
          • Utilities Testing (direct and indirect impact)<\/li>\n
          • Tablet and Encapsulation Machine Qualification<\/li>\n
          • Process and Filling Systems Qualification<\/li>\n
          • Packaging Equipment Qualification<\/li>\n
          • Sterilization Equipment Qualification<\/li>\n
          • Sterilization Equipment Qualification & Cycle Validation<\/li>\n
          • Lyophilization Equipment Verification & validation<\/li>\n
          • Computer System Validation\n
              \n
            • Building Automation Systems<\/li>\n
            • Process Automation Systems<\/li>\n
            • Vendor Controls<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>\n\t\t<\/div><\/div>
              \n\n
              \n\t\n<\/div>\n\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"

              Philosophy Represent the best interest of our clients Involve QA Early Work as if we are our client’s employees Approach Establish consensus of requirements early, repeat them Communicate, small issues will grow Define roles and responsibilities early, repeat them Realize<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"http:\/\/csg.tommymccullough.com\/index.php?rest_route=\/wp\/v2\/pages\/62"}],"collection":[{"href":"http:\/\/csg.tommymccullough.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/csg.tommymccullough.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/csg.tommymccullough.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/csg.tommymccullough.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=62"}],"version-history":[{"count":6,"href":"http:\/\/csg.tommymccullough.com\/index.php?rest_route=\/wp\/v2\/pages\/62\/revisions"}],"predecessor-version":[{"id":132,"href":"http:\/\/csg.tommymccullough.com\/index.php?rest_route=\/wp\/v2\/pages\/62\/revisions\/132"}],"wp:attachment":[{"href":"http:\/\/csg.tommymccullough.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=62"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}