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| | | This is an unprecedented service to the Quality community. Please feel free to download any documents. Should you want documents in other formats please let us know. Do not forget to see the 1000's of documents we have available - see our Document Index page. | | Title | Description | | IQ/OQ Checklist | IQ/OQ (IQ / OQ installation / operation qualification) checklist. Used as a great way of collecting information for equipment validations. | | SOP skeleton | Basic structure for Standard Operating Procedures. You fill in the meat. These are used by all in the Pharma, Medical Device, IVD, Biotech, ISO industries. | | Approval Form | Approval form used in conjunction with your documents, validations, etc. This is the required page to get your documents through the approval process. | | Barrier Isolator URS | URS (user requirement specifications) for a Barrier Isolator and HVAC System, a mechanical separation between the controlled room environment, and the interior environment in which the pharmaceutical product is processed. The barrier isolator prevents corrosion of materials, do not allow pooling of the cleaning materials, and allow access to the interior as required by the equipment and products. | | | | | | | | | | | | |
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