Quality Owners can access the Standard Operating Procedures (SOP’s), work instructions, form templates provided by Enzyme. 

These documents can be downloaded from the Document Library in the app and customized to a company’s business processes. 

 Video on accessing the Document Library

Steps on accessing the Document Library 

  1. Under the User Settings menu, scroll down to Document Library. 

2. Once in the library, there are three tabs: 

  • HW/SW/IVD Quality Systems: For products that are Hardware only, Hardware/Software combination  or In-vitro Diagnostic
  • SaMD Quality Systems: SOPs that have been updated specifically for SaMD only companies.
    Note: balance of necessary SOPs must be downloaded from HW/SW/IVD Quality Systems tab
  • Other: Access Enzyme Validation reports, ISO 9001-2015 Certificate and Supplier Self Assessment

3. Select the tab that applies to your need.  The main download button allows you to download ALL the documents in that tab. 

4. Selecting the three dots and then download button allows you to download an individual document.

5. Once the document (s) have been downloaded, they can be customized as needed. 

If you have any questions, you can reach us through the chat or email us at support@enzyme.com. 

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