FDA

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For some industries, the U.S. Food and Drug Administration (FDA) may require a company to test and validate the way they use a software package. The FDA requires the end user of the software to plan and perform the validation because each company may use the software in a different way. Although it is the end user's responsibility to test and validate the vital software features that they use, below are several documents and details that may be helpful as a starting point for companies that use Fishbowl.

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Fishbowl is developed and supported by a dedicated team in the United States. Fishbowl was first released in 2001 and has been constantly improved and refined since then. Optional updates are typically released once a month. All past changes and upcoming features are available in the Release Notes.

  • To get started, please download and read the FDA General Principles of Software Validation. There are also many online resources that may help you in determining how to create your installation qualification (IQ) or operation qualification (OQ).
  • For many years, the FDA has used Computer System Validation (CSV). It is expected that in 2021 the FDA will release additional guidance regarding Computer Software Assurance (CSA). More information is available here.
  • A PDF of Fishbowl's system requirements and setup guide is available here.
  • The operating systems supported by Fishbowl are listed here.
  • The versions of Fishbowl that are supported by Fishbowl's Support team, are listed here.
  • Fishbowl can track serial numbers, expiration dates, quantities, lot numbers, batches, etc.
  • There are hundreds of reports available for Fishbowl for things such as orders, manufacturing, part aging, barcodes, bill of materials, tracking, receiving history, and more.
  • Fishbowl has hundreds of Access Rights, allowing the features and data available to each user to be customized.
  • Modules in Fishbowl display the last user and the last modified date. In addition, approved users can view a read-only version of the entire Fishbowl database.
  • Fishbowl also offers a free Audit Trail plugin that displays a detailed log of changes that Fishbowl users have made.
    Audit Trail.png
  • To validate that Fishbowl is installed correctly, please follow the installation instructions and verify that each user can login using their personal username and password.
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  • To assist with implementation, Fishbowl provides a 3-page Implementation Flow Chart & Road Map document with checklists for each phase of implementation.
    • Phase 1: Install Fishbowl and prepare for the accounting integration
    • Phase 2: Build the initial Fishbowl database
    • Phase 3: Train on processes
    • Phase 4: Install plugins or integrate with 3rd party apps
    • Phase 5: Finalize data and processes
    • Phase 6: Add inventory and go live with Fishbowl