Texas: Southwest Chapter

  • 1.  Workflow Options

    Posted 04-24-2021 14:54

    I was given a list of user needs to take under consideration while exploring 3rd party software solutions for electronic record and workflow management. We are currently using Enzyme QMS for all the Quality Records so that we can be in compliance with ISO 13485, CFR Title 21 Part 11, and ISO 9001, however we have some legacy information that is still printed out, passed around for approval, and then scanned in for record. (Please don't judge :-) we are cleaning things up now). Additionally, there are some old spreadsheets we want to migrate into this new workflow. Anyone have a suggestion for a great workflow tool?

    Business Need

    Importance

    Ability to create custom e-form lists that include the following fields types: dropdown, radio, single-line textbox, multi-line textbox, number-entry text box, checkbox, date

    Must have

    Ability to make some fields mandatory and others optional

    Must have

    For each e-form list, ability to assign separate read/write permissions to specific individuals or groups

    Must have

    Ability to restrict access so that only specific individuals or groups may edit e-form configurations

    Must have

    Non-editable audit trail to document fields that are populated or edited including: user, timestamp, original value, new value

    Must have

    Ability for users to apply an electronic signature to an e-form, if required by the configuration

    Must have

    Ability to filter e-forms on specified field values

    Must have

    Ability to export all records for a given e-form list into an Excel spreadsheet

    Must have

    User-friendly and easy to learn/use

    Must have

    Ability to attach files to the e-form

    Must-have

    Ability to create a field type where a user is specified (e.g., "Assigned To")

    Must have

    Integrates with Windows Active Directory for user management

    Nice-to-have

    Ability to set default values for fields

    Nice-to-have

    Ability to search e-forms by typing keywords

    Nice-to-have

    Ability to configure and view fields as columns within the platform. Also ability to sort rows according to desired columns.

    Nice-to-have

    Ability to migrate/populate records by importing from a properly organized spreadsheet

    Nice-to-have

    Ability to specify column validation rules (i.e., allowable values or conditions based on configured logic)

    Nice-to-have

    Ability to configure fields in the e-form that must be conditionally populated depending on other data that was entered (e.g., if Question 1 entered as Yes, fill out Questions 1.a and 1.b).

    Nice-to-have

    Ability to configure workflows with automatic email notifications according to desired field values (e.g., Status field)

    Nice-to-have

    Supports API calls for integration with custom-developed software

    Nice-to-have

    Reasonably Priced (Affordability is relative and TBD)

    Must have

     



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    Georgia H. Hackleman
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