Managing compliance training between an LMS and an eQMS can be highly manual, tedious, and prone to user error. It can become an administrative nightmare and require valuable resources that life science organizations would prefer to utilize in other continuous improvement pursuits.

However, if your organization uses ComplianceWire to manage its role-based training, qualification, and compliance programs, administrators won’t need to manually log training items for users. The Qualio to ComplianceWire Connector manages Controlled Document Training Items between the systems so that Training Items in ComplianceWire are kept in sync as content is updated in Qualio.

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Integration Workflow

The Qualio to ComplianceWire Connector (Connector) pushes the list of documents which require training in Qualio to ComplianceWire. A ComplianceWire Trainer must then manually assign required training on Qualio documents to a Curriculum to assign to the relevant employees. This means that all required training is managed by your Trainers in ComplianceWire and all training records are centralized in ComplianceWire for reporting as well.

For your learners, when they have training assigned to them in ComplianceWire for a Qualio Document, they will see a link to the Qualio document to review the content and they will sign off on their understanding within ComplianceWire.

Integration Details

The Connector allows data to flow from Qualio to ComplianceWire only. Controlled Documents will only be stored in Qualio, while Training Items will only be stored in ComplianceWire with a URL link to the Qualio Controlled Document. Training Records are stored in Compliance Wire. Data transfer frequency is a default of 1 minute.

The following trigger events occur in Qualio to initiate the data transfer:

  • A new document with Training Available = ‘Y’ is Approved

  • When an existing document with Training Available set to 'Y' becomes Effective

  • When an up-versioned document with Training Available set to 'Y' is Approved

  • When an up-versioned document with Training Available set to 'Y' becomes Effective

  • When an existing document with Training Available set to 'Y' and is Retired.

  • When a retired document with Training Available set to 'Y' is Reinstated (Create New Draft Version) and Approved.

Training Items are created and updated when Controlled Documents with Training Required set to ‘Y’ are Approved or Made Effective in Qualio. When Controlled Documents are Approved the Effective Date is set to 14 days time in ComplianceWire. Once approved, the document is ready for training assignment for the 14 day window, and then is made effective. ComplianceWire will automatically make the document Effective on that date. The same process is manual in Qualio; once a document is made Effective in Qualio, the Effective date will sync across to ComplianceWire if it is different to the 14 days previous set.

Definitions

  • Retire Date - Both Qualio and ComplianceWire use a retire date, but the purpose is different. For clarity, the use in both systems is defined here.

    • Qualio Retire Date - This refers to the retirement date for a complete Document in Approved and Effective statuses and all its versions. At this point the document is no longer considered effective and is no longer part of the effective document library.

    • ComplianceWire Retire Date

      • This refers to the specific Training Item Version, which corresponds to a specific version of the document. When V1.0 of a document is superseded by V2.0, then the retire date for V1.0 is set in ComplianceWire, however the document itself is not retired and is now effective on V2.0.

      • When the latest Training Item Version is retired in ComplianceWire the Training Item is then Retired.

  • API User - Access to the Qualio API is through the generation of an API key at the user level. When working with an automated connector the standard approach is to setup a user specifically for accessing the API called an API User.

Integration Requirements

Configuration Options

The following list are configurable options to be considered when implementing the Connector.

  1. Qualio

    1. The ‘Training Period in days’ setting of the Training Items in ComplianceWire can be configured using the Training Due in (Days) setting in Qualio. This will set the Initial Due In and Effective Date of a new Training Items or new Training Items Versions in approved status. Qualio will use the field Organization Settings > Training > Training Due in (Days) if there is a trainee assigned to the Document in Qualio. If no trainee is assigned this will default to 14 days for both initial due in and effective date.

  2. ComplianceWire

    1. Training Curriculum must be configured to accept the Training Items.

Steps to Configure Integration

Customers should be able to complete the following steps, unless specifically noted that Qualio will complete the step, in order to connect their Qualio and ComplianceWire accounts. It is recommended to first connect sandbox/UAT accounts and test the integration before connecting production accounts.

  1. Create a new API user.

    1. In Qualio, create/invite a new API user. It is recommended to create a generic API user and share credentials (securely) with the Quality team to prevent any integration connection issues if a single user is removed from the organization.

    2. Notify Qualio once the user account is created. Qualio will grant this user permissions to view the API Access setting.

  2. Generate the Qualio API Key.

    1. In Qualio, login to the API user account, browse to the Account Settings. Follow instructions provided here to generate the API key.

  3. Work with ComplianceWire to enable the Training Item and Training Item Version API on your account.

  4. Generate the ComplianceWire API Key.

    1. Enable and configure API on ComplianceWire account to generate an API key.

  5. Securely share the following information with Qualio:

    1. API Key for ComplianceWire account

    2. Username and password for ComplianceWire API

    3. Your organization’s Company Code in ComplianceWire (this is a unique identifier associated with your company)

    4. The “Org Name/Node” in Compliance where your training items will be associated.

    5. IP address for ComplianceWire account (for whitelisting purposes)

    6. Email address that will receive notifications regarding threshold limits.

    7. URL for ComplianceWire account (i.e. https://www.compliancewire.com/partners/client)

    8. URL for API endpoint (i.e. https://www.compliancewire.com/gateway/authenticate)

  6. Request Qualio’s IP address to be whitelisted in ComplianceWire.

Field Mapping

There are two ComplianceWire APIs used. Firstly, to create a new training item the Training Item API is used. Secondly, any update to an existing training item is done using the Training Item Version API. The mappings here only include fields on the API that are used for this connector. To see all available fields please refer to the ComplianceWire Documentation.

Training Item API Documentation: https://developer.compliancewire.com/#20

Training Item Version API Documentation: https://developer.compliancewire.com/#25

ComplianceWire: Training Item API

ComplianceWire Attribute Name

Qualio Field

trainingCode

Qualio Field - Document Code

systemType:typeAbbr

Hardcoded - ‘CD’

type:typeName

Hardcoded - ‘Control Document’

organization:orgName

Hardcoded - ‘Company Name in CW’’

version:versionNumber

Qualio Field - Major Version. Minor Version

version:trainingTitle

Qualio Field - Document Title

version:approvalDate

Qualio Field - Approval Date

- When status changes to Approved

version:effectiveDate

Qualio Field - Organization Setting – Training - Training completion period (days) or defaults to 14 days if no trainee is assigned

Qualio Field - Effective Date

- when status changes to effective

version:retireDate

Qualio Field - Retired Date

- When status changes to retired

version:initialDueIn

Qualio Field - Organization Setting – Training - Training completion period (days) or defaults to 14 days if no trainee is assigned

version:initialDueInDatePart *

Initial Due in date is required for CD

days

version:webAddress

Qualio Field - Qualio Document URL.

The URL will not contain the '/training' postfix normally associated with training in Qualio. When navigated to '/training' in Qualio the user will be presented with the content and the call to action to mark the training as complete. However, as the user will be marking the training as complete in ComplianceWire, having the call to action in Qualio as well will cause confusion. Removing the '/training' from the URL navigates the user to the content without any call to action.

ComplianceWire: Training Item Version API

ComplianceWire Attribute Name

Qualio Field

version:requireRetraining

Qualio Field = Is Retraining Required. If ‘Yes’ in Qualio the Training item Version is set to ‘Retraining’, If ‘No’ in Qualio the Training Item Version is set to ‘Equivalent’

version:versionNumber

Qualio Field = Major Version. Minor Version

version:trainingTitle

Qualio Field - Document Title

version:approvalDate

Qualio Field - Approval Date

- When status changes to Approved

version:effectiveDate

Qualio Field - Organization Setting – Training - Training completion period (days) or defaults to 14 days if no trainee is assigned

Qualio Field - Effective Date

- when status changes to effective

version:retireDate

Qualio Field - Retired Date

- When status changes to retired

version:initialDueIn

Qualio Field - Organization Setting – Training - Training completion period (days) or defaults to 14 days if no trainee is assigned

version:initialDueInDatePart *

Initial Due in date is required for CD

days

version:webAddress

Qualio Field - Qualio Document URL.

The URL will not contain the '/training' postfix normally associated with training in Qualio. When navigated to '/training' in Qualio the user will be presented with the content and the call to action to mark the training as complete. However, as the user will be marking the training as complete in ComplianceWire, having the call to action in Qualio as well will cause confusion. Removing the '/training' from the URL navigates the user to the content without any call to action.

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