POET is not designed to serve as the system of record for regulated processes, therefore not subject to GxP requirements. It is designed to enable cross-organizational collaboration and process orchestration, while the system of record for each process remains within the respective enterprise systems.

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Operator Certification Tracking

Operator Certification Tracking helps organizations monitor, manage, and document operator certifications, qualifications, and training evidence so operators are authorized to perform specific tasks or use specific equipment.

What is operator certification tracking

Operator certification tracking is a structured process used to document operator competency, certification scope, supporting evidence, review status, and closure outcomes.

  1. Initiation - A certification tracking record is created for an operator.
  2. Scope Definition - The certification nature, functional area, operator role, and applicable regulatory frameworks are defined.
  3. Evidence Collection - Certification details, supporting documents, equipment, procedure, role, process, or safety information are collected.
  4. Review - The submitted certification evidence is reviewed against required certification criteria.
  5. Closure - The final certification outcome is captured and the record is closed.

Types of operator certification tracking

  • Equipment Certification Tracking - Tracks operator certification related to equipment use or operation.

  • Procedure Certification Tracking - Tracks certification against procedures or SOPs.

  • Equipment and Task Certification Tracking - Tracks certification that combines equipment and task requirements.

  • Role-Based Certification Tracking - Tracks certification based on operator role or competency requirements.

  • Process and Product Certification Tracking - Tracks certification for specific process or product requirements.

  • Safety and Compliance Certification Tracking - Tracks certification related to safety and compliance standards.

How to configure the operator certification tracking marketplace solution

Before using the operator certification tracking marketplace solution, Solution Designers must first configure the solution in OPUS Solution Environment (OSE) by completing the following steps:

Solution Designers must first save the latest version of the marketplace solution from the marketplace catalog as a company solution.

  1. Select the Main Menu icon.
  2. Select OPUS Solution Environment.
  3. Select Catalog from the left menu.
  4. Select Marketplace Solutions.
  5. On the Search Solutions page, filter the list of solutions to find the required solution.
  6. Find the latest version of the solution and select the Solution Name to open the solution.
  7. On the Solution Details page, select Save As.
  8. On the Save As panel, fill in the following fields:
    1. Solution Name field – The name of the solution that will be saved as a company solution.
    2. Description field – (Optional) The description of the solution.
  9. Select Apply.
    The marketplace will be saved as a company solution in the Available tab on the left menu.

After saving the solution as a Company Solution, Solution designers must create a network for the solution from OPUS Administration.

  1. Select the Main Menu icon.
  2. Select Administration.
  3. Select Network and Apps from the left menu.
  4. Select New.
  5. In the Network Information section, fill in the following fields:
    1. Application drop-down – Select the application for which you want to configure the marketplace solution. For e.g. Process Orchestration for Empowered Teams.
    2. Network Name field – The name of the network being created.
    3. Network Description field – (Optional) The description of the network being created.
  6. In the Solution section, fill in the following fields:
    1. Standard Solution toggle – This value must be no as the solution for which the network is being created is a marketplace solution.
    2. Company Solution field – Select the solution that you saved as a company solution in the previous procedure.
  7. Select Save.
    The new network is created and the solution is ready for use.

After creating a network for the solution, Solution Designers must define roles for accessing the network.

  1. Select the Main Menu icon.
  2. Select Administration.
  3. Select Users from the left menu.
  4. Select Network Members from the left menu.
  5. On the Search Network Members page, filter the list of network members by the network created in the previous procedure.
  6. Select the user email of the user who created the network.
  7. Select Edit.
  8. In the Roles section, select the role required to access the network.
  9. Select Save.
    The role to access the new network is configured.

Add an operator certification tracking

Add an operator certification tracking by entering the required details.

  1. Select the Main Menu icon.
  2. Select My Networks.
  3. Select a [POET Network] from the Select your Network drop-down in the header.
  4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
  5. Select Go.
  6. Select Operator Certification Tracking from the left menu.
  7. Select New.
  8. In the General section fill in the following fields:
    1. Title field - The title of the operator certification tracking.
    2. Description field - The description of the operator certification tracking.
  9. Select Save.
    The operator certification tracking is created in the Draft state.
  10. To move the operator certification tracking to To Do state, select Move to.

Modify an operator certification tracking

Modify an existing operator certification tracking by updating the required details.

  1. Select the Main Menu icon.
  2. Select My Networks.
  3. Select a [POET Network] from the Select your Network drop-down in the header.
  4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
  5. Select Go.
  6. Select Operator Certification Tracking from the left menu.
  7. Select the Display Identifier of the record to edit.
  8. Select Edit.

  9. In the General section update the following fields:

    1. Display Identifier field - System-generated identifier for the operator certification tracking.
    2. Title field - The title of the operator certification tracking.
    3. Business Priority field - The urgency level for the operator certification tracking.
    4. Functional Area field - The department or business function associated with the certification.
    5. Due Date field - The target completion date for the operator certification tracking.
    6. Description field - The overview or background information for the operator certification tracking.

  10. In the Operator section update the following fields:

    1. Operator ID field - The unique operator identifier.
    2. Email field - The email address of the operator.
    3. Name field - The name of the operator selected from the platform user directory.

  11. In the Participants section update the following fields:

    1. Initiator Company Business Name field - The business name of the initiator company.
    2. Initiator Company Identifier Type field - The identifier type of the initiator company.
    3. Initiator Company Identifier Value field - The identifier value of the initiator company.
    4. Assignee Company Business Name field - The business name of the assignee company.
    5. Assignee Company Identifier Type field - The identifier type of the assignee company.
    6. Assignee Company Identifier Value field - The identifier value of the assignee company.
    7. Assignee User Email field - The email address of the person assigned to the operator certification tracking review.
    8. Assignee User Name field - The name of the person assigned to the operator certification tracking review.

  12. In the Certification Information Collection section update the following fields:

    1. Operator Role field - The operator role covered by the certification.
    2. Certification Nature field - The type of certification being assessed.
    3. Role Category field - The category of the operator role covered by the certification.
    4. Regulatory Frameworks field - The applicable regulatory standards associated with the certification.

    5. If Equipment is selected in the Certification Nature field, then update the following fields:

      1. Equipment Name field - The name of the equipment associated with the certification.
      2. Equipment ID field - The unique equipment identifier used for traceability.
      3. Equipment Type field - The type or category of equipment associated with the certification.
      4. Other Equipment Type field - The equipment type when the selected equipment type is Other.
      5. Manufacturer field - The manufacturer of the equipment.
      6. Equipment Model Number field - The model number of the equipment.
      7. Equipment Location field - The facility, room, zone, or location where the equipment is used.
      8. Qualification Status field - The current qualification status of the equipment.

    6. If Procedure is selected in the Certification Nature field, then update the following fields:

      1. Procedure Name field - The name of the procedure associated with the certification.
      2. SOP Reference Number field - The reference number for the SOP associated with the certification.
      3. SOP Version field - The SOP version at the time of certification.
      4. SOP Effective Date field - The effective date that confirms the currency of the procedure.
      5. Supporting Document field - The governing procedure document or supporting evidence for the certification.

    7. If Role is selected in the Certification Nature field, then update the following fields:

      1. Competency Framework Reference field - The reference to the competency framework or job role standard being assessed.
      2. Competency Areas Covered field - The competency domains covered by the certification.
      3. Scope of Role field - The operational responsibilities covered by the role-based certification.

    8. If Product and Process is selected in the Certification Nature field, then update the following fields:

      1. Process Name field - The process associated with the certification.
      2. Product Code field - The product code associated with a product-specific certification.
      3. Process Stage field - The process stage associated with the certification.
      4. Other Process Stage field - The process stage when the selected process stage is Other.
      5. Batch Record Reference field - The reference to the master batch record or process document.
      6. Supporting Document field - The relevant process document or batch record.

    9. If Safety and Compliance is selected in the Certification Nature field, then update the following fields:

      1. Safety Standards field - The safety and compliance standards applicable to the certification.
      2. Other Safety Standard field - The safety standard when the selected safety standard is Other.
      3. Risk Category field - The risks linked to certified activities.
      4. Permitted Activities field - The activities the operator is permitted to perform under the certification.
      5. Restrictions field - The activities excluded from the certification or conditions under which the certification does not apply.

  13. In the Certification Details section update the following fields:

    1. Credential field - The credential associated with the certification.
    2. Issuing Authority field - The organization or body that issued the certification.
    3. Issued Date field - The date the certification was originally issued.
    4. Expiration Date field - The date the certification expires.
    5. Certification Validity Period field - The length of time for which the certification remains valid.
    6. Certificate Document field - The certificate document associated with the certification.
    7. Certification Notes field - The assignee summary or annotation of the submitted evidence.
    8. Witness Email field - The email address of the witness present during certification.
    9. Witness Name field - The name of the witness present during certification.

  14. In the Certification Review Checklist section update the following fields:

    1. Issuing authority is accredited field - Confirmation that the issuing body is acceptable per site SOPs or regulatory expectations.
    2. Credential verified against issuing authority field - Confirmation that the credential has been verified against the issuing authority.
    3. Operator identity verified field - Confirmation that the certificate on file belongs to the operator on the record.
    4. Expiration date within acceptable range field - Confirmation that the certification is not expired or imminently lapsing.
    5. Certificate document legible and complete field - Confirmation that the uploaded certificate is readable and complete.
    6. Regulatory standard / framework alignment confirmed field - Confirmation that the certification aligns with the specified regulatory framework.
    7. Certification scope matches operational role field - Confirmation that the certification scope matches the operator's operational responsibilities.
    8. Qualification Status of equipment confirmed field - Confirmation of equipment qualification status when equipment certification applies.
    9. SOP version is current at time of certification field - Confirmation that the SOP version is current when procedure certification applies.
    10. Process document is current approved version field - Confirmation that the process document is current when process or product certification applies.
    11. Safety standard is site-approved field - Confirmation that the safety standard is site-approved when safety or compliance certification applies.
    12. Witness signature present field - Confirmation that the witness record is present.
    13. Review Notes field - The initiator's observations and findings from reviewing the evidence package.

  15. In the Closure Summary section update the following fields:

    1. Closure status field - The final outcome of the operator certification tracking.
    2. Next Review Date field - The date on which the certification should be reviewed again.
    3. Closure notes field - The final remarks and sign-off summary.
    4. Date closed field - The date and time the operator certification tracking was closed.
    5. Closed By field - The user who transitioned the operator certification tracking to Closed.
  16. Select Save.

Workflow

The workflow defines the lifecycle of an operator certification tracking record from creation to closure. Each state represents a stage in the collaboration process between the Owner and Partner organizations.

Base State Workflow State Description
Draft Draft The initiator creates the certification record.
To Do To Do The initiator defines the certification type and functional area and sends the record to the assignee.
Submitted Submitted The assignee submits key certification details and supporting evidence documents.
Certification Under Review Certification Under Review The initiator validates the certification against the evidence package provided by the assignee.
Closed Closed The final review outcome is captured and the record is closed.

Monitor operator certification tracking

Monitor operator certification tracking records using dashboards and search to track progress, monitor key activities, and analyze performance.

  1. Select the Main Menu icon.
  2. Select My Networks.
  3. Select a [POET Network] from the Select your Network drop-down in the header.
  4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
  5. Select Go.
  6. Select Operator Certification Tracking.
  7. Select Dashboards.
Metric Description
Current Trends
Operator Certification Tracking by Status – Open Total number of Operator Certification Tracking records categorized by Status (Draft, To Do, In Progress).
Operator Certification Tracking by Business Priority Number of Operator Certification Tracking records of Status (Draft, To Do, In Progress) categorized by Business Priority (Critical, High, Medium, Low).
Operator Certification Tracking by Functional Area Total number of Operator Certification Tracking records of Status (Draft, To Do, In Progress) categorized by Functional Area such as Manufacturing, Quality Assurance, Quality Control, Laboratory Operations, Engineering, Warehouse Operations, etc.
Operator Certification Tracking by Certification Nature Total number of Operator Certification Tracking records of Status (Draft, To Do, In Progress) categorized by Certification Nature (Equipment Operation, Procedure, Equipment and Procedure, Role, Process and Product Specific, Safety and Compliance).
Operator Certification Tracking by Role Category Total number of Operator Certification Tracking records of Status (Draft, To Do, In Progress) categorized by Role Category.
Due Date Monitoring
Operator Certification Tracking Overdue Total Number of Operator Certification Tracking with Due Date less than the current date/time categorized by Status (Draft, To Do, In Progress).
Operator Certification Tracking Due in Next 24 Hours Total Number of Operator Certification Tracking with Due Date within the next 24 hours categorized by Status (Draft, To Do, In Progress).
Operator Certification Tracking Due in Next 7 Days Total Number of Operator Certification Tracking with Due Date within the next 7 days from the current date categorized by Status (Draft, To Do, In Progress).
Operator Certification Tracking Due in Future Total Number of Operator Certification Tracking with Due Date greater than or equal to the current date/time categorized by Status (Draft, To Do, In Progress).
Network Performance
Operator Certification Tracking by Assignee Company Total number of Operator Certification Tracking records of Status (Draft, To Do, In Progress) categorized by Assignee Company.
Operator Certification Tracking by Assignee User Total number of Operator Certification Tracking records of Status (Draft, To Do, In Progress) categorized by Assignee User.
Operator Certification Tracking by Operator Total number of Operator Certification Tracking records of Operators categorized by Status (Draft, To Do, In Progress).
Operator Certification Tracking – Next Review Date due in 7 Days Total Number of Operator Certification Tracking with Next Review Date Due within the 7 days from the current date categorized by Done Status.
Operator Certification Tracking – Next Review Date Due in 30 Days Total Number of Operator Certification Tracking with Next Review Date Due within 30 days from the current date categorized by Done Status.
Operator Certification Tracking by Certification Nature and Role Category Total number of Operator Certification Tracking records of Certification Nature (Equipment Operation, Procedure, Equipment and Procedure, Role, Process and Product Specific, Safety and Compliance) categorized by Role Category.
Organizational Performance
Operator Certification Tracking by Closure Status Total number of Operator Certification Tracking records in Closed state categorized by Closure Status (Valid, Invalid, Withdrawn).
Average Time to Close Operator Certification Tracking by Closure Status Average time taken to close Operator Certification Tracking records, categorized by Closure Status (Valid, Invalid, Withdrawn).
  1. Select the Main Menu icon.
  2. Select My Networks.
  3. Select a [POET Network] from the Select your Network drop-down in the header.
  4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
  5. Select Go.
  6. Select Operator Certification Tracking.
  7. Select Dashboards.
Metric Description
Current Trends
Operator Certification Tracking by Status – Open Total number of Operator Certification Tracking records categorized by Status (Draft, To Do, In Progress).
Operator Certification Tracking by Business Priority Number of Operator Certification Tracking records of Status (Draft, To Do, In Progress) categorized by Business Priority (Critical, High, Medium, Low).
Operator Certification Tracking by Functional Area Number of Operator Certification Tracking records of Status (Draft, To Do, In Progress) categorized by Functional Area.
Operator Certification Tracking by Certification Nature Number of Operator Certification Tracking records of Status (Draft, To Do, In Progress) categorized by Certification Nature (Equipment, Procedure, Equipment and Procedure Combined, Role, Process and Product Specific, Safety and Compliance).
Operator Certification Tracking by Role Category Total number of Operator Certification Tracking records of Status (Draft, To Do, In Progress) categorized by Role Category.
Due Date Monitoring
Operator Certification Tracking Overdue Total Number of Operator Certification Tracking with Due Date less than the current date/time categorized by Status (Draft, To Do, In Progress).
Operator Certification Tracking Due in Next 24 Hours Total Number of Operator Certification Tracking with Due Date within the next 24 hours categorized by Status (Draft, To Do, In Progress).
Operator Certification Tracking Due in Next 7 Days Total Number of Operator Certification Tracking with Due Date within the next 7 days from the current date categorized by Status(Draft, To Do , In Progress).
Operator Certification Tracking Due in Future Total Number of Operator Certification Tracking with Due Date greater than or equal to the current date/time categorized by Status (Draft, To Do, In Progress).
Network Performance
Operator Certification Tracking by Certification Nature and Role Category Total number of Operator Certification Tracking records of Certification Nature (Equipment Operation, Procedure, Equipment and Procedure, Role, Process and Product Specific, Safety and Compliance) categorized by Role Category.
Organizational Performance Metric
Operator Certification Tracking by Closure Status Total number of Operator Certification Tracking records in Closed state categorized by Closure Status: Valid, Invalid, Withdrawn.
Average Time to Close Operator Certification Tracking by Closure Status Average time taken to close Operator Certification Tracking records, categorized by Closure Status: Valid, Invalid, Withdrawn.
  1. Select the Main Menu icon.
  2. Select My Networks.
  3. Select a [POET Network] from the Select your Network drop-down in the header.
  4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
  5. Select Go.
  6. Select Operator Certification Tracking from the left menu.
  7. Select Filter.

  8. In the Filters panel, fill in one or more of the following fields to filter the results:

    1. Display Identifier field - Search by the display identifier of the operator certification tracking.
    2. Title field - Search by the complete or partial title of the operator certification tracking.
    3. State field - Filter by workflow state such as Draft, To Do, In Progress, or Done.
    4. Creation Time field - Search by the timestamp when the operator certification tracking was created.
    5. Initiator Company field - Search by the business name or identifier of the initiator company.
    6. Assignee Company field - Search by the business name or identifier of the assignee company.
    7. Due Date field - Filter by the due date of the operator certification tracking.
    8. Operator ID field - Search by the operator identifier.
    9. Functional Area field - Filter by the functional area associated with the certification.
    10. Certification Nature field - Filter by the certification nature.
    11. Business Priority field - Filter by the business priority.
    12. Last Modified field - Search by the timestamp when the operator certification tracking was last modified.

  9. Select Apply.
    All operator certification tracking records matching the filter criteria are displayed.

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