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.

Type = Technical Guides,; Topic = OPUS Solution Environment, Process Orchestration for Empowered Teams (POET), OPUS,;Persona = Solution Designer, Solution Partner, Technology Partner,; Orchestration = Logistics,; Function = Regulatory Affairs, Quality,

Quality and Technical Agreement

The Quality and Technical Agreement solution supports collaboration on Quality Agreement, Technical Agreement, or combined Quality and Technical Agreement records. The agreement lifecycle captures the business need, agreement type, partner, initiation reason, scope, ownership, priority, due date, drafting, review, negotiation, and final agreement outcome.

What is Quality and Technical Agreement

A Quality and Technical Agreement is a formal agreement between a pharmaceutical company and a manufacturer, supplier, laboratory, packaging site, or logistics provider. It defines each party’s responsibilities for maintaining product quality, regulatory compliance, and patient safety. The agreement covers activities such as manufacturing, testing, batch release, deviations, change controls, complaints, recalls, audits, and inspections. It also documents technical requirements related to processes, specifications, analytical methods, packaging, and technology transfer. The agreement complements the commercial contract by establishing clear ownership, communication, documentation, and escalation procedures for quality and technical activities.

Types of Quality and Technical Agreement

The Quality and Technical Agreement specification identifies the following agreement types:

  • Quality Agreement

  • Technical Agreement

  • Quality and Technical Agreement

Add a Quality and Technical Agreement

Add a Quality and Technical Agreement 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 Quality and Technical Agreement from the left menu.
  7. Select New.

  8. In the General section fill in the following fields:

    1. Title field – Enter the title for the Quality and Technical Agreement. This field is required.
    2. Description field – Enter a description of the Quality and Technical Agreement.
  9. Select Save.
    The Quality and Technical Agreement is created in the Draft state.

Modify a Quality and Technical Agreement

Modify an existing Quality and Technical Agreement by updating the applicable 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 Quality and Technical Agreement from the left menu.
  7. Select the Display Identifier of the Quality and Technical Agreement to edit.
  8. Select Edit.

  9. In the General section update the following fields:

    1. Display Identifier field – System-generated unique identifier for the Quality and Technical Agreement; format QTA-000001 with a configurable prefix.
    2. Title field – Enter a descriptive title for the Quality and Technical Agreement.
    3. Description field – Enter background information for the collaboration request.
    4. Agreement Initiation Reason field – Select the reason the agreement is initiated, such as Supplier Onboarding, Outsourced GMP Activity, Renewal, Revision, Amendment, Product Scope Expansion, Service Scope Expansion, Facility Scope Expansion, or Regulatory Requirement.
    5. Partner Type field – Select the role of the external partner.
    6. Business Priority field – Select Critical, High, Medium, or Low.
    7. Due Date field – Select the target completion date by which the process should be completed.

  10. In the Participants section update the following fields:

    1. Initiator Company - Business Name field – Select the business name of the Initiator Company.
    2. Initiator Company - Identifier Type field – Select the identifier type of the Initiator Company.
    3. Initiator Company - Identifier Value field – Select the identifier value of the Initiator Company.
    4. Assignee Company - Business Name field – Select the business name of the Assignee Company.
    5. Assignee Company - Identifier Type field – Select the identifier type of the Assignee Company.
    6. Assignee Company - Identifier Value field – Select the identifier value of the Assignee Company.
    7. Assignee User - Email field – Select the Owner or Partner user accountable for agreement coordination.
    8. Assignee User - Name field – Enter the name of the assigned user.
    9. Owner Quality Coordinator - Email field – Select the Owner Quality representative responsible for the agreement.
    10. Owner Quality Coordinator - Name field – Enter the name of the Owner Quality Coordinator.
    11. Partner Quality Coordinator - Email field – Select the Partner Quality representative responsible for the agreement.
    12. Partner Quality Coordinator - Name field – Enter the name of the Partner Quality Coordinator.

  11. In the Agreement Overview section update the following fields:

    1. Agreement Type field – Select Quality Agreement, Technical Agreement, or Quality and Technical Agreement.
    2. Agreement Version field – Enter the current agreement version, such as 1.0, 2.0, or Amendment 1.
    3. Related Agreement Reference field – Select the previous agreement associated with this activity when the reason is Renewal, Revision, Amendment, or Replacement.
    4. Master Services Agreement Availability field – Select whether a Master Services Agreement exists, does not exist, or is not applicable.
    5. Purpose and Scope Summary field – Enter the nature of outsourced services, specific products, facilities, laboratories, sites, or operational activities covered.

  12. In the Operational Scope section update the following fields:

    1. Products Covered field – Enter the products covered by the agreement.
    2. Product Classification field – Select the classification of the product or material covered by the agreement.
    3. Services Covered field – Enter the services covered by the agreement.
    4. Service Classification field – Select the classification of the services covered by the agreement.
    5. Sites Covered field – Enter the facilities or sites governed by the agreement.

  13. In the Market Governance and Regulatory Scope section update the following fields:

    1. Applicable Markets field – Select the markets where the covered product, service, or activity applies.
    2. Applicable Regulations field – Select the regulatory or quality frameworks applicable to the agreement.
    3. Confidentiality Level field – Select Public, Internal, or Confidential.
    4. Legal Review Required field – Select Required, Not Required, or To Be Determined.
    5. Notes field – Enter scope summary notes.

  14. In the Agreement Reference Documents section update the following fields:

    1. Document Title field – Enter the name of the supporting document.
    2. Document Source field – Select whether the document was provided by the Owner or Partner organization.
    3. Description field – Enter additional information about the purpose or relevance of the supporting document.
    4. Reference Document field – Select the supporting document relevant to the agreement, such as procedures, specifications, reports, drawings, or appendices.

  15. In the Quality Agreement Drafting section update the following fields:

    1. Provisions Included field – Select the quality topics addressed by the agreement. This section applies when Agreement Type is Quality Agreement or Quality and Technical Agreement.
    2. Agreement Document field – Select the draft Quality Agreement document.
    3. Notes field – Enter drafting assumptions, open quality-content issues, reviewer instructions, or rationale for omitted expected content.

  16. In the Technical Agreement Drafting section update the following fields:

    1. Provisions Included field – Select the technical topics addressed by the agreement. This section applies when Agreement Type is Technical Agreement or Quality and Technical Agreement.
    2. Agreement Document field – Select the draft Technical Agreement document.
    3. Notes field – Enter technical drafting assumptions, open technical-content issues, reviewer instructions, dependencies, or rationale for omitted expected content.

  17. In the Agreement Review by Owner section update the following fields:

    1. Review Summary field – Enter a summary of major review outcomes, unresolved issues, or negotiation points.
    2. Reviewer field – Select the assigned Owner reviewer.
    3. Review Outcome field – Select Review Accepted, Review Accepted with Comments, or Review Findings - Negotiation Required.

  18. In the Agreement Review by Partner section update the following fields:

    1. Review Summary field – Enter a summary of major review outcomes, unresolved issues, or negotiation points.
    2. Reviewer field – Select the assigned Partner reviewer.
    3. Review Outcome field – Select Review Accepted, Review Accepted with Comments, or Review Findings - Negotiation Required.

  19. In the Negotiation Log section update the following fields:

    1. Agreement Document field – Select the agreement document associated with the negotiation item: Quality Agreement or Technical Agreement.
    2. Agreement Section or Clause field – Enter the section number, clause, appendix, schedule, or responsibility-matrix row being discussed.
    3. Description field – Enter the comment, proposed wording, response, or decision.
    4. Negotiation Lead field – Select the person responsible for coordinating, tracking, and driving closure of the negotiation item.
    5. Supporting Negotiation Document field – Select the redlined or revised draft, responsibility matrix, supporting evidence, or decision record.
    6. Resolution Summary field – Enter the agreed decision or reason the negotiation item was removed.
    7. Updated Agreement Document field – Select the agreement draft agreed by both parties.

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

    1. Legal Review Completed field – Select whether legal review is completed.
    2. Owner Agreement Status field – Select Accepted or Not Accepted.
    3. Partner Agreement Status field – Select Accepted or Not Accepted.
    4. Final Quality Agreement Document field – Select the final clean Quality Agreement document when applicable.
    5. Final Technical Agreement Document field – Select the final clean Technical Agreement document when applicable.
    6. Next Review Date field – Select the date by which the next periodic review should be completed.
    7. Agreement Effective Date field – Select the date the executed agreement becomes active.
    8. Agreement Expiry Date field – Select the optional expiry date of the agreement.
    9. Final Outcome field – Select Effective, Withdrawn, Canceled, or Replaced by New Agreement.
    10. Closure Summary field – Enter an overall summary of the completed agreement lifecycle and final outcome.
    11. Closed By field – System-populated user who closes the agreement lifecycle.
    12. Date Closed field – System-populated date and time when the agreement lifecycle is closed.

  21. In the Comments and Attachments section update the following fields:

    1. Comment Author field – System-generated user who entered the comment.
    2. Last Modified field – System-generated date and time when the comment was last modified.
    3. Comment field – Enter the comment text.
    4. Visibility field – Select the visibility setting for the comment or attachment.
    5. Attachments field – Select the files to attach to the Quality and Technical Agreement.

  22. In the Followers section update the following fields:

    1. Followers field – Select the users who follow the Quality and Technical Agreement.
  23. Select Save.

Monitor Quality and Technical Agreements

Monitor Quality and Technical Agreements using the Owner dashboard, Partner dashboard, and search.

  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 Quality and Technical Agreement from the left menu.
  7. Select Dashboards.
Metric Description
Current Trends
Quality and Technical Agreements by Status – Open Total number of open Quality and Technical Agreement records categorized by Status: Draft, To Do, Under Development, In Review, and In Negotiation.
Quality and Technical Agreements by Business Priority Number of open agreement records categorized by Business Priority: Critical, High, Medium, Low.
Quality and Technical Agreements by Agreement Type Total number of open agreements categorized by Agreement Type: Quality Agreement, Technical Agreement, Quality and Technical Agreement.
Quality and Technical Agreements by Agreement Initiation Reason Number of open agreement records categorized by initiation reason such as Supplier Onboarding, Renewal, Revision, Amendment, Product Scope Expansion, Service Scope Expansion, or Regulatory Requirement.
Due Date Monitoring
Quality and Technical Agreements Due in Next 24 Hours Total Number of Quality and Technical Agreements with Due Date within the next 24 hours categorized by Status (Draft, To Do, In Progress).
Quality and Technical Agreements Due in Next 7 Days Total Number of Quality and Technical Agreements with Due Date within the next 7 days from the current date categorized by Status (Draft, To Do, In Progress).
Quality and Technical Agreements Overdue Total Number of Quality and Technical Agreements with Due Date less than the current date/time categorized by Status (Draft, To Do, In Progress).
Quality and Technical Agreements Due in Future Total Number of Quality and Technical Agreements with Due Date greater than or equal to the current date/time categorized by Status (Draft, To Do, In Progress).
Network Performance
Quality and Technical Agreements by Assignee Company Total number of Quality and Technical Agreements of Status (Draft, To Do, In Progress) categorized by Assignee Company.
Quality and Technical Agreements by Assignee User Total number of Quality and Technical Agreements of Status (Draft, To Do, In Progress) categorized by Assignee User.
Quality and Technical Agreements by Partner Type Number of open agreement records categorized by Partner Type such as Supplier, Manufacturer, CDMO, Laboratory, Logistics Provider, Cloud Service Provider, etc.
Agreements Requiring Negotiation Total number of agreements requiring formal negotiation.
Organizational Performance
Quality and Technical Agreements by Final Outcome Total number of closed agreements categorized by Final Outcome: Effective, Withdrawn, Canceled, Replaced by New Agreement.
Average Time to Close Quality and Technical Agreements by Final Outcome Average closure duration categorized by Final Outcome.
Average Time to Close by Partner Type Average closure duration categorized by Partner Type.
  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 Quality and Technical Agreement from the left menu.
  7. Select Dashboards.
Metric Description
Current Trends
Quality and Technical Agreements by Status – Open Total number of open Quality and Technical Agreement records categorized by Status: Draft, To Do, Under Development, In Review, and In Negotiation.
Quality and Technical Agreements by Business Priority Number of open agreement records categorized by Business Priority: Critical, High, Medium, Low.
Quality and Technical Agreements by Agreement Type Total number of open agreements categorized by Agreement Type: Quality Agreement, Technical Agreement, Quality and Technical Agreement.
Quality and Technical Agreements by Agreement Initiation Reason Number of open agreement records categorized by initiation reason such as Supplier Onboarding, Renewal, Revision, Amendment, Product Scope Expansion, Service Scope Expansion, or Regulatory Requirement.
Due Date Monitoring
Quality and Technical Agreements Due in Next 24 Hours Total Number of Quality and Technical Agreements with Due Date within the next 24 hours categorized by Status (Draft, To Do, In Progress).
Quality and Technical Agreements Due in Next 7 Days Total Number of Quality and Technical Agreements with Due Date within the next 7 days from the current date categorized by Status (Draft, To Do, In Progress).
Quality and Technical Agreements Overdue Total Number of Quality and Technical Agreements with Due Date less than the current date/time categorized by Status (Draft, To Do, In Progress).
Quality and Technical Agreements Due in Future Total Number of Quality and Technical Agreements with Due Date greater than or equal to the current date/time categorized by Status (Draft, To Do, In Progress).
Network Performance
Quality and Technical Agreements by Assignee User Total number of Quality and Technical Agreements of Status (Draft, To Do, In Progress) categorized by Assignee User.
Agreements Requiring Negotiation Total number of agreements requiring formal negotiation.
Organizational Performance
Quality and Technical Agreements by Final Outcome Total number of closed agreements categorized by Final Outcome: Effective, Withdrawn, Canceled, Replaced by New Agreement.
Average Time to Close Quality and Technical Agreements by Final Outcome Average closure duration categorized by Final Outcome.
  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 Quality and Technical Agreement 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 using the complete or partial agreement identifier.
    2. Title field – Search using the complete or partial agreement title.
    3. State field – Displays the current workflow state. Customized substates are included in the derived currentState field where configured.
    4. Creation Time field – Search by the timestamp when the record was created.
    5. Initiator Company field – Search using the initiating company business name or identifier.
    6. Assignee Company field – Search using the partner company business name or identifier.
    7. Due Date field – Filter by the target completion date of the agreement activity.
    8. Agreement Type field – Filter by Quality Agreement, Technical Agreement, or Quality and Technical Agreement.
    9. Agreement Version field – Search by the current agreement version, such as 1.0, 2.0, or Amendment 1.
    10. Partner Type field – Filter by the role of the external partner.
    11. Agreement Effective Date field – Filter by the date the agreement became effective.
    12. Next Review Date field – Locate agreements approaching or past their required review date.
    13. Business Priority field – Filter by Critical, High, Medium, or Low.
    14. Last Modified field – Read-only date and time in the system-configured format.

  9. Select Apply.
    All Quality and Technical Agreements matching the filter criteria are displayed.

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