Quality and Technical Agreement

In the General section fill in the following fields:

1. Title field – Enter Provide the title for the Quality and Technical Agreement. This field is required.
2. Description field – Enter Provide a description of the Quality and Technical Agreement.

In the General section update the following fields:

1. Update the Display Identifier field – System-generated unique identifier for the Quality and Technical Agreement; format QTA-000001 with a configurable prefix.
2. Title field – Descriptive title of the Quality and Technical Agreement.
3. Description field – Background for the collaboration request.
4. Agreement Initiation Reason field – 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 – Role of the external partner.
6. Business Priority field – Business priority: Critical, High, Medium, or Low.
7. Due Date field – Target completion date by which the process should be completed.

In the Participants section update the following fields:

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

In the Agreement Overview section update the following fields:

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

In the Operational Scope section update the following fields:

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

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

1. Applicable Markets field – Markets where the covered product, service, or activity applies.
2. Applicable Regulations field – Regulatory or quality frameworks applicable to the agreement.
3. Confidentiality Level field – Confidentiality classification: Public, Internal, or Confidential.
4. Legal Review Required field – Indicate whether legal review is Required, Not Required, or To Be Determined.
5. Notes field – Scope summary notes.

In the Agreement Reference Documents section update the following fields:

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

In the Quality Agreement Drafting section update the following fields:

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

In the Technical Agreement Drafting section update the following fields:

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

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

1. Review Summary field – Summary of major review outcomes, unresolved issues, or negotiation points.
2. Reviewer field – Assigned Owner reviewer.
3. Review Outcome field – Owner reviewer outcome: Review Accepted, Review Accepted with Comments, or Review Findings - Negotiation Required.

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

1. Review Summary field – Summary of major review outcomes, unresolved issues, or negotiation points.
2. Reviewer field – Assigned Partner reviewer.
3. Review Outcome field – Partner reviewer outcome: Review Accepted, Review Accepted with Comments, or Review Findings - Negotiation Required.

In the Negotiation Log section update the following fields:

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

In the Closure Summary section update the following fields:

1. Legal Review Completed field – Whether legal review is completed.
2. Owner Agreement Status field – Owner agreement status: Accepted or Not Accepted.
3. Partner Agreement Status field – Partner agreement status: Accepted or Not Accepted.
4. Final Quality Agreement Document field – Final clean Quality Agreement document when applicable.
5. Final Technical Agreement Document field – Final clean Technical Agreement document when applicable.
6. Next Review Date field – Date by which the next periodic review should be completed.
7. Agreement Effective Date field – Date the executed agreement becomes active.
8. Agreement Expiry Date field – Optional expiry date of the agreement.
9. Final Outcome field – Final business outcome: Effective, Withdrawn, Canceled, or Replaced by New Agreement.
10. Closure Summary field – Overall summary of the completed agreement lifecycle and final outcome.
11. Closed By field – User closing the agreement lifecycle; auto-populated.
12. Date Closed field – Date and time the agreement lifecycle was closed; auto-populated.

In the Comments and Attachments section update the following fields:

1. Comment Author field – User who entered the comment; system generated.
2. Last Modified field – Date and time when the comment was last modified.
3. Comment field – Text of the comment.
4. Visibility field – Visibility setting for the comment or attachment.
5. Attachments field – Files attached to the Quality and Technical Agreement.

In the Followers section update the following fields:

1. Followers field – Users who follow the Quality and Technical Agreement.

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.

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