This Help Center is a preview of a future release. The final Help Center will be available on the Validation date.

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 = Troubleshooting,; Topic = Multienterprise Information Network Tower (MINT),;Persona = TraceLink Administrator, User,; Orchestration = Manufacturing, Logistics, Commerce, Transportation, Clinical Supply,; Function = Supply Chain, IT, Procurement,

Change Request

In the pharmaceutical supply chain, a change request is a formal proposal to modify an existing process, system, material, document, or equipment.

What is a change request

A change request ensures that any alterations to an existing process, system, material, document, or equipment are systematically evaluated, approved, and implemented without compromising product quality, safety, or regulatory compliance. The change control process in the pharmaceutical industry typically involves the following steps:

  1. Initiation: A change request is formally documented, detailing the proposed change and its rationale.
  2. Impact Assessment: An evaluation is conducted to assess the potential effects of the change on product quality, safety, and compliance.
  3. Approval: The change request is reviewed and approved by a cross-functional team, often including quality assurance, regulatory affairs, and operations.
  4. Implementation: Once approved, the change is implemented according to a predefined plan, ensuring minimal disruption to ongoing operations.
  5. Verification: Post-implementation reviews are conducted to confirm that the change has achieved its intended outcomes without unintended consequences.
  6. Documentation: All steps of the change control process are thoroughly documented for traceability and regulatory compliance.

Types of change requests

  • Process Changes: Modifications in manufacturing procedures, such as altering mixing times or temperatures.

  • Material Changes: Switching suppliers for active pharmaceutical ingredients (APIs) or excipients.

  • Equipment Changes: Upgrading or replacing machinery used in production or packaging.

  • Documentation Changes: Revising standard operating procedures (SOPs), batch records, or quality manuals.

  • Facility Changes: Renovations or expansions that might affect production environments.

  • Regulatory Changes: Implementing new guidelines issued by regulatory bodies like the FDA or EMA.

How to use the change request marketplace solution

Before configuring and using the change request marketplace solution, Solution Designers must first save the latest version of the marketplace solution from the marketplace catalog as a company solution. Once saved, Solution Designers can modify and release them into their Company Catalog. For more information about using marketplace solutions, see OPUS Solution Environment Help Center.

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