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,

Product Complaint

Product complaint includes issues reported by customers, healthcare providers, distributors, or internal stakeholders about a pharmaceutical product.

What is product complaint handling

Product Complaint Handling is a regulated quality and pharmacovigilance process where issues reported by customers, healthcare providers, distributors, or internal stakeholders about a pharmaceutical product are logged, investigated, and resolved. These complaints may involve product quality defects, packaging errors, labeling mistakes, adverse drug reactions (ADRs), or distribution failures.

Types of product complaints

  • Product Quality: Covers defects that affect the physical characteristics of the drug product.

  • Packaging Defect: Encompasses issues with the external or protective packaging.

  • Labeling Error: Applies to inaccuracies or omissions in printed or affixed labels.

  • Adverse Drug Reaction: Refers to unexpected or harmful responses experienced after using the drug as prescribed.

  • Distribution Issues: Concerns linked to the supply chain and product delivery.

  • Counterfeit or Fraud: Suspicion or confirmation of falsified products in the supply chain.

  • Other: Covers all complaints that do not fit into the standard categories. Examples include user or operator error, duplicate complaint submissions, or issues that fall outside the defined scope of product, packaging, labeling, ADR, distribution, or fraud.

How to use the product complaint marketplace solution

Before configuring and using the product complaint 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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