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 remains within 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,

Material Specification Evaluations

Material Specification Evaluations enables Owner and Supplier organizations to collaboratively evaluate and approve a material-source combination against an approved material specification before the material is authorized for GMP supply.

What is a material specification evaluation

A material specification evaluation is an end-to-end collaborative process for exchanging technical information, validating material capability, reviewing supporting evidence, and recording the final qualification outcome for a specific material-source combination.

Types of material specification evaluations

  • New Material
  • Initial Qualification
  • Material Revision
  • Specification Change
  • New Supplier
  • Alternate Supplier
  • Alternate Source Qualification
  • Supplier Change
  • Supplier Site Change
  • Manufacturing Site Change
  • Material Source Change
  • New Grade Qualification
  • Requalification
  • Periodic Review
  • Regulatory Change
  • Compendial Update
  • Analytical Method Change
  • Quality Event
  • Business Continuity
  • Supply Risk Mitigation
  • Shortage / Supply Constraint
  • Process Improvement
  • Cost Reduction
  • Material Retirement / Discontinuation

Add a material specification evaluation

Add a material specification evaluation by entering the required details.

Modify a material specification evaluation

Modify an existing material specification evaluation by updating the required details.

Monitor material specification evaluations

Monitor material specification evaluations using the Owner dashboard, Partner dashboard, and Search.

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