(The date when the associated CAPA task is due, if applicable, or the date the change MUST be implemented by in order to prevent supply chain disruptions or shortages.)
(If neither “Must Implement Dates” apply, then leave “None” above.)
Change Detail Information
Change Type: (Check all that apply) As per section 2
NOTE: For manufacturing materials and supplier changes refer to MPR-PPC-PP-009057 for additional requirements.
Background/Context: (Provide an expert overview in non-expert format/terms of the situation. Regulating Agencies are not familiar with our processes.) Suggested – Provide any information that could support understanding of the change and its context in non-expert terms
Instructions Note: Throughout this document all blue italics text indicates instruction and example content. It is intended to be deleted and/or replaced with authored content. Information in black text is required and must be included. Examples to include (can be written as paragraph or list):
Site Risk Documentation (ex. FMEA): Supporting Document Number / ID:
Characterization: Supporting Document Number / ID:
Verification: Supporting Document Number / ID:
Validation: Supporting Document Number / ID:
Qualification: Supporting Document Number / ID:
Equipment Installation: Supporting Document Number / ID:
Other Testing or Rationale not listed above:
Supporting Document Number / ID:
Software Change Control Form / ID: ______________
Provide rationale for no testing:
______________
Outline the current template and future state (From/To) by filling out the following template. If needed, include additional detail in attached (NOT embedded) supporting documents/change table (for example, multiple sub-changes needed for one software release update).
From: supplier/BU is using component/spec/item for processto do x.
To: supplier/BU is using test for test to do some stuff Notes:
