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The Log Form: System for Change Control Numbers provides a standardized and traceable method for assigning, recording, and managing Change Control (CC) identifiers within your Quality Management System (QMS).


It ensures consistency and auditability across all change-related documentation in compliance with GxP, ICH Q10, and Annex 15 requirements.

 

This form is professionally written and pre-filled (≈ 99% complete), requiring only company name and QA signature before approval.
It forms a critical component of the Change Control process, linking all approved changes, related CAPAs, and training records under a unified numbering system.

 

Includes:

  • Numbering structure for Change Control (C.C.) records

  • Sections for CC number, owner, and issue date

  • QA approval field with signature and date

  • Reference to related documentation (CAPA, SOP updates, etc.)

  • Ready-to-use format for digital or printed QMS use

 

By implementing a controlled numbering system, biotech and life science organizations can ensure full traceability of all changes — a key requirement during EMA and FDA inspections.

SOP 11.2 CC Numbering System Log form

SKU: SOP-SINGLE-11.2
€189.00Price
Excluding VAT
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