Lonza SOP - Document Governance/ Implementation of Governing Documents

Document Governance/ Implementation of Governing Documents

Purpose

  • The purpose of this Standard Operating Procedure (SOP) is to define the process required to ensure that all new or revised global governing documents are accurately assessed, approved, and effectively implemented across all applicable sites in a timely manner.

Scope

  • This SOP applies to all Lonza sites and impacts only Good Practice (GxP)-relevant global governing documents.

Definitions and Abbreviations

  • For the purposes of this document, the definitions and abbreviations provided in the following documents apply:
    • CORP-24
    • CORP-30
    • CORP-28
    • GROUP-103284
Key Term: Document Governance Board (DGB)
  • Definition: A cross-functional board responsible for determining whether to implement new or revised documents.

Responsibilities

  • Responsibilities related to the implementation and governance of documents are outlined in subsequent sections to ensure clarity and accountability.
RACI MATRIX
  • A RACI matrix will be provided to clarify roles and responsibilities associated with document governance and its implementation across various sites.

Procedure

  • Detailed procedures are outlined to ensure the pre-approval phases, implementation guidelines, and effectiveness checks are adhered to.
Pre-Approval Phase
  • A defined process will include the assessment of proposed documents to ensure they meet necessary criteria before being sent for approval.
Document Governance Board (DGB)
  • The Document Governance Board will hold meetings to review proposed new or revised documents, allowing for cross-functional input and decision-making.
Implementation of Global Governing Documents
  • The SOP will describe the structured approach required for the actual implementation of approved global governing documents.
Effectiveness Checks
  • Processes to check the effectiveness of implemented documents will be instituted to ensure ongoing compliance and appropriateness.

Related / Informative References

  • A section will delineate related references that complement the SOP content, ensuring users have access to all necessary documentation for implementation.
Related References
  • Specific documents that relate directly to the governance structure can be found and reviewed for further context.
Informative References
  • Additional resources pertinent to the governing documents and procedures may be cited for educational purposes.

Revision History

  • A comprehensive revision history detailing changes made to this SOP will be documented for future reference and accountability.

Appendices/Attachments

  • Relevant appendices and any additional attachments will provide further detail to support the procedures and protocols outlined in this SOP.