Quality Management

Document Management and good documentation practise for validation documents

  • Check if SOP for "Documentation" within QMS is existing (supplier and client)
  • Generate Validation Templates (version controlled, centralized, easy-to-use)
  • Don't make yourself looking stupid and stop thinking Document Management (DM) is only personnal assistants' stuff...

Make the effort of defining some DM rules at the beginning of your validation effort and you will save a lot of time when your project will be "running for good"...

A good DM SOP should include provisions for the following:

  • Management of Templates (including authority for reviewing and approving; storage; identification; "template for templates" for consistent signature logs, history logs, header, footer, general layout...)
  • Document types
  • Document numbering
  • Document versioning
  • Document lifecycle and general definition of roles (authors, reviewers, approvers)
  • Definition of transversal roles: Document Manager, Document Coordinator...
  • Cross referencing (may provide the maintenance of a central repository of cross-references... A very basic 2 columns Excel file that will make your "impact assessment" so much easier when you will be coming up with the new version of an existing document...)
  • Authorized and respective roles of formats: "native" electronic, electronic / PDF, paper format...
  • Meaning of signatures according to different roles; possible use of electronic signatures and technical requirements for that latter
  • Storage (with respect of formats and "master" Vs. "working" copies)
  • Delegation of authority: temporary and/or permanent
  • Provisions for document updates, relationship with change control SOP (when / under which circumstances can we get rid of a full CC process for updating a document??)

If no "general" DM SOP is available, one can be created for the sake of a specific project. When there is one available, it should be referred into your Validation Plan. Project-specific provisions should be detailed in the VP, especially by further defining the "roles for Doc Management" with respect to the project team / project responsibility matrix.

No comments: