1.0 Commercial in Confidence 16-Aug-2006 1 of 6 Document Control SOP Document No: SOP_0103 Prepared by: David Brown Date: 16-Aug-2006 Version: 10
1.0 Commercial in Confidence 16-Aug-2006 2 of 6 Document Approval Name Role Date Signature David Brown Author Document History Version Author Date Description 1.0 David Brown 16-Aug-2006 First draft.
1.0 Commercial in Confidence 16-Aug-2006 3 of 6 Table of Contents 1 INTRODUCTION... 4 1.1 Purpose... 4 1.2 Scope... 4 1.3 Definitions... 4 1.4 References...4 2 Procedure... 5 2.1 Main Document Control Elements... 5 2.2 Changes after Formal Issue... 5 2.3 Validation Documentation Distribution... 6 2.3.1 Document Effectivity... 6 2.3.2 Distribution Lists... 6 2.4 Document Management... 6
1.0 Commercial in Confidence 16-Aug-2006 4 of 6 1 INTRODUCTION 1.1 Purpose 1.2 Scope This document details the procedures for the management of documents related to the validation process. Department/Section: All This standard operating procedure applies to all documents directly related to the validation process. 1.3 Definitions None. 1.4 References None.
1.0 Commercial in Confidence 16-Aug-2006 5 of 6 2 Procedure Document control consists of the following: 1. Main document control features. 2. Changes after first formal issue. 3. Distribution lists and copy numbers. 2.1 Main Document Control Elements The main document control elements are: 1. Document Reference the main reference for the document. Allocated on the first draft being written and never modified. 2. Author the author of the current issue of the document 3. Date of issue the issue date of the document. 4. Issue the issue of the document 5. Document Approval the names of the author, the checker of the document and the approver of the document. The checker of the document is the one who verifies that all review actions have been performed. 6. Document History A list of all issues of the documents, the dates and reasons for the change. 2.2 Changes after Formal Issue After a document has been placed under formal change control (Issue 1.0), any subsequent changes to the documents should be made under the validation control process and any changes to the document tracked. Once the document has passed through a successful review the any tracked changes can be removed prior to the next formal issue. Sometimes, due to the limitations of Microsoft Word and/or complexity of the document this may not be possible.
1.0 Commercial in Confidence 16-Aug-2006 6 of 6 2.3 Validation Documentation Distribution 2.3.1 Document Effectivity When a copy of a document related to the validation process is printed its effectivity must be shown in the footer of the document. The footer of the document must state clearly the following: The date the copy was printed or created in the case of electronic documents. The name of the person issued with the copy of the document. The number of days the document is effective for (usually no longer that 90 days). The statement This is a copy of an original document. 2.3.2 Distribution Lists Occasionally some documents will require distribution lists and associated copy numbers. These will be maintained with the document history and approval sections and should contain the name of the individual, their organisation and an associated copy number. 2.4 Document Management Validation documents must be managed securely to ensure their integrity. Validation documents may be scanned and stored in TIFF image file format or stored on microfilm to provide a backup of the paper originals. If electronic documents are regarded as master documents in the validation process a system and/or processes that comply with FDA 21 CFR Part 11 must be used to ensure their integrity and that appropriate electronic signatures are used.