Document Changes. Any requests by LONZA or PROTEON for changes to documents which are part of LONZA’s cGMP documentation system, including but not limited to the Master Production Record and any standard operating procedures or Materials Specifications, will be handled by a Change Request using the procedures in Section 3.4.
Document Changes. Changes to documents shall be reviewed and approved. Approved changes shall be communicated to the appropriate personnel in a timely manner. You shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the identification of the approving individual(s), the approval date, and when the change becomes effective.
Document Changes. Except as provided in Article 2 above, preparing Drawings, Specifications or other Design Documents, along with supporting data in connection with Changes to the Work of an Assigned Project.
Document Changes. Supplying Party shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.
Document Changes. Any requests by Paragon or Client to have cGMP documentation, including the Master Batch Record, Master Manufacturing Records, Materials Specifications, and Client specific standard operating procedures, amended or modified in any way will be handled according to the procedures set forth in the Quality Agreement.
Document Changes. The Association hereby covenants and agrees that it shall not adopt any amendment or modification to the Declaration, the Articles of Association or the Memorandum of Association initially executed and recorded by the Declarant, without the prior written consent of the Manager.
Document Changes. 4.5.3.1 Document changes are reviewed and authorized by the Implementation Readiness Review (IRR) committee and Configuration Control Board (CCB) teams. Revised portions of documents are distributed with a change brief, and obsolete documents are removed. A master list specifying the latest issues and revisions is maintained.
4.5.3.2 A notice of change documents is released to the appropriate personnel.
Document Changes. The Customer agrees not to change the Customer’s name or undertake any changes to any documents that the Company has registered, require to be registered or are capable of being registered without the Company’s prior written consent.
Document Changes. Changes to the lifecycle documents describing Gemini (i.e., project plan, product data sheet, compatibility matrix, HW ERS, SW ERS, hardware quality and regulatory plan, analytical performance quality plan, software quality plan) require the previous approval of the project and product managers of both companies. Such changes are often addressed at lifecycle check points but can also be requested at unspecified times as well. Document revisions will be controlled by labeling each copy and every page with a revision string of the form A.00, A.01, A.02, etc. The revision string will be incremented by one each time the document changes, and a record will be entered into the document's revision log with the revision string, the date, and the reason for the update. Documents will also include the document's file name and "Page 1 of x" (where x is the total number of pages) on every page. At HP-CAD project lifecycle documents will be checked into the electronic project notebook (HMS) document control system. At HP PDM will be used for the storage of engineering documents such as drawings and schematics. Documents will be stored at Bruker-Daltronik as MS Word documents. At Bruker-Daltonik, documents will also be stored in a company secure electronic form. As documents are secure, changes will not inadvertently enter into these lifecycle documents.
Document Changes. Any requests by LONZA or Client for changes to cGMP documentation, including the Master Production Record and any standard operating procedures, will be handled by a Client Change Request.
