![]() When you have a document change control management software in place, you can initiate and document the change requests systematically. Investing in a specialized document change control management software can help you align the controlled document changes and upgrades with the quality objectives through: How a Document Change Control Software can help? Most of the document change control management solutions are designed to comply with FDA 21 CFR Part 11 quality standards for documentation including Electronic Signatures and comprehensive Audit Trails. The best way to manage the new-age trend of digitized documents is an electronic document and change control management system. The conventional change control processes may not be effective since the organizations are shifting to digital documentation. How to establish a compliant document change control process? However, you can also prepare a document control checklist to ensure a compliant process. This further ensures that the quality quotient of the end-product doesn’t get affected even if the person at duty changes.ĭocument change control also improves the reliability of a document, ensuring that it has already undergone a regulated process of review and approval. A well-established control process helps to reduce the errors in the critical documents and avoid the inconsistent flow of information. What Document Change Control Process is Intended for?ĭocument change control helps organizations to keep consistency, quality, and compliance of the documents in check. ![]() Their key role is managing the controlled documents using a set of industry best practices and processes. ![]() Some organizations even have the document controllers to classify the specific documents that must be controlled. Well, documents include Quality manual, Quality procedures, Technical designs and drawings, Presentation, Recipe while records include Training certificates, Audit findings, Feedback questionnaire/survey, Meeting minutes, order receipt, etc. You must be wondering What’s the difference. However, the control procedures are applicable to documents as well as records.
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