Most quality teams control documents in one of three ways: a spreadsheet, a SharePoint site or a dedicated QMS. Each works until an audit against ISO 9001 or FDA 21 CFR Part 11 exposes the gaps. This guide is an honest framework for choosing the right tool for where you are today. It walks through what breaks at each stage of growth and why, from version control failing on shared drives to SharePoint’s freely editable live documents, and shows what changes when document control connects to CAPA, training and audit trails. It includes real examples from regulated manufacturers who made the move.







