Document and Record Control — Process Package (ISO 13485)
€69.00Audit-ready Document Control SOP plus 3 templates: Master List, Change Request Form, and Record Destruction Authorization. Aligned with ISO 13485:2016 §4.2 and 21 CFR Part 11.
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Document Control SOP + Templates — ISO 13485 & MDSAP Compliant
€69.00Process Package — Document and Record Control A complete, audit-ready document control system covering all requirements of ISO 13485:2016 §4.2.4–4.2.5, MDSAP Chapter 1, and 21 CFR Part 11 for electronic records. What’s included: SOP-CORE-01 Document and Record Control — full standard operating procedure with cover page, control page, responsibilities matrix, document hierarchy, lifecycle workflow, periodic…
