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The procedures and the tools to run them, together. Three tailorable procedures — CAPA, Nonconformance, and Complaint Handling — paired with the QMS Audit & CAPA Toolkit, so you can operate and defend the reactive core of your quality system, not just log it.
Three tailorable procedures (Word): CAPA, Control of Nonconforming Product, and Complaint Handling — each governing its process end to end and linked to the toolkit.
The complete QMS Audit & CAPA Toolkit: gap assessment, CAPA/NC/complaint logs with overdue flags, internal-audit schedule, and a health dashboard, plus CAPA Record and Internal Audit Report templates.
A “How to Tailor These Procedures” guide showing exactly what to edit and how the SOPs link to the logs and templates.
Single-organization license; edit and co-brand for internal use.
Medical device and IVD teams — especially those under a 483/Warning Letter or standing up a quality system — who need the governing procedures and the working trackers for CAPA, nonconformances, and complaints, and to stay inspection-ready.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Standing up a full quality system? QMS-in-a-Box bundles the Quality Manual, twelve SOPs, and every QMS toolkit into one complete, tailorable system.
Because this is an instant digital download, all sales are final and non-refundable. If a file won’t download or appears corrupted, email aaron.vant@medevexconsulting.com and we’ll make it right. Single-organization license; not for resale or redistribution.The procedures and the tools to run them, together. Three tailorable procedures — CAPA, Nonconformance, and Complaint Handling — paired with the QMS Audit & CAPA Toolkit, so you can operate and defend the reactive core of your quality system, not just log it.
Three tailorable procedures (Word): CAPA, Control of Nonconforming Product, and Complaint Handling — each governing its process end to end and linked to the toolkit.
The complete QMS Audit & CAPA Toolkit: gap assessment, CAPA/NC/complaint logs with overdue flags, internal-audit schedule, and a health dashboard, plus CAPA Record and Internal Audit Report templates.
A “How to Tailor These Procedures” guide showing exactly what to edit and how the SOPs link to the logs and templates.
Single-organization license; edit and co-brand for internal use.
Medical device and IVD teams — especially those under a 483/Warning Letter or standing up a quality system — who need the governing procedures and the working trackers for CAPA, nonconformances, and complaints, and to stay inspection-ready.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Standing up a full quality system? QMS-in-a-Box bundles the Quality Manual, twelve SOPs, and every QMS toolkit into one complete, tailorable system.
Because this is an instant digital download, all sales are final and non-refundable. If a file won’t download or appears corrupted, email aaron.vant@medevexconsulting.com and we’ll make it right. Single-organization license; not for resale or redistribution.