Compliance Checklist CFR 820

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Medical Device CFR 820 Checklist - Gap Analysis
$190.00
$190.00

Quick Overview

Are you in compliance with the 21 CFR 820 requirements? This check list can be used to identify gaps in your Quality Systems. The checklist is guiding you with relevant questions through all sections and requirements of the 820. It can be used as internal audit aid or as a questionnaire for external suppliers and contractors.

CFR 820 compliance check - gap analysis

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  • CFR 820 compliance check - gap analysis

Details

General

The purpose of this checklist is to verify that a organisation is complainant to 21 CFR 820 Quality System Regulations. This evaluation checklist can be used as part of a supplier evaluation or audit process or as an checklist for internal auditing or to perform a gap analysis as part of any compliance program or inspection readiness initiative.

 

Regulatory basis, reference documents

US Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) part 820

 

Table of Content:

1          Purpose & Objective

2          Regulatory basis, reference documents

3          Responsibility and accountability

4          Definitions

5          Procedure

5.1       820.20 – Management Responsibility

5.2       820.22 – Quality Audits

5.3       820.25 – Personnel

5.4       820.30 – Design Controls

5.5       Design and Development planning

5.6       Design Input

5.7       Design Output

5.8       Design Reviews           

5.9       Design Verification

5.10      Design Validation

5.11      Design Transfer           

5.12      Design History File

5.13      820.40 – Document Controls

5.14      820.50 – Purchasing Controls

5.15      820.60 – Identification

5.16      820.65 – Traceability

5.17      820.70 – Production and Process Controls

5.18      820.72 – Inspection, Measuring, and Test Equipment

5.19      820.75 – Process Validation

5.20      820.80 – Receiving, in-process, and finished device acceptance

5.21      Receiving acceptance activities

5.22      In-Process acceptance activities

5.23      Final Acceptance Activities

5.24      820.86 – Acceptance Status

5.25      820.90 – Non-Conforming Product

5.26      820.100 – Corrective and Preventive Action

5.27      820.120 – Device Labeling

5.28      820.130 – Device Packaging

5.29      820.140 – Handling

5.30      820.150 - Storage

5.31      820.160 - Distribution

5.32      820.170 - Installation

5.33      820.180 – General Requirements

5.34      820.181 – Device Master Record

5.35      820.184 – Device History Record

5.36      820.186 – Quality System Record

5.37      820.198 – Complaint Files

5.38      820.200 – Servicing

5.39      820.250– Statistical Techniques

6          Attachments


Size and Format:

  • Microsoft Office 2003
  • Word File
  • 24 pages checklist - gap analysis

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