Your Account |

Show all documents

Standard Operating Procedure

Checklists Master Plans

Pre-Approval-Inspection

GMP Guide

Standard Operation Procedure

FDA

Process Validation

Bookmark this site:

21-CFR 820 Quality systems checklist
Checklist

Description:
This ready-to-use 21 CFR 820 quality audit questionnaire (audit by mail) has been created for the assessment of potential device suppliers that need to comply with the US FDA regulatory requirements set out in 21 CFR 820. The checklist will help you evaluate potential suppliers and cut costs and outlay. This 26-page checklist covers all sections of 21 CFR 820. It can also be used as an inspection checklist for internal or external audits.

Download sample page



	Price:	210.– EUR * (appr. 271.- USD)

* additional 19% tax for customers from germany / no shipping costs will be charged



	Delivery item:
		Editable Word Document You will be able to enter your personal data into the Word Document. Please notice: We do not deliver hard copies.



	Further details: Table of Contents Subpart B - Quality Systems Requirements Section 820.20 – Management Responsibility Section 820.22 – Quality Audits Section 820.25 – Personnel SUBPART C – DESIGN CONTROLS 820.30 – Design Controls Subpart D – Document Controls 820.40 – Document Controls Subpart E – Purchasing Controls 820.50 – Purchasing Controls Subpart F – Identification and Traceability 820.60 – Identification 820.65 – Traceability Subpart G – Production and Process Controls 820.70 – Production and Process Controls Subpart H – Acceptance Activities 820.80 – Receiving, in-process, and finished device acceptance 820.86 – Acceptance Status Subpart I – Non-Conforming Product 820.90 – Non-Conforming Product Subpart J – Corrective and Preventive Action 820.100 – Corrective and Preventive Action Subpart K – Labeling and Packaging Control 820.100 – Device Labeling 820.130 – Device Packaging Subpart L – Handling, Storage, Distribution, and Installation 820.140 – Handling 820.150 - Storage 820.160 - Distribution 820.170 - Installation Subpart M – Records 820.180 – General Requirements 820.181 – Device Master Record 820.184 – Device History Record 820.186 – Quality System Record 820.198 – Complaint Files Subpart N – Records 820.200 – Servicing Subpart O – Statistical Techniques

Customers who bought this item also bought:

Change control system

Annual product review

Supplier certification program

Deviations (failure investigations, non-conformance)

Product Recall


	© GMP ONLINE CONSULTANCY - Impressum - Imprint

21-CFR 820 Quality systems checklist Checklist

21-CFR 820 Quality systems checklist
Checklist