MEDICAL DEVICE

21 CFR PART 820 (The Regulations) [Replace this first paragraph with a short description of your new category. This guidance will appear in the category selection area, so try to keep it below 200 characters. Until you edit this text or create topics, this category won’t appear on the categories page.] ISO 13485

Topic	Replies	Views	Activity
About the MEDICAL DEVICE category MEDICAL DEVICE	0	779	May 22, 2018
Software validation - network and computer system validation 21 CFR PART 820 (The Regulations)	3	2200	August 1, 2018
Medical Device Production and the Importance of the Quality Plan [VIDEO] ISO 13485	0	1022	May 28, 2018
All You Need to Know About Quality Policies – ISO 13485 : 2016 [Video] ISO 13485	0	926	May 23, 2018
Validation of an ERP System 21 CFR PART 820 (The Regulations)	7	2912	April 25, 2016
New product qualification with ETO sterilisation (Validated Process) 21 CFR PART 820 (The Regulations)	0	1154	May 21, 2014
Training records - signatures 21 CFR PART 820 (The Regulations)	2	1705	September 29, 2013
Vendor qualified software on a database version that isn't qualified by the vendor 21 CFR PART 820 (The Regulations)	1	1234	June 14, 2013
Requirements for QA to sign at the end? 21 CFR PART 820 (The Regulations)	6	1715	May 16, 2013
Automatic validation of data by the system 21 CFR PART 820 (The Regulations)	2	1235	January 11, 2013
PRODUCT REGISTRATION DOSSIER in C.T.D format 21 CFR PART 820 (The Regulations)	3	1555	December 6, 2012
ERP system on a multi-tenant host 21 CFR PART 820 (The Regulations)	2	1474	June 11, 2012
EO and Gamma Product Adoption 21 CFR PART 820 (The Regulations)	0	1554	March 22, 2012
Revalidation for Materials Change 21 CFR PART 820 (The Regulations)	4	1577	March 20, 2012
Paper printouts 21 CFR PART 820 (The Regulations)	4	1736	March 15, 2012
Audit Trails and the Meaning of Independent 21 CFR PART 820 (The Regulations)	0	1269	November 28, 2011
An Easy to Understand Guide - 21 CFR PART 11 21 CFR PART 820 (The Regulations)	0	1236	November 9, 2011
Definition 21 CFR PART 820 (The Regulations)	6	1807	August 25, 2011
What doe the term Biometrics refer to? 21 CFR PART 820 (The Regulations)	4	1700	August 25, 2011
Microbiolgy 21 CFR PART 820 (The Regulations)	2	1505	August 25, 2011
Number of lots 21 CFR PART 820 (The Regulations)	3	2517	August 25, 2011
Holding Time Studies on the Formulated Ready to Fill Bulk 21 CFR PART 820 (The Regulations)	2	1580	June 3, 2011
Weighing balance 21 CFR PART 820 (The Regulations)	9	7772	March 1, 2011
Define: Open Systems 21 CFR PART 820 (The Regulations)	4	1951	August 18, 2010
ERP validation 21 CFR PART 820 (The Regulations)	2	1508	June 10, 2010
FDA warning letters 21 CFR PART 820 (The Regulations)	1	1366	December 24, 2008
Products made during validation 21 CFR PART 820 (The Regulations)	1	1298	November 21, 2008
Electronic records in lieu of paper records 21 CFR PART 820 (The Regulations)	3	1528	September 29, 2008
Informatique files and two site of production 21 CFR PART 820 (The Regulations)	2	1338	August 8, 2008
Simple part 11 compliance for one system 21 CFR PART 820 (The Regulations)	9	2067	July 22, 2008