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	643	May 22, 2018
Software validation - network and computer system validation 21 CFR PART 820 (The Regulations)	3	2068	August 1, 2018
Medical Device Production and the Importance of the Quality Plan [VIDEO] ISO 13485	0	908	May 28, 2018
All You Need to Know About Quality Policies – ISO 13485 : 2016 [Video] ISO 13485	0	836	May 23, 2018
Validation of an ERP System 21 CFR PART 820 (The Regulations)	7	2762	April 25, 2016
New product qualification with ETO sterilisation (Validated Process) 21 CFR PART 820 (The Regulations)	0	1056	May 21, 2014
Training records - signatures 21 CFR PART 820 (The Regulations)	2	1546	September 29, 2013
Vendor qualified software on a database version that isn't qualified by the vendor 21 CFR PART 820 (The Regulations)	1	1143	June 14, 2013
Requirements for QA to sign at the end? 21 CFR PART 820 (The Regulations)	6	1585	May 16, 2013
Automatic validation of data by the system 21 CFR PART 820 (The Regulations)	2	1157	January 11, 2013
PRODUCT REGISTRATION DOSSIER in C.T.D format 21 CFR PART 820 (The Regulations)	3	1398	December 6, 2012
ERP system on a multi-tenant host 21 CFR PART 820 (The Regulations)	2	1342	June 11, 2012
EO and Gamma Product Adoption 21 CFR PART 820 (The Regulations)	0	1410	March 22, 2012
Revalidation for Materials Change 21 CFR PART 820 (The Regulations)	4	1451	March 20, 2012
Paper printouts 21 CFR PART 820 (The Regulations)	4	1596	March 15, 2012
Audit Trails and the Meaning of Independent 21 CFR PART 820 (The Regulations)	0	1145	November 28, 2011
An Easy to Understand Guide - 21 CFR PART 11 21 CFR PART 820 (The Regulations)	0	1123	November 9, 2011
Definition 21 CFR PART 820 (The Regulations)	6	1673	August 25, 2011
What doe the term Biometrics refer to? 21 CFR PART 820 (The Regulations)	4	1573	August 25, 2011
Microbiolgy 21 CFR PART 820 (The Regulations)	2	1377	August 25, 2011
Number of lots 21 CFR PART 820 (The Regulations)	3	2350	August 25, 2011
Holding Time Studies on the Formulated Ready to Fill Bulk 21 CFR PART 820 (The Regulations)	2	1474	June 3, 2011
Weighing balance 21 CFR PART 820 (The Regulations)	9	7586	March 1, 2011
Define: Open Systems 21 CFR PART 820 (The Regulations)	4	1833	August 18, 2010
ERP validation 21 CFR PART 820 (The Regulations)	2	1370	June 10, 2010
FDA warning letters 21 CFR PART 820 (The Regulations)	1	1264	December 24, 2008
Products made during validation 21 CFR PART 820 (The Regulations)	1	1146	November 21, 2008
Electronic records in lieu of paper records 21 CFR PART 820 (The Regulations)	3	1396	September 29, 2008
Informatique files and two site of production 21 CFR PART 820 (The Regulations)	2	1208	August 8, 2008
Simple part 11 compliance for one system 21 CFR PART 820 (The Regulations)	9	1915	July 22, 2008