Skip to content

  • Home
  • Imprint
    • Data Protection
  • Downloads
  • Glossary
  • Contact us
  • Back to main page CCS
Posted on 18.10.201218.10.2012 by CCS

For Freelancers and Professionals: Join the CCS network

If you are a compliance subject matter expert, consultant, or professional in the areas of  GMP, GDP, GCP, GLP or medical devices and you are seeking for a project assignment, you can contact CCS by email at freelancer@comes-services.com right now.

Read more…

CategoriesCCS inside, CCS links, CCS news

Post navigation

Previous PostPrevious EudraLex – Volume 4 GMP – Chapter 1 – Pharmaceutical Quality System – revision 3 and Chapter 7 – Outsourced Activities
Next PostNext Rules and Guidelines in 2013 for Computer System Validation

Recent

  • ISPE GAMP ® 5 (Second Edition) coming soon! 17.06.2022
  • OECD – Advisory Document on Good Laboratory Practice on GLP Data Integrity 10.02.2022
  • IPA Annual GMP Update 2021 28.09.2021
  • MHRA – The data lifecycle 04.09.2021
  • PIC/S PI 041 – Final Version – 1. July 2021 17.07.2021
  • GCP: Guideline on computerised systems and electronic data in clinical trials [EMA] 06.07.2021
  • Live Online Training: How to prepare for distant Assessments – ECA Academy 09.01.2021
  • MHRA and FDA Joint Paper ‘Data Integrity in Global Clinical Trials’ 01.07.2020
  • GMP Paper 4.0 – a retrofit solution 14.03.2019
  • PDSVision Medizintechnik Veranstaltung 17.01.2019

Tags

  • "Draft PIC/S Good Practices for Data Management and Integrity"
  • - Computerised Systems
  • 21 CFR Part 11
  • AIDE MEMOIRE - Annex 11: ZLG_AM_QS_07121202
  • ANNEX 11
  • audid trail review
  • audit trail
  • CCS
  • CPP
  • CQA
  • data integrity
  • EUDRALEX
  • GAMP
  • ISPE
  • QbD
  • retrospective computer system validation
  • revision January 2011

Archives

Search

By month

Categories:

About

"comes" is the Latin word for comrade, companion, associate, partner. The word "comes" derives from com- "with" + ire "go.".
  • facebook
  • LinkedIn
  • Xing
comes compliance services