Skip to content

  • Home
    • GMP Detox Channel
  • Imprint
    • Data Protection
  • Downloads
    • Glossary
  • Contact us
  • Back to main page CCS
Posted on 25.09.201425.09.2014 by CCS

FDA Guidance for Industry / Draft: Management of Cybersecurity in MEDDEV

 

This guidance has been developed by the FDA to assist industry by identifying issues related to cybersecurity that manufacturers should consider in preparing premarket submissions formedical devices.

Read more: Guidance For Industry: Management of Cybersecurity

Contact us: talk@comes-services.com

CategoriesCCS links, CCS news

Post navigation

Previous PostPrevious Computervalidierung: Grundlagen, Regeln, GAMP 5, 18.-19. November 2014 in Baden-Baden
Next PostNext Part 11 and Annex 11 – Commonality Analysis for the number 11

Recent

  • AI validation and compliance (GXP) 11.11.2024
  • Visit our new GMP Detox – YouTube Channel 29.02.2024
  • New QMSR – US-FDA final rule (Part 820 / Part 4) 05.02.2024
  •  e-Validation Platform (eVP) – Confluence meets GXP 18.12.2023
  • Online Training – ISPE GAMP 5 – second edition 02.10.2023
  • Final EMA GCP Guideline on computerized systems 10.03.2023
  • Neue Revision des AiM der ZLG für computergestützte Systeme (2022) 15.02.2023
  • GXP Outsourcing für IT Abteilungen, Projekte und externe Lieferanten 07.02.2023
  • Concept Paper on the revision of Annex 11 18.11.2022
  • ISPE GAMP 5 – Second Edition – Training 31.10.2022

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 - 2024