Kom med på holdet
13. December 2021 til 14. December 2021

Kursus: GMP requirements for Computer Systems & Data Integrity

A review of FDA and EU requirements and interpretations relating to computer systems (CS)

Course objective

The aim of the course is to increase participants’ knowledge of:

  • Existing GMP and EU requirements and interpretations relevant to CS
  • Validation of various types of CS, using a risk-based approach
  • Requirements and actual interpretations relating to Electronic Records and Electronic Signatures, based on 21 CFR, Part 11
  • Warning Letters issued in the area of Data Integrity and CS Validation
  • Data Integrity and IT Security

The courses are held in collaboration with Key2Compliance® - and subject to copyright


  • Basic training/knowledge in GMP / Quality systems.
  • You should have at least 6-12 months experience from working in GMP regulated industry.
  • You must have completed the basic course 4113se or have equivalent basic knowledge of GMP

If you are unsure of your GMP basic knowledge, you can buy and do an online test here:
» SmartGMP® (Trin 1)

Course content

Day 1 – THEME: General requirements/CS validation
  • Background for CS validation
  • Relevant GMP requirements, FDA
  • Relevant GMP requirements, EU
  • The “life-cycle model”, risk and CS testing
  • Off-the-shelf software
  • Presentation of validation information for the FDA and the EU
Day 2 – THEME: Part 11 – Electronic Records/Electronic Signatures (ER/ES)
  • Part 11 – Background and Scope
  • Archiving and copying of ER and ES
  • User Access – User Rights
  • Audit Trail, Operational checks and Device checks
  • ES
Day 2 – THEME: Data integrity
  • Background: Definition of Data Integrity (ALCOA)
  • IT Security
  • Protect your data!
  • Electronic Records or hardcopy?
  • IT behaviour
  • Examples of Data-Integrity Warning Letters
  • Wrap-up

Both course days also include a review of relevant warning letters.

Genau Talks

John Lee, Executive Director of Pharmaceutical Compliance Associates, and Henrik Johanning, CEO Genau & More discuss Computer Systems Validation and Part 11. When do you have electronic registrations and signatures and thus need to be in compliance with Part 11? When you press the enter button and you save data to a hard drive or USB drive, of course depending on whether or not you have to follow predicate rules (predicate rules interpreted as GMP).

Genau Talks is a series of videos that focuses on questions and tendencies within compliance. We would like to share these with you.


Henrik Johanning




13. December 2021 til 14. December 2021


DGI Byen

Tietgensgade 65

1704 København V

Kontakt os

For yderligere information kontakt underviser Henrik Johanning

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Vores undervisere har mange års erfaring fra pharmaindustrien og har alle deltaget både i inspektioner og interne audits.

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