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19. May 2021 to 20. May 2021

Course: 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


Kurset fokuserer på GMP-regler relateret til computersystemer samt tolkninger og overholdelse af disse. Kurset er rettet mod QA medarbejdere og øvrige, som arbejder med kvalificering / validering af computersystemer.
Kurset er også velegnet til supportere, som har brug for kendskab til GMP-reglerne inden for IT.

Forudsætninger for deltagelse:

  • Du skal have gennemført grundkurset 4113se eller have tilsvarende basisviden om GMP

Hvis du er usikker på din GMP basisviden kan du købe og lave en online test her:
» 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



Course date

19. May 2021 to 20. May 2021


Scandic Copenhagen

Vester Søgade 6

1601 København


For yderligere information kontakt underviser Henrik Johanning

Customized courses?

We offer courses based on your needs and equipment.

Our trainers have many years of experience in the pharmaceutical industry and have all participated in inspections and internal audits.

Find out more about the possibilities for you.

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