GMP requirements for Computer Systems and Data Integrity

Course description

This course focuses on GMP requirements as they relate to CS, as well as interpretations of and compliance with these requirements. The course is aimed at QA staff and anyone else involved in qualifying/validating CS. The course is also suitable for support staff with a need to familiarize themselves with the IT-specific GMP requirements.

Course outline

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
• “Cloud validation”

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

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.

Learning objectives

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

Prerequisites

• Basic training/knowledge in GMP / Quality systems.
• You should have at least 6-12 months experience from working in GMP regulated industry.

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