• There are no suggestions because the search field is empty.

What to focus on when validating a computer system

Author Avatar
QbD Group
Software Solutions & Services
Pharma & Biotech

In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.

What to focus on when validating a computer system | QbD Group
2:11

In our first blog we discussed the definitions of validation and computerized systems. Assessing the health of the system means checking whether the system operates according to the needs of the process for which it was acquired. This can be done with the validation of the system and must be done periodically in the operational phase.

How do you start? There are many different computer systems, each requiring a different validation effort, but the validation approach should always be consistent. The following approach can be applied to each computer system.

  • Describe the system, its functionality and for which process(es) it is being used.
  • Analyse the system’s impact on patient safety, product quality, data integrity, GxP processes, etc. If the system has a direct or indirect impact on the patient safety or GxP processes, the system has to be validated.
  • Assess within which GAMP5® category the computer system falls. This can be category 1 (infrastructure software), category 3 (non-configured product), category 4 (configured product) or category 5 (custom application). Since the introduction of GAMP5®, category 2 no longer applies.

The category classification of GAMP5® is a tool for determining the software’s complexity and its risks. For example, in the validation of an ERP software category 4 or 5, after an impact and risk analysis (for each of its modules), it can be decided not to validate some of the modules (e.g. Finance) because it has no impact on the patient safety. The figure below gives an indication of within which category each type of software falls. This depends on how the software is being used within the company.

Which software belongs in which category

*
COTS Commercial Off-the-shelf software
DMS Document management system
ERP Enterprise Resource Planning
LIMS Laboratory Information Management System
PAT Process Analytical Technology

 

Now you’ll have a better understanding of each category and which systems they include. In the next blog we’ll discuss the characteristics of these systems. Don’t hesitate to contact us if you have any questions concerning computer system validation.

 

Stay ahead in life sciences

Keeping up with the fast-paced life sciences industry doesn’t have to be overwhelming.

Our newsletter delivers the latest insights, industry updates, and expert content directly to your inbox, helping you stay informed and make smarter decisions.

Circles-banner-short

Discover more expert content

preview_image
Webinar

From Requirements to Code: a unified MDSW development cycle that covers all requirements

Watch our webinar on demand to master medical device software development. Learn about IEC standards, cybersecurity, AI integration, and FDA expectations.
preview_image
Whitepaper

Mobile health on the rise: exploring the regulatory landscape for reimbursement

This whitepaper will help you navigate the maze of the DTx regulatory environment, highlighting several important countries and regulations.
preview_image
Whitepaper

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

Learn how to comply with GMP, GCP, and GLP regulations using the GAMP 5 Software Validation Approach. Download the whitepaper for more insights.
preview_image
Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.
preview_image
Blog

What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?

It shouldn’t be a surprise that today, “Near-Patient Testing (NPT)” and...
preview_image
Blog

When does Annex XIV apply in Performance Studies, and what key documentation is needed for compliance?

In the European regulatory landscape, conducting performance studies for in...
preview_image
Blog

How to define your Clinical Performance Strategy?

1. Start with a clear intended purpose A strong clinical...
preview_image
Blog

The Holy Grail: Achieving Inspection Readiness

In a previous blog post, we talked about the various activities...