GxP for Developers

What is GxP

During a lifecycle of a product, GxP is applied in order to protect the end users, to assure the quality of the product and the integrity of the data.

GxP is a generic term that refers to ‘Good Practices’ that are followed by companies working on products used by humans. The collection of quality guidelines established by the company ensures these products are safe. The quality regulations which are followed include the whole process during product development, quality control, storage, and release processes.

As GxP is a globally used term, the ‘x’ gives information on the company’s manufacturing area and can mean clinical, research, or distribution for example GRP= Good Research Practice, while GCP means Good Clinical Practices.

GxP in the It World

When we talk about GxP in the development world, the must is to have a setup processes, standards, and procedures which are followed during the development process. Only with these existing, you will be able to meet the regulatory audits. Usually, these are established as GxP-Regulated processes.

These processes do not include only the software development lifecycle as a whole, but also how the inventory and all of the systems are maintained, it also matters how the data is recorded and protected, the internal and external trainings provided to the people part of the company plus even the actions which are taken during incidents.

It’s all about the processes

When you consider do you have an internal process meeting GxP standards, think about the following :

    • What are the activities performed during the development of the system and are there any required validation deliverables that need to be established
    • Do you have proper processes established for the Validation and Qualification of the product which is developed? Have in mind Validation is usually related to a process, while the qualification is usually connected to the used equipment.
    • All of you people need to have proper qualifications based on the role they have as part of the team.
    • Be sure you have a proper process set up in case of occurred problems or incidents. Consider how you apply changes as well, these should be controlled.
    • Ensure Data Integrity by ensuring all of the data collected is correct, traceable, and reliable though the whole data lifecycle. Can prove that in case of an audit?
    • Be sure you have company followed procedures inlined with the developed software
    • Do not forget about the third-party systems that you are connected to, Be sure you have proper processes and agreements set up with them.

GxP for Data

The system requires the appropriate level of validation to ensure that it complies with the different regulations. The term which is usually mentioned when we talk about GxP is Data Integrity. When we talk about data integrity, we talk about data completeness, data consistency, and data accuracy.

In short, we talk about the process established during the data lifecycle – how we generate the data, how we use it, how we process it, and how it’s destroyed. It is valid for both manual and electronic data records.

Make a difference. Now!

You need to be focused on building a process strategy, where you focus on product quality, regulated data, and the safety of the end users. Establish validations and standards which ensure that your software is aligned with company quality management processes.