Data Integrity
Data integrity is as critical as ever, from equipment and laboratory systems, to automated systems and IT infrastructure.
Are you looking for data integrity services? QbD offers customized expertise to help your company comply with the latest regulations.
Don’t hesitate to contact us for more information.
What is Data Integrity?
Data integrity is the maintenance and assurance of data accuracy and consistency over its entire lifecycle and is a critical aspect of the design, implementation, and usage of any GxP system that stores, processes, or retrieves data.
Compliance with regulatory requirements such as 21 CFR. Part 11 and EU Annex 11 ensures data accuracy and consistency in GxP processes and equipment as well as compliance with the ALCOA+ principles:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
- Available
- Enduring
- Complete
- Consistent
Why QbD Group?
QbD has years of experience with numerous projects in various GxP environments.
We are happy to help you:Â
- understand the data flow and data used in GxP processes,
- understand which data is critical to GxP,
- decide on the lifecycle and approach to data integrity,
and ensure the integrity of your data and compliance with applicable regulations.
Tailored approach
The actual approach you want to take to ensure the integrity of your data is up to you.
Of course, this will depend on the system or equipment generating the data.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.