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 Group 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 involves maintaining and ensuring the accuracy and consistency of data throughout its entire lifecycle. It is a foundational element in the design, implementation, and use of any GxP system that stores, processes, or retrieves data.

To uphold data integrity, compliance with regulatory standards such as 21 CFR Part 11 and EU Annex 11 is essential. These regulations support accuracy and consistency in GxP processes and equipment, aligning with the ALCOA+ principles for data integrity (Attributable, Legible, Contemporaneous, Original, Accurate, Available, Enduring, Complete, Consistent).

Ensuring data accuracy and consistency

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 partner with QbD Group?

EXPERT TEAM WITH YEARS OF EXPERIENCE

With years of experience managing projects across various GxP environments, QbD Group is your trusted partner in ensuring data integrity and compliance.

We are here to help you:

Understand the data flow and data usage in GxP processes.
Identify which data is critical to GxP compliance.
Define the appropriate lifecycle and approach to data integrity.
Ensure the integrity of your data while maintaining compliance with relevant regulations.

Get in touch

Looking to ensure the integrity of your data?

Our expert team offers tailored solutions to help your company meet data integrity requirements with confidence.

Contact us today to learn how we can help safeguard the accuracy, consistency, and reliability of your data throughout its lifecycle.

Data Integrity

What is data integrity?

Ensuring data accuracy and consistency

Why partner with QbD Group?

Related content

A Complete Guide to Computer System Validation

Digital Health - Exploring the landscape and future opportunities

How to keep computerized systems in the operational phase

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

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

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

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Standards and regulations for software used in Medical Devices

Annual Product Quality Review in Pharma

21 CFR Part 11 compliance checklist

Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems

Verification & Validation of Artificial Intelligence/ Machine Learning Medical Devices

GAMP categories for computerized systems: what are they and what are they for?

EUDRALEX Volume 4 Annex 11 Compliance Checklist

From V-model to Agile: how to embrace automation as part of the computerized system validation approach

Get in touch