Data Integrity
Ensure accuracy and consistency throughout the data lifecycle
Data integrity is as critical as ever, from equipment and laboratory systems to automated systems and IT infrastructure. QbD Group offers customized expertise to help your company comply with the latest regulations.
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: Data can be traced to the person or system that generated it.
- Legible: Data is readable and permanent.
- Contemporaneous: Data is recorded at the time of the activity.
- Original: Data is the first-recorded version or a certified copy.
- Accurate: Data is correct, truthful, and free from errors.
- Available, Enduring, Complete, Consistent: Extended ALCOA+ principles ensuring data remains accessible and reliable throughout its lifecycle.
Ensuring data accuracy and consistency
Regulatory compliance
Compliance with 21 CFR Part 11 and EU Annex 11 ensures data accuracy and consistency in GxP processes.
Data security
Protect sensitive data from unauthorized access, manipulation, and loss throughout the data lifecycle.
Risk mitigation
Early identification of data integrity issues prevents costly regulatory findings and product recalls.
Audit readiness
Well-maintained data integrity practices ensure you are always prepared for regulatory inspections.
Why QbD Group
Your trusted partner
With years of experience managing projects across various GxP environments, QbD Group is your trusted partner. We 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.
Let's talk Software
From system validation to digital transformation, our software experts are ready to support your journey.