How GxP Validation Protects Data Integrity

Data Integrity in GxP systems is an essential component to ensuring the product quality and patient safety in regulated industries like pharmaceuticals, medical technology, and biotechnology. It is critical to keep the company compliant with the regulatory requirements like FDA, MHRA and EMA and aligned with the Good Practices (GxP). 

Issues in data integrity can cause a reputation risk to customers, partners, and or investors and rectifying these issues can be costly, time consuming and might disrupt the operations. For a system to maintain data integrity, GxP compliance, and audit readiness, it should avoid common pitfalls. One of the major pitfalls in data integrity is the use of unvalidated systems that leads to non-detection of data inaccuracies, non-correction of system failures, and compliance issues. 

Computer System validation contributes to ensuring that data integrity is in place by satisfying predetermined standards when it comes to data accuracy, system performance, system access security, and system tracking. GxP Validation enforces system features that supports: 

• ALCOA+ data integrity requirements which ensures that data collected and processed are Attributable, Legible, Contemporaneous, Original, Accurate and Complete. Validation involves verifying that the data are attributable to an individual, legible to ensure that it is readable and not susceptible to alterations, contemporaneous to record the time of the action against a timestamp, original to ensure it is unaltered and in its true state, accurate to ensure that values or processes represents the actual process conditions, and complete with all the information. 

• Access control security which ensures that only those users with the right permissions can access the corresponding functionalities. 

• Audit trails that provide a complete record of all the transactions. 

WHY ARBOUR GROUP? 

Arbour Group is a leading provider of validation services dedicated to life sciences for over 30 years with Expertise in Regulatory Expectations, including US & EU GxP, Data Integrity HIPAA, and GDPR. 

With our knowledge and dedication, we will help your organization transform your data to be reliable and accurate throughout the data life cycle.