Data Integrity Consulting & Services
Data without integrity puts our patients at risk.
Data Integrity Approach
Data Integrity is a ‘hot topic’ because many of the standard controls implemented decades ago for paper records, have not yet been implemented for electronic records and computer systems. FDA, EMA, MHRA, WHO, PIC/S, ISPE, PDA – All of these organizations have recently published data integrity standards and guidelines.
Gap Assessments
If you haven’t thought about data integrity before now, the best place to start is with a Gap Assessment. This will let you know where current systems and practices are already ensuring data integrity and where there are gaps to address.
Policies and Procedures
A first step to ensure data integrity is the implementation of a Data Integrity Policy and the development of procedures to embed data integrity best-practices into daily activities.
Data Governance Programs
As your data integrity practices mature, a Governance Program will ensure ongoing compliance and provide a forum for continuous improvements.
Data Integrity Consulting & Services
Need help with your Data Integrity? Validation Center has seasoned experts to help.
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Data Integrity Client Success Story
An EU-based nutraceutical manufacturer was preparing for an FDA inspection of their US-based product testing laboratory and knew that data integrity would be a key topic.
Although the company’s off-the-shelf laboratory applications had been validated by the software vendors, QA and IT management thought there might still be data integrity compliance gaps.
Our auditors performed an assessment that identified gaps in validation coverage, audit trail reviews, record retention policies, user access controls, disaster recovery plans, and data integrity monitoring.
With help from our team, the company was able to execute a 5-week plan to close the gaps prior to the FDA inspection.