Validating electronis databases to ensure accuracy and integrity of data

10 Sep

This guidance document made a number of helpful suggestions for systems (both electronic and paper-based) designed to ensure data integrity.These systems should include: Complete – Data records should contain all data including repeat or reanalysis performed on the sample (21 CFR 211.194) Consistent – There should be consistent application of data time stamps in the expected sequence.This document also sets the expectation that pharmaceutical companies, importers and contract labs will review the effectiveness of their data governance systems to ensure data integrity, and that companies outsourcing activities should verify the adequacy of comparable systems at the contract acceptor.Two other recent guidance documents that contain valuable information and are worth going through are MHRA’s ‘GXP’ Data Integrity Guidance and Definitions published in March 2018 and the FDA’s Data Integrity and Compliance With c GMP published in April 2016.We provide experienced professionals knowledgeable about FDA regulations to conduct a thorough data integrity assessment of your laboratory informatics environment to identify data integrity risks.Working with an external consultant that has expertise in data integrity evaluations to audit your laboratory environment is best practice, as an expert with fresh eyes will be able to effectively locate data integrity issues you missed.Astrix professionals have the skills and expertise necessary to architect, implement, integrate and support best in class solutions for your organization’s laboratory environment.Our professionals can also help to ensure that your laboratory systems and staff comply with the FDA’s data integrity mandates.

Don’t forget who your clients are and why their data protect is so essential.Enduring – Data should be recorded in a permanent, maintainable form for the useful life.Available – Data should be available/accessible for review/audit for the life-time of the record.Astrix Technology Group recently sponsored a webinar conducted by Joseph Franchetti, FDA Regulatory Compliance Specialist, that highlighted the current thinking of regulatory agencies on data integrity.In this blog, we will provide a summary of some of the most important points made by Mr. In this last point, “complete data” refers to raw data/observations generated in the course of an analysis, the associated metadata which helps to provide the proper context, and the audit trail when using computerized systems that shows how and why the data has been modified and who it has been modified by.The threat of hacked passwords or a data breach are nightmares as a business owner. It is essential to know precisely what is data integrity is to ensure your business is safe at all times. You will also sometime hear the reference”data quality.” That can lead to some confusion.Understanding how to provide data security can help your business stay protected, or you may end up with costly data recovery solutions. The integrity is vital to your success and reputation. For data to have “integrity,” it must have a complete or whole structure.While companies in the United States typically look to the FDA for guidance on data integrity regulations, it can also be valuable to stay up to date with regulatory guidance published by agencies in other parts of the world, as regulatory agencies worldwide are all moving in the same direction with respect to thinking on data integrity.Towards that end, the Medicines and Heathcare products Regulatory Agency (MHRA) in the United Kingdom published a guidance document in March 2015 entitled GMP Data Integrity Definitions and Guidance for Industry.Knowing how to improve your data security is a good move when going forward with your online business.Data integrity is not just about protection digital information.