Preparing for a Data Integrity (DI) Audit Garry Wright European Laboratory Compliance Specialist Apollo Hotel, Breda – 2nd February 2016 garry.wright@agilent.com . Perform Data Integrity self audits •Embed DI verification in self inspection processes •Train auditors in industry & in-house examples •Do unannounced audits, Quality walks etc. These tests can help verify whether: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Data Integrity and Compliance With Drug CGMP: Questions and Answers • Quality Culture. All topics will not be assessed in each audit, but this manual provides an ... documentation and testing. To evaluate the consistency of the data. Verify that a blank value can be retrieved from the database. focusing on data flow, system configuration, data access, authorization and testing Procedures for operation and use and if needed, agreements with IT Procedures for administration Periodic controls to ensure data integrity Access rights Audit trails Documentation Processes Testing for Data Integrity. Data Integrity: To check whether the data is well arranged and logically placed in the database. How do you test data integrity? Data is specific to the time it is collected. Migration Testing is a verification process of migration of the legacy system to the new system with minimal disruption/downtime, with data integrity and no loss of data, while ensuring that all the specified functional and non-functional aspects … Data integrity testing refers to a manual or automated process used by database administrators to verify the accuracy, quality and functionality of data stored in databases or data warehouses. Pharmaceutical Guidanace November 5, 2018 Audit and Guideline, Audit and Routine Checklist Comments Off on DATA INTEGRITY – QUESTIONS AND ANSWERS 1,316 Views Data integrity requirements are embedded in system life DATA INTEGRITY – QUESTIONS AND ANSWERS. Verifying and validating the correctness & integrity of the data, stored in the database. •Spend time in the lab or manufacturing, late shifts •Focus on raw data handling & data review/verification Database Testing Checklist: 1. • Good Documentation Practice (GDP - ALCOA). Data integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. • Example Data Integrity Warning Letter. Data Governance and Data Integrity . There are a number of tests you can use to test data integrity. Testing the integrity of a database refers to the evaluation of all sorts of processes, operations and methods, used in accessing, managing and updating the database, whereas data integrity testing focuses on the accuracy and consistency of the stored data, so that these data produces out expected or desired results.

Data integrity is tested by the following tests: Verify that you can create, modify, and delete any data in tables. To ensure that the data values are being placed correctly in their respective tables or columns. Pharmaceutical Guidanace November 5, 2018 Audit and Guideline, Audit and Routine Checklist Comments Off on DATA INTEGRITY – QUESTIONS AND ANSWERS 1,316 Views For this reason, it’s crucial to verify completeness, soundness, and wholeness of stored data, third party data, and new primary data. • Data Integrity Statistics. What is Migration Testing? Page 2 of 24 Authors: Elayne Kimmett, Biogen ... simple, non-inclusive, checklist with yes or no answers, but to provide areas for investigation. DATA INTEGRITY – QUESTIONS AND ANSWERS. EMEAI LSAG Page 2 Agenda • Data Integrity / Data Life Cycle? Verify that sets of radio buttons represent fixed sets of values.