News

Data Integrity and Validation Issues identified during GMP Inspection

The FDA issued a Warning Letter due to non-compliance with cGMP, including Data Integrity and Validation issues, to a Canadian manufacturer of over-the-counter drug products.

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New Warning Letter - Quality Oversight in the Focus

Production and laboratory processes are for sure still a hot topic in inspections. But investigators are also focusing on the role of the Quality Unit and Quality Oversight.

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Data Integrity for Analytical Instruments connected to a LIMS via a Middleware

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 6: How can I handle analysis devices that are connected to a LIMS via a middleware? The manufacturer does not allow access to the original data in the automated analyser though.

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Data Integrity Violations detected by the FDA at US Company

Besides several Quality Unit related failures, a Warning Letter of the U.S. FDA mentions an enormous number of Data Integrity violations. Here you can read the remedations expected by the FDA.

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Ongoing severe Quality Deficiencies lead to regulatory Action - Part 1

The second Warning Letter within six months reveals fundamental issues in quality management. Learn more about the new FDA warning letter to US company Akorn.

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Is the Audit Trail Review required for Electronic Health Records?

MHRA´s GCP inspectors have recently seen various types of Electronic Health Records (eHRs) during their investigator site inspections and in several cases they have given major findings.

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Regulations concerning the handling and management of data from "small" computerised systems?

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 5: Are regulations necessary for the handling and management of data generated by small systems (e.g.  pH meters, filter integrity testers, etc.)?

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Deletion of Data: Does it have to be regulated in a SOP?

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 4: Does the deletion of data have to be regulated in a SOP?

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Warning Letter on Data Integrity Issues in the Microbiological Laboratory

Among other things, insufficient or missing reports of test results in a microbiological laboratory resulted in a Warning Letter addressed to the company concerned. Read more about the Warning Letter to Hospira Healthcare India Pvt.

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Ensuring the data integrity of cloud service providers

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 3: What agreements need to be included in contracts with cloud service providers in order to ensure data integrity?

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