Electronic health records
...adverse events recorded in the EHR) resulting in missing visits and data in the printed records. The source data printouts did not contain all the relevant source data. For example,...
...adverse events recorded in the EHR) resulting in missing visits and data in the printed records. The source data printouts did not contain all the relevant source data. For example,...
...each scenario. Tracy finished by providing an update on the GXP Data Integrity Guidance consultation and also highlighted that future Data Integrity blogs were in the pipeline; watch this space!...
...Singapore. The event focussed on the next steps in relation to data integrity for both GCP and bioequivalence (BE) inspections, providing both MHRA and FDA perspectives in all sessions. This...
...the media relating to data governance and data integrity failures at manufacturing sites, despite the publication of MHRA and international guidance for industry. This thought provoking session was presented by...
...up in our next blog… Increased focus on data integrity and governance systems has led to serious consequences for several companies. Data integrity is fundamental in a pharmaceutical quality system...
...the company’s Pharmacovigilance department. For example, reconciliation of safety data between departments/parties, audit, source data verification, etc. The emphasis should be on the collection of high-quality data on the patient’s...
...detail in the areas of Product Quality Review (PQR) and Data Integrity, sharing common deficiency themes as well as specific examples. Common PQR issues related to the scope, accuracy and...
...same and some clinical trials pose only a minimal additional risk in relation to safety and data integrity. The advantages to adopting this approach are potential reduced costs and better...
...versus the data and the expectations for site ability to access and retain not just the data but the metadata and audit trails during and at the end of a...
...Senior GCP inspector presented an informative session on Data Integrity and the mechanisms by which this can be achieved. Data Integrity is becoming an increasing focus of the inspectorate with...